Category Archives: Medical Writing

MLR – Approaching Perfection

Medico marketing and medical communications are adding a novel approach to the dissemination of information by medical and healthcare industry. Nonetheless, improper marketing and communication can dampen the efforts of medical and healthcare industry. This is where Medical-Legal Regulatory (MLR) review steps in.

What do you understand by MLR?

MLR Review is an important step in healthcare promotion and marketing. This step ensures the accuracy, compliance, and credibility of content. The content is reviewed and approved by both medical and legal reviewers in compliance with guidelines and regulations.

Significance of Medical-Legal Regulatory Review

Every healthcare practice or product entering the market impacts lives. If the drug or device information is not conveyed accurately, it can lead to lethal outcomes. Thus, such information necessitates stringent verification and review as one wrong step can not only cost lives but may have a huge financial impact. Media trials leading to disrepute and functional collapse could be other added side effects. Therefore, if a product involves instructions for dosage, storage etc., the need for MLR review becomes paramount and non-negotiable  

  • False or unreliable information can get companies shut down and banned
  • Wrong marketing equals exit from the market
  • MLR adds credibility and a sense of security

In a world where healthcare promotion is moving towards digitalization and extensive marketing strategies, patient awareness of available options is increasing. Hence, MLR review has become even more necessary, but the question is how to evolve in this revolution?

Click Here:- 5 Steps Towards Freelance Medical Writing

Technology and Software in solving the problem

From paperwork to soft copies, the leap has been taken a long time ago. However, medical reviewers and writers are still one step away from the ideal. This is because the increased number of drafts, multiple revisions, and pressure of meeting the deadlines tends to create a gap in the development of a perfect document.

With tools and technology, we can fill the gap between creativity and accuracy. These tools allow us to move from “Leave behind Leaflets” to “Video content”. The process right from uploading a document to referencing a document, everything can be put in order and system.

Turacoz is opening its doors by introducing you to such tools and technology and welcomes you to be a part of the digital revolution. Turacoz is organizing workshops, webinars, and courses to guide and teach the new generation about MLR reviews.

“Perfection is the pillar of Turacoz”

Here is the detail of upcoming courses and workshops of Turacoz

  1. Certificate Course in Scientific Writing: 16th July,2022
  2. Workshop on “Freelance medical writing: A flexible career opportunity”: 9th July,2022.

Book your seat in advance at [email protected]

Literature Search – Building Block of Research Realm

How to know if an article or a journal is trustworthy source? Literature search forms the basic unit of trust for medical writing and communications. The past studies and research have so much to offer that the whole new healthcare world is based upon what has already been concluded. Before writing about any topic, we need to read and read about all that has been written and published. But is simply reading known as literature search?

What is literature search?

Literature Search is like a process in which the first step is to look for all the available evidence (books, journals, websites etc.) for a particular topic. The next step involves combining and assembling all the available data. Literature search is like searching for treasure. The next thing is to find the hidden facts and gaps in them. These gaps would become the basis for further research and questions in medical world.

Importance of literature search

The literature search is mostly done by researchers, scientists, doctors, students writing thesis, entrepreneurs and anyone seeking to find more and create much more. But why is literature search an important topic to learn?

  • Literature search forms the ground for further discussions, methods of study and provides solid content
  • Literature search offers an in-depth education about a specific topic and hence increases the understanding of the author
  • Literature search allows you to explore what is not answered yet in the world of science
  • The mistakes that had been done, the experience and achievements of previous studies is all in your hands
  • Literature research justifies the reason for your research and research methodology used
  • Point of reference gives life to your search and helps you sail through struggles of drafting an article

These are some of the major reasons why literature search is important but, there is no end to this question because literature search is giving power and intellect to your research topic.

Errors in deciding what to search and what not, destroys the whole process of medical writing. How to move towards a successful literature search?

Literature search is not about typing random keywords, it’s an art to find the real capital. Choose the right question or keywords, improve quality by sources or reliability, the tiny details make your work shine out. But if you know the right way and right stops then your journey is smooth. The guidance and trainings from the experienced ones make the road polished.

Turacoz is a pack of experienced and trained medical professionals, those who know the roots of medical writing. If you want to step in medical writing or struggling to draft a thesis then, you are on the right page. Turacoz is offering an online course about medical writing, the course commences soon.

Turacoz is a medical communication agency that knows the lock stock and barrel of medical writing and the scientific industry. You are just one click away from learning all about presentations, literature research, literature search referencing etc.

 Contact us at email: – [email protected] or mobile number :-+91 9758901021

Scientific Presentations: The Canvas of Medical Industry

Ideas and knowledge will be of no value if not transferred and communicated with the right words and some creativity. If you do not want blank faces staring back at you, it is important to put your message simply and innovatively. Presentations are a powerful way of unveiling valuable information, scientific research, training peers, etc. and keeping the audience engaged at the same time. But what makes a scientific presentation weigh heavier than any other? The value of a well-designed presentation is neglected in the medical world. Let us probe into the need for an impressive presentation.

