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Drug Discovery
and Clinical
Research
SK Gupta

Essentials Of Medical
CHAPTER 15
Writing
 CHAPTER
TOC 1: New Drug Development
Index 
 CHAPTER 2: Drug Discovery And Developmen
Of Biologics
 CHAPTER 3: Clinical Development Of New
Drugs  
 CHAPTER 4: Phase 0 Trials In Cancer Drug
Development
INTRODUCTION
 CHAPTER 5: Bioethics In Clinical Research
 CHAPTER 6: Medical Devices—Regulations
And Research The health sector has gone through an enormous change during the last
 CHAPTER 7: Clinical Development Of Vaccines decade with people getting more aware and conscious about their health. The
 CHAPTER 8: Clinical Development Of online searches have contributed tremendously towards the health awareness.
Anticancer Molecules
The patient started exploring about the information related to different diseases
 CHAPTER 9: Role Of Pharmacovigilance In
Clinical Research and their treatment through the internet and became well versed with the
 CHAPTER 10: Data Management In indications and contraindications of the drugs compelling the pharma
companies to search for new molecules. Growing demands of the people for
different healthcare products such as pharmaceuticals, alternate medicines,

neutraceuticals, special nutritional supplements, cosmetics, and herbal
products have intensi ed the competition between various national and
multinational companies who boast about their health care products through
massive campaigns. A sudden boom in advertisements, promotional materials
for marketing, and materials for creating awareness amongst the health care
professionals as well as the patients using print or other media has occurred.
All these have resulted in the need of well structured documents that spread the
information clearly and concisely to the targeted audience by the
pharmaceutical industry. This eventually has led in the growing demand of
specialized writers who can very well collaborate with pharma companies,
patients, health professionals and others involved in this business. These
specialized writers are the medical writers who are not necessarily a doctor or
writer by quali cations. The growing need of various pharmaceutical products
has accentuated the role of medical writers. Amalgamation of science
knowledge, research skills, air for writing with the understanding of the
audience makes one a successful medical writer.
 

FUNDAMENTALS OF GOOD MEDICAL WRITING

GOAL

Medical writing includes various forms of publications like original publications,

reviews, short communications, documents for regulatory approval, marketing
collaterals, web contents, etc. for different target audiences. Therefore, with
such varied users and audiences the medical writer should de ne the goals and 402
key objectives to produce a speci c, concise and enthralling material. The writer
should aim to represent the research of scientists and health care professionals
as accurately as possible, amuse his readers by imparting knowledge and
awareness. Complex scienti c material should be made simpler, graspable and
interesting targeting public-oriented communities.
 

OPPORTUNITIES
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The medical writers have opportunities in scienti c and nonscienti c areas.

Writers having high degree in science and allied subjects excel in scienti c
communications in contrary to writers with high degrees in language who excel
Drug Discovery in nonscienti c or marketing communications.
and Clinical
Research 1. Scienti c medical writing includes preparing manuscripts of the research
SK Gupta outcomes for the journals, abstracts, full length research articles, short
communications, review articles, letters to editor, monographs, presentations,
posters, editing and reviewing scienti c articles, CD-ROMs, web pages,
medical education materials, regulatory documents and white papers.
2. Job opportunities for such writers lie with clinical research organizations
 CHAPTER
TOC 1: New Drug Development
Index  (CROs), hospitals, academic institutions, pharmaceutical companies,
 CHAPTER 2: Drug Discovery And Developmen
Of Biologics publishers, websites, regulatory agencies, medical educational centers or
 CHAPTER 3: Clinical Development Of New societies, etc. CROs conduct clinical trials for the pharmaceutical companies
Drugs
so that the products can be registered with the national /international
 CHAPTER 4: Phase 0 Trials In Cancer Drug
Development regulatory authorities. The approval processes are quite cumbersome and
 CHAPTER 5: Bioethics In Clinical Research time consuming. The documents to be submitted to the regulatory
 CHAPTER 6: Medical Devices—Regulations authorities should be well written to avoid further delay. Therefore, the
And Research
medical writer in a CRO has responsibilities of preparing study protocols,
 CHAPTER 7: Clinical Development Of Vaccines
investigator brochures, study reports and several papers which are to be
 CHAPTER 8: Clinical Development Of
Anticancer Molecules submitted to the regulatory authorities. However, marketing medical writing
 CHAPTER 9: Role Of Pharmacovigilance In includes promotional pamphlets, brochures, advertisements, posters, sales
Clinical Research
training manuals, etc. The prospective clients and employers of the
 CHAPTER 10: Data Management In
marketing medical writers could be medical advertising or communication
agencies, pharmaceutical companies, publishers, websites, hospitals,
 academic medical centers, associations, foundations, etc.
3. Persons who have the initiative and air for writing, with working knowledge
of human anatomy, and wish to work in exible