Unlike journal publications which are text-heavy, structured, guideline-driven and use only scientific imageries for representation of data, power point presentations have the creative liberty. Presentations steer your way to take your research and knowledge into the world. And communication in a way that is understood by the audience is the responsibility of a medical writer. Here are some domains where medical writers and designers need to flip open PowerPoint and their creative genius!

  • Medical Education

Learning never ends for anyone. And likewise for the healthcare community. To support consistent academic and professional development, knowledge sharing, and with the ultimate goal to upscale health system for community, medical education is imperative and requires strategic involvement of medical writers. For any healthcare policy or clinical advancement to bloom, the medical fraternity needs to be part of medical education (eg Continuing Medical Education, CME for doctors) to maintain competency and lengthen the learning curve.

  • Conferences and Advisory Boards

Medical conferences andAdvisory Boards require robust impart of research and contribution to existing scientific evidence by Subject Matter Experts (SME) and Key Opinion Leaders (KOL). To speak their science, presentations become their canvas. In national and international conferences, 5 minutes of the presentation can describe their whole journey from deciding the motive to finding a conclusion. Textually light and graphical presentations welcome the attention span and add retention bonus.

  • Webinars and Training Courses

In a one-click away generation, webinars and courses are important means of learning. To learn something new from experienced professionals, presentations bring all the important information. In the medical industry where nobody has enough time, short presentations with important facts are the finest assets.

  • Healthcare Sales Force Training

If a pharmaceutical company has to bring its brand or product to the market, its sales team should be well educated about what are they selling and how will it affect public health. Simple informative training presentations for such serve a huge purpose of empowering every stakeholder with every possible information.

This list is long, but the crux, precise. Presentations are not just a deck of slides; they give you a whiteboard (and lots of colors too!) to showcase all a medical writer has got for the healthcare world. A medical or scientific presentation should be visionary, informative and to learn what are you missing. So, how do you make the best of it? You are on the right page, as Turacoz will guide you through crafting an impressive presentation through its upcoming certificate course on Medical Communications: Medical Writing for Medical Affairs.

Turacoz is a medical communication agency that knows the lock stock and barrel of medical writing and the scientific industry. You are just one click away from learning all about Presentations, literature research, etc.

Click here to know more

Medical Podcasts

Digitalization has recalibrated healthcare to new heights. It is imperative for healthcare professionals and medical students to stay abreast with scientific and clinical advancements, but ironically the rush hours of duty leave them very little room and time for it. Nevertheless, newer technological options have widened the windows to healthcare communications and one such innovation is the emergence of Podcasts. Podcasts have been around for some time providing audio experiences to diverse fields but its passage into the healthcare industry has unlocked a whole new dimension. 2005 to 2016 has witnessed increased publications about it, reinforcing the boon of medical podcasts.

What is a Medical Podcast?

Podcasts are the radio of a new era; they are digital audio files which can be easily downloaded and accessed at convenience. They have been instrumental in overhauling medical education. While some fields of medicine have active podcasts available, some are yet to venture into it.

Here is a list of Benefits of Podcasts

1. Sensory Experience

An audio format certainly adds more poundage to information. It gives depth to the kind of medical knowledge being disseminated and expedites assimilation due to its high sensory quotient.

2. Convenience

Needless to say, it is the most convenient mode of receiving information. All one would need is a listening device on the head and passion to learn, inside the head!

Click Here:- Scientific Presentations: The Canvas of Medical Industry

3. Expanding Perspectives

Podcasts offer more creative perspectives through strong mental imageries and critical thinking.

4. Deeper Engagement

Deep listening is a salient quality that a medical practitioner, willingly or unwillingly, needs to cultivate. Podcast listening helps practitioners have deeper engagement with not only the content, but also with their peers and patients. Practitioners who have experienced podcasts can even share the recordings with their patients and help them understand their conditions, treatment strategies, etc. The conversation and terminologies which are often tough to explain are made easy with podcasts.

5. Multitasking

One of the main reasons behind the popularity of medical podcasts is the liberty of
 multitasking. Podcasts will not ask for any extra time from your busy schedules. You can learn a new skill while folding your clothes or listen to case studies while walking. Listening to podcasts while working also has a positive impact on your co-ordination skills and judgment ability.

6. Pocket Friendly

A podcast gives you freedom from enrolling and paying for books. They are certainly
less expensive and an entertaining way to learn. One can gain knowledge about anything from the medical industry to stories of patients. Podcasts have their way to get involved with you and your daily life. You can play them anytime and anywhere and it will not burn a hole in your pocket.

7. Shrinking the Stress

The power of healing others leaves an impact on HCPs, nurses and other medical caregivers. Witnessing pain and suffering daily asks for the mind and eyes to rest. Auditory simulations can be deeply relaxing since they enhance your imagination and help in de-stressing.

8. Challenging Boundaries

Podcast is an equally well-equipped mode of disseminating medical information as a manuscript or a book and is a blessing for medical students and professionals who are visually impaired. Podcasts break the boundaries of physical challenges and keep them well-informed and aligned to the latest of the healthcare industry.

Medical podcasts are providing convenient access to medical knowledge. From just prescribing medications, to new clinical advancements, to drug development and information on diseases, podcasts are bringing a huge shift. However, unlike written content like manuscripts, emailers, newsletters and marketing documents to name a few, a podcast needs additionally skilled professionals to develop it. Considering the nuances of presenting accurate medical information through precise planning, language and grammar, diction, formatting, audio rendering, etc., ‘podcasting’ has now formally entered the world of medical communication. Having worked for over 85 podcast projects, Turacoz has proven to be one of the best in the game! And we are glad to share our knowledge and skills with all the interested ones through an upcoming webinar on how podcasts are created. Visit the link: https://turacoz.com/podcast-from-medical-education-to-scientific-dissemination/

Reference

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5717411/

CERTIFICATE COURSES

“Life is a puzzle where we keep trying to fit pieces to be successful. But there is no one single move or mantra.”

As it brings forth equally-chances and struggles, opportunities, and failures, wishes and disappointments, it becomes imperative to choose our area of focus, wisely. Every science student, be it medical or academic, wishes to be part of the contributory chain towards growth of healthcare. However, more often than not, there emerges a gap between what you study and what the market demands as a professional. This empty space of unlearnt skills is filled by wonderful opportunities in the form of courses, webinars and specific skill-based workshops. Without a shadow of doubt, these options are a new look at the education system.

What makes Turacoz distinct from ordinary learning institutes?

By the face of it, Turacoz is well-known as a valuable medical communication partner in the healthcare industry but there is much more than what appears. Turacoz is not only a service- oriented organization but also through its regular courses and webinars, is a grooming and upskilling platform for learners with diverse age and experience spectrum. It is priming every aspiring science geek into a medical writer; exploring talent and polishing it with practical knowledge and technical skills is the best way Turacoz is giving to society the richness of knowledge

Turacoz has brought evolution from academic learnings to target based learnings. The courses based on medical writing, scientific publications, scientific documents etc. talks about the practical needs and not just theoretical writing skills.


Turacoz knows the healthcare market from its roots, and one gets to learn from the experienced and real evidence.


Being one of the very few organizations which envision empowerment of women, Turacoz encourages women to join the workforce and provides them opportunities to rebuild their career despite long gaps.


Turacoz does not impose qualification-based boundaries and hence bias is never part of its modus operandi. If you have a scientific background and interest in writing, you will be groomed without any judgment.


In the COVID era, when millions of people were losing jobs and colleges were shut down, education and growth was posed with a big question mark. But Turacoz never shut its doors. Turacoz being a wide spectrum stage never stopped offering jobs and mentorship and continued to cultivate their Skill Development Programs (TSDP) manifold


Turacoz gives a place to connect with like-minded people and increase your network in the professional world of healthcare research and communication.

Learning the perks of courses
The world is changing at one scroll, and it is really important to walk along with the change Is a certificate program a replacement for a degree? NO. Is it an addendum to your qualifications? YES. It is a flavor-enhancer if we can put it in a more aesthetic way! Webinars, workshops and courses are bettering the chance to fit the missing pieces in a professional boardgame. There are new streams of clinical and scientific research opening every day and these options are guiding you to supplement your knowledge-bank with skills and other perks as well.

Not so heavy on the pocket

For a medical writing course/certificate or a webinar, you certainly do not need a pocket as deep as you would for a master and diploma. The expenses entailed in these courses can be easily managed with work and personal life. So, why not choose something which is light on your pocket and adds weight to your resume at the same time.

Targeting the skills

‘By the books’ sounds as medieval as it can get. The need of the hour is to focus on what more we can think, innovate and contribute. You definitely need your fundamentals in place, but only to chaperone new skills. The short-term courses offered by Turacoz are by subject matter experts who freight real-time experiences and know in depth about the skills that can raise your chances to get a job.

Convenience

The biggest advantage of the short-term courses is the convenience they provide you in terms of time, venue and menu. While physical workshops undoubtedly render a more interpersonal leverage, advent of online options have made it more accessible. Professionals and experienced guides take you through a 8 by 8 window, into a world where you get to learn from real stories and facts. Through distance learning and online classes, certificate courses are letting you maintain your work-life balance like a boss.

Long-term benefits

With professional and targeted skill enhancement courses, you are planning a life ahead with surety. You add points in your resume and finesse in your work, and it helps you in raising your visibility at work.

Making your career and passion meet

You enjoy science and you love writing, but you never knew how to get these two shake hands! With a flair of writing along with good scientific knowledge, one can turn into an ace medical writer.

Diversity

Courses and workshops have a wide vision and no boundaries set and so you can get admission at any phase of your life. All you need is passion and hunger to learn. In Turacoz, be it a science graduate, or a healthcare professional or a PhD, anyone can learn medical writing.
“A decade back, someone doing a course was considered a hobbyist; nor was scientific writing considered an independent skill or profession. However, with unfolding layers of clinical research and its allies, medical writing emerged as an indispensable province. The role of such courses and workshops has hence evolved in widening the learning curve, imparting skill-based knowledge, upskilling and providing better employment opportunities.”

Why was my manuscript rejected? – Talking about 5 most common reasons for rejection in journals

“We are sorry to inform you that your submission is rejected”- This is something you never want to hear or read but this is most often experienced. These words are disheartening. When we start research, it becomes a dream to see that work turning into pages of a journal. But after so much hard work and research what is something that we lack? This blog will unlock your mysteries and let you know the reasons behind that NO, that rejection. Let’s find out what goes wrong and what one should do.

  1. Technical Screening turning into a failure

The first problem can be in your basic check. From plagiarism to figures, something has gone wrong. In technical Screening, manuscript is rejected if: –

  • There is some issue with language
  • Imprecise hypothesis  
  • Main titles, references, list of authors etc. crucial elements are missing
  • There is no proper conclusion
  • Flaws in study design

2. Deviation from aim and outlook of journal

The biggest and smallest mistake we can do is not finding the perfect journal. Before sending your submission, one must know what the aim and scope of the journal is. If your manuscript is not adding any value to the journal, they will reject it. To learn how to find where to publish and how to find that right key visit https://lnkd.in/drKKnPHe

3. Do not Put your feet in two boats

Journals usually mention that if your work is under review at some other place then they will not consider it. So, do not submit your work at two journals, you might sink. Find the journal interested in your research and focus in one direction.

4. Format it before sending

Journals have their own writing style, their way of transforming the manuscript. It begins from font size, font style and can never end because definitive amount of margin is also essential for a journal. So, it is especially important to meet the standards set by a journal and follow the instructions about guidelines.

5. Finding Originality and Significance

If your submission is extension or another version of some research paper, you have high chances of getting a NO. If the journal does not find any significance in what you are trying to convey then also your submission is rejected.

Take Away Points

For the buds of researching world, it is challenging to get their manuscript accepted. But if you know the secrets and tips to the road, this world is welcoming. The world of publishing and medical writing is a place where you need to know what, why and where. Planning matters here.

To turn the “NO” into “YES”, Turacoz is conducting a webinar on Publishing Planning, and this is your chance to track https://lnkd.in/drKKnPHe

References:

  1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3035881/
  2. https://www.elsevier.com/connect/8-reasons-i-rejected-your-article

Eight Ways to Improve Clarity in Medical Writing

Introduction to Medical Writing

Medical writing involves producing clear, precise documents of high quality to effectively communicate scientific, medical, and clinical data to a wide range of target audiences. It also includes regulatory writing and medical communications.  With the constant advancements in clinical research, large amounts of data must be translated to target audiences such as regulatory authorities, healthcare professionals, patients, and the general public in a clear, explicit, and well-structured format. Apart from thorough technical knowledge, a medical writer must have excellent writing skills to convey complex scientific information credibly and clearly.

Types of Medical Writing

Clarity in Medical Writing

Clarity is the most valued quality required in medical writing to ensure that the audience perceives correct information without any ambiguity. Lack of clarity is the major issue affecting timely submission of research/regulatory documents, publication acceptance rate, and, accessibility of scientific information to health care providers and patients.

Eight Ways to Improve Clarity in Medical Writing:

  1. Clear and Concise Language:
    • Writing in clear language makes a document easy to understand and increases readability.   It is advisable to use simple words to convey accurate information; using sophisticated words often results in confusion and misinterpretation of data. The best practice is to write simple, short sentences containing one idea per sentence for easy interpretation and keeping it concise by using fewer words to communicate necessary information without eliminating any important data.
  2. Avoid Jargons:
    • Using jargon may hinder effective communication especially when the target audience are non-experts in the field of interest. Though experts like scientists or health care providers are aware of medical jargons, it is always recommended to use simpler words and phrases for better communication.
    • When writing for non-experts such as the general public, it is best to avoid jargons completely. For example, writing ‘fast heart rate’ instead of tachycardia, ‘muscle pain’ instead of myalgia, makes it easier to understand.
  3. Avoid Redundancy:
    • Contrary to the assumption that using more words enhances clarity, it may in fact distract the reader from the original idea. It merely adds length to the document without providing any additional information. Do not repeat information that is already presented in the form of tables and figures. This can be achieved by limiting the overuse of synonyms, double negatives, and intensifiers.
  4. Know your Audience:
    • A medical writer offers services to a diverse range of audiences including clinical and regulatory authorities, physicians, patients, and general public. For effective communication, the scientific content has to be tailored according to the target audience. Even cutting-edge research would not leave an impact on the industry experts if it is not documented to suit their level of comprehension. Similarly, when writing for non-experts, the use of plain language is advised to enhance accessibility. Graphical presentation or images can be considered as a good option to convey complex information in a simpler way.
  5. Active over Passive Voice:
    • Medical writers are encouraged to write in active voice for clarity. It helps to present data in a simple, straightforward, and concise manner.
  6. Grammar and Spellings:
    • Good grammar is instrumental to clear and effective medical writing. Grammatically accurate paper conveys precise meaning and in turn keeps the audience engaged. Proper use of punctuations, hyphens, commas aids facilitate comprehensive communication. Similarly, avoiding spelling mistakes helps decipher the right information; a single error in spelling may change the entire meaning of the sentence. A common challenge experienced is with homophones (words with same pronunciation but different meaning); one needs to be vigilant to avoid misinterpretations.
    • It is also important to consider whether to write in British English or US English depending on the target audience and maintain consistency throughout the document.
  7. Formatting:
    • A well written report without proper formatting appears misconstructed. Often standard documents are required to comply with specific regulatory formats. Implementing client specific formatting guidelines aids in improving clarity thereby increasing the level of acceptance.
  8. Proofreading:
    • Once the document is written, proofreading the entire work is extremely critical to check for any inconsistencies or errors in spelling, grammar, abbreviations, capitalizations, and formatting. This step significantly aids in the dissemination of clear, accurate scientific information.

Conclusion

Medical writers play a crucial role in knowledge transfer among scientists, industry experts, healthcare providers, and the public. Accurate interpretation of sophisticated data is essential for good understanding. Articulating well-structured, precise documents can be achieved by implementing various techniques for improving clarity in medical writing.

Medical Writer: Trusted Partner for Medical Affairs Webinar

To get more detailed insights about Medical Writing, we encourage you to register for our upcoming live webinar on 8th January 2022: Webinar Registration Fee (razorpay.com).

Role of a Medical Writer in Publication Documents

Background

Writing is a medium of human communication to express one’s thinking in easily understandable but effective way. The strength of writing is displayed by its knowledge-transforming effects. Knowledge is vital at every stage of research-based endeavours in basic research, clinical research, drug development lifecycle, drug approvals, phases of clinical trials, and post-marketing research.  At each stage, this knowledge is passed on in writing to communicate the findings of research to the scientific community, clinicians, regulators as well as public.

Importance of publication

Publishing biomedical research, in the form of case reports, original articles, literature reviews etc. in peer-reviewed journals, is important. Doing so, augments understanding of health, diseases and their management, drug risks and benefits, and helps to improve medical practice benefitting the patients, health community and society at large.

Reasons to not publish

However, despite the fact that most clinicians and researchers understand the need to publish their work, this task may prove challenging to them because of various reasons including lack of time to write and submit, inadequate data analysis support and technical writing expertise, and lack of knowledge of publication practices and guidelines (1).  But, we all understand and admit that scientific information can be difficult to read and to comprehend. A poorly written information could easily confuse the reader and leave the audience misinformed. For these reasons, numerous papers are rejected by top peer-reviewed journals.

Medical Writing services

Medical writing is communication of scientific and clinical information in a clear, accurate, unbiased, and logical way to a specific set of target audiences such as clinicians, healthcare professionals, regulators, scientists, patients, and general public. This includes the preparation of different types of documents: Regulatory (e.g. clinical trial protocols, clinical study reports, investigator’s brochures, new drug applications, research proposals, informed consent documents); Publications (e.g. original articles, literature reviews, case reports, editorials, abstracts for conferences); Medical education (e.g. posters, continuing medical education (CME), e-learning modules, slide decks for meetings, brochures and internet content for physicians and patients); and Medico-marketing (e.g. literature for product promotion) (5).

Medical Writing – need and demand

There’s pressing need for effective presentation and dissemination of knowledge to accelerate publishing and decision-making in healthcare. Supporting this, a Portuguese report highlighted the importance of medical writing skills for successful publishing in top-rated journals (2). Furthermore, according to a report, global demand for medical writing market was valued at approximately USD 2.03 billion in 2018 and is expected to generate a revenue of around USD 2.95 billion by the end of 2025 (3). Even in India, the medical writing industry is on an upward growth path (4).

Medical Writer – skills and role in publication

Researchers and clinicians may be best at their jobs, but they may not necessarily have the skills to present their data in an effective manner. A medical writer (MW) is a scientific writing and editing expert with an advanced degree in biomedical sciences (e.g. MBBS, PhD) and robust understanding of biomedical and clinical research, reporting guidelines and publication practices such as ICH, ICJME, GPPs, CONSORT (6). He/she would possess substantial data analysis skills to be able to summarise and present even the most complex clinical research data in a coherent manner. This helps the researchers to achieve objectives such as getting their work published in a respected journal, receiving funding for research projects or finding acceptance of their work by their professional peers.

Therefore, the documents prepared with the support of medical writers are less likely to get rejected or retracted by the peer-reviewed journals as they adhere to the reporting and publication guidelines specified by the journals. Such documents are accepted for publication quickly as good writing fastens the review process as compared to the ones without any such support (7). All this suggests that a MW makes a substantial contribution towards a good quality research publication. In addition to providing writing assistance, a MW advise on the right journals for an article and offer support for editing, journal styling and submitting the manuscript for publication (Figure 1).

A MW has the ability to model his/her writing in terms of most suitable language and level of technical information depending on the target audience. For instance, the documents entitled for medical professionals usually include detailed clinical information or data while the ones intended for common people are in simple language and free of core scientific details. In regulatory writing, a MW is well aware of the prescribed formats and regulatory guidelines to be strictly followed in order to produce the high-quality documents.

MWs are not involved in the conception, design or execution of clinical research, so they are not listed as authors, but their contributions are mentioned in the acknowledgments section of the manuscript (8).

Conclusion

Clear, logical, and accurate writing reinforces the dissemination of reliable research information through good quality publications to varied target audience. MWs play an important role to speed up the publication process to meet the growing need for high-quality, timely publications. Clear understanding of the role of a medical writer in publication development will pave the way for their appropriate use by clinicians and scientists to communicate their research findings to the scientific community.

The Medical Writers at Turacoz Healthcare Solutions (THS) understand and abide by the reporting guidelines and publication practices such as ICH, ICJME, GPPs, CONSORT to deliver high-quality documents communicating scientific and clinical information. Turacoz is a medical communications company, which offers services to healthcare professionals in clinical research, regulatory writing, publication writing, medico-marketing writing, and support for conducting medical advisory board meetings.

If you have any queries, email us at [email protected].

References

  1. Sharma S. Professional medical writing support: The need of the day. Perspectives in clinical research 2018; 9:111-112.
  2. Marinho RT, Donato H, Fernandez-Llimos F, Massano J, Silva JM, Almeida M, et al. Think Tank: Relatório estratégico sobre publicação científica biomédica em Portugal. Acta Med Port. 2014;27:1-3.
  3. Global Industry Perspective, Comprehensive Analysis and Forecast, 2019 – 2025. Available from: https://www.zionmarketresearch.com/report/medical-writing-market. Accessed on 15 July 2020.
  4. Shirke S. Medical writing on an accelerated path in India. Perspect Clin Res. 2015;6:125-128.
  5. Bissau J, Borrego P. Professional medical writing: A tool for high quality publications. Acta Med Port. 2015;28:545–7.
  6. Das N, Das S. Hiring a professional medical writer: is it equivalent to ghostwriting? Biochem Med. 2014;24:19-24.
  7. Wager E, Woolley K, Adshead V, Cairns A, Fullam J, Gonzalez J, et al. Awareness and enforcement of guidelines for publishing industry-sponsored medical research among publication professionals: the Global Publication Survey. BMJ Open. 2014;4:e004780.
  8. Angela Stocks, Donna Simcoe, Dikran Toroser & Lisa DeTora. Substantial contribution and accountability: best authorship practices for medical writers in biomedical publications. Current Medical Research and Opinion 2018;34:1163-1168.

Good Practices for Conference Abstracts and Presentation

Medicine is an ever-changing science. As new researches and clinical experience broaden our knowledge, changes in treatment, and drug therapy help in improvising patient care management. WHO describes research as being an imperative element for settling public health challenges – whether it be combating the diseases highly prevalent in developing countries, responding to the alarming rise of chronic conditions, or ensuring proper prenatal, natal and post-natal care for women and children. Research is a structured evaluation to present the facts and reach new conclusions. Medical and scientific conferences serve as a platform for research sponsored by various organizations. These conferences are of crucial importance to disclose and discuss potentially practice-changing data of on-going research studies. The variation in the practices of different organizations makes it difficult to adhere to the good publication practice guidelines and conference requirements. There are no specific guidelines or recommendations to describe the standards for conference presentations.

Company-Sponsored Research

The company-sponsored research is presented in the conferences in the form of abstracts and posters. The scientific committee of the conference review the abstracts. However, they are not included in the peer-review process, as are the journal articles. Further, reviewing the poster and oral presentations is rare. A systematic review reported < 50% were published in full, following presentation at a conference after being accepted as abstracts. It is of utmost importance to attain a high standard process for developing conference abstracts and presentations, mainly for company-sponsored research, since it may ultimately become the only source for a particular analysis. The Good Publication Practices (GPP), Consolidated Standards of Reporting Trials (CONSORT), and Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and recommendations are followed for the conference presentations. On the other hand, the International Committee of Medical Journal Editors (ICMJE), the most widely cited recommendations on authorship, is related exclusively to the publications in peer-reviewed journals. It is challenging to implement these guidelines in practice since they are not fully applicable to conference presentations.

Principles of Good Publication Practice for Company-Sponsored Medical Research

As per GPP guidelines, Good practice for conference abstract and presentation focuses on the presentation of all company-sponsored researches. GPCAP aims to provide guidance on good submission and presentation practice for scientific and medical congresses, explicitly addressing certain aspects where current publication guidelines are inadequate.

Some of the principles for practicing good publication are as follows

  • Ensure timely submissions of the study report guaranteeing complete transparency and accuracy.
  • Reporting and publication processes should follow the FDA, ICMJE, and EQUATOR guidelines.
  • Ethical guidelines should be followed to deliver originality in the abstract and avoiding redundancy.
  • The authorship, contributors (including the writing support), and the sponsorship should be mentioned clearly, ideally at the start of the research, and, in all cases, before publication preparation begins.
  • All the authors should have access to study data and other information; all named authors should review, approve the content of abstracts and presentations, and should take responsibility while being involved in the process of publication.
  • All authors and contributors should disclose any relationships or potential competing interests relating to the research and its publication or presentation.
  • The registration number of the study should be mentioned.

Recommendations for conference organizers

Conference organizers should:

  • Encourage and support the inclusion of contributor lists on posters and slides
  • Include the space for the trial registration number, medical writing support disclosure, sponsor details on abstract forms
  • Use Open Researcher and Contributor ID (ORCID) to uniquely identify scientific and other academic authors and contributors.

Encore Abstract

An encore abstract is typically defined as presenting the same study reports at different conferences to reach various audiences. Even though encore abstracts are not considered to be a superfluous presentation, some conferences accept only the additional findings that were not presented in any other scientific meetings. Presenting the same study to different conferences, the authors and the company sponsoring the research should consider submitting different parts of the studies to reach different audiences at various conferences. It should be noted, the addition of new data to a previously accepted abstract may not necessarily constitute a new abstract unless it is confirmed with the conference.

Encore Checklist

  • Ensure there is no overlapping in terms of the region, profession, etc.
  • Make sure there is no licensing difference between the two regions for the product/medicine of the study.
  • Ensure timely publication of the study even with multiple presentations.

Conclusion

Good publication practices are essential elements and the growing need for on-going and evolving researches in the field of medicine. The authorities and the committees around the world have put together the recommendations and guidelines for improving the accuracy and originality of the study presentations while decreasing the incidence of unethical writing practices; thus, preserving the authenticity of the study. Hence, following appropriate recommendations and guidelines can be helpful in putting forward the research in an effective manner.

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Pharmacovigilance

The term ‘pharmacovigilance’ was coined in the mid 70’s by a group of French pharmacologists and toxicologists to describe the operations encouraging evaluation of the risks and side effects potentially associated with drug treatment.(1, 2)The World Health Organization (WHO) defines pharmacovigilance as, ‘the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem’(3) It incorporates the processes involved in monitoring and evaluating adverse drug reactions viz., collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological products, blood products, herbals, vaccines, medical device, traditional and complementary medicines, with an aim to identifynew information about hazards and figuring out ways to safeguard patients from any potential harm.(2, 4)

Pharmacovigilance aims to:

    • Improve patient care and safety in relation to the use of medicines
    • Improve public health and safety in relation to the use of medicines;
    • Detect problems related to the use of medicines and communicate the findings in a timely manner.
    • Contribute to the assessment of benefit, harm, effectiveness and risk of medicines, leading to the prevention of harm and maximization of benefit.
    • Encourage the safe, rational and more effective use of medicines.
    • Promote understanding, education and clinical training in pharmacovigilance and its effective communication to the public(5)

Pharmacovigilance Setup
A typical setup for pharmacovigilance studies includes people from various organizational units, people at various levels colluding to prevent drug related problems and thereby decreasing morbidity/ mortality rates. Figure 1 depicts the various functions of each party involved in a pharmacovigilance setup.(2)


Operational Overview
The process of pharmacovigilance begins with safety information coming in fromvarious sources, followed by processing and assessment of these reports to their relationship with the investigational product, and submission of the compiled report to the concerned regulatory authorities.Figure 2 summarizes the major activities associated with pharmacovigilance.(6)


Type of Data Collected
According to the, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guideline E2D, two types of safety reports are distinguished in the post-authorization phase, viz.,
a) Unsolicited Reports
b) Solicited Reports
Table 1 enlists the types of reports included in both the categories.(7)Table 1: Classification of Safety Reports [Adapted from: Good Pharmacovigilance Guideline Module VI (7)]

Data Collection Methods
The process of data collection in a pharmacovigilance setup is broadly of 3 types:
1.Passive data collection
2.Mandatory data collection
3.Active data collection

1.Passive Data Collection
Passive data collection also known as voluntary case reporting, involves active participation by health care providers in reporting adverse reactions and medication errors.

2. Mandatory data collection
Mandatory data collection is when manufacturers and pharmaceuticals must report information on adverse reactions gathered during post-marketing surveillance to the health authorities as per the country regulations.

3. Active data collection
Active data collection is a focused and structured data collection activity involving use of various tools such as trigger tools, patient chart audits, and direct observation methods.(8)

Data Collection Tools
Adverse drug reactions and medication errors are generally collected by filling a standardized form. For countries with a national pharmacovigilance program (e.g., India), the reporting forms are generalized throughout thecountry.(8) These are collected in different databases. For example, Adverse Event Reporting System (AERS), Eudravigilance, Vigiflow, etc.(9)
Figure 3 provides a country-wise list of database and adverse drug report forms.


Figure 3: Country-Wise Database and Adverse Drug Report Forms [Adapted from: Kumar A. et al.,(9)]
Data MiningData mining is the process of searching big data sets for interesting or useful information.(10) Data mining is used in the construction of literature-extracted knowledge databases as well as a method for detecting new potential drug interactions. Information retrieval and natural language processing (NLP) techniques are frequently used in data mining. (11)It also provides an “early warning system” to help identify drug safety issues. (12)
Many methods have been developed for data mining drug safety signals (early hints suggesting the possibility of adverse events) in pharmacovigilance, such as disproportionality analyses, text mining, natural language processing, change-point analysis, geographical information systems technology, visualization tools, etc.(13, 14)The most common of them are viz.,

a)Disproportionality Analyses
b)Text Mining(12)
a)Disproportionality Analyses

Disproportionality analyses is primarily used for data mining spontaneous reporting system (SRS) databases. It makes use of statistical methods such as, proportional reporting ratio (PRR) and multi-item gamma poisson shrinker (MGPS) to compare the observed count of a drug-adverse event combination with a background count for the adverse events for all other drugs or drug combinations in the database. (12, 14) Several software programs generate PRR and/or MGPS scores such as Empirica Signal™, PV-Analyser™, Molecular Analysis of Side Effects [MASE™], Empirica Study™, JReview™, and Statistical Analysis Systems (SAS™). (14)
b)Text Mining
The large volume of “unstructured” or “narrative” data submitted in the reports such as event descriptions or narratives in electronic health records, medical literature, social media, or the internet, require analysis with the help of ‘text mining’.(12)Vaccine Adverse Event Text Mining (VaeTM) system, search and retrieval framework (SARF), Linguamatics™ I2E, Georgetown Vaccine Information and Safety Resource (G-VISR) tool, MedWatcher Social, SAS Enterprise Miner™, etc., are the various tools used to perform text mining. (14)
Figure 4 describes the data mining methods used for different types of data.


Figure 4: Data Mining Tool for Different Types of Data[Adapted from: DuggiralaHJ. et al., (14)]New Trends in Pharmacovigilance
The current trends followed in the pharmacovigilance industry are elaborated below;

  • Contract outsourcing to increase operational efficiency
  • Use of secondary data sources that contribute to widespread adverse drug reaction reporting
  • Cloud-based reporting to bring a robust global database of adverse drug reactions accessible to all
  • Big data technologies to protect and assimilate huge amounts of information
  • Use of data analytics to improve data utilization
  • Automation in the pharmacovigilance process to increaselabor efficiency
  • Artificial intelligence to overcome the drawbacks with traditionalpharmacovigilance services

Social Media and Pharmacovigilance
The Internet and social media has changed people’s mindset in relation to health care. According to the Pew Research Center’s Internet & American Life Project 2013, 72% of internet users admitted looking online for health information of some kind. (15) Social networks, forums and blogs have become a major platform for patients to share their therapy experiences, including adverse drug reactions. (16) Reports from social media sources are much rapid, occurring in close proximity to the event and are potentially richer sources than those reported through healthcare professionals. (17)
Figure 5 describes the ways in which pharmacovigilance teams can use social media to participate and enhance product safetyawareness.


HCP, Health Care Professional; PV, Pharmacovigilance.
Figure 5: Use of Social Media to Engage and Improve Awareness About Product Safety[Adapted from: The Impact and Use of Social Media in Pharmacovigilance (17)]The ICH-GVP, Council for International Organizations of Medical Sciences (CIOMS) Guidelines and the US FDA Guidelines provide guidance to the pharmaceutical industry for development and implementation of their social media strategies for pharmacovigilance. (7, 18, 19).Benefits of social media in pharmacovigilance are listed below (Figure 6).

HCP, Health Care Professional.
Figure 6: Benefits of Social Media on Pharmacovigilance[Adapted from: The Impact and Use of Social Media in Pharmacovigilance (17)]

Conclusion
Pharmacovigilance is an important discipline in managing adverse reactions of healthcare products.(20) It is based on the qualitative and quantitative research of reports of spontaneous adverse drug reactions, followed by a clinical evaluation of its effect on the drug’s general safety profile. Pharmacovigilance can promote public health programs by offering continuing information throughout the life cycle of a product, enabling a precise, reliable and balanced evaluation of the product’s risk-benefit ratio as more and more information becomes accessible with its use. (21) Pharmacovigilance’s fundamental goal is the secure use of drugs, safety of patients, and the protection of public health. To achieve this goal, national regulators and international organizations should be empowered to report more adverse reactions to health care professionals and the public.

References
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17.The Impact and Use of Social Media in Pharmacovigilance2018. Available from: https://www.sciformix.com/wp-content/uploads/Social_Media_in_PV_Whitepaper.pdf.
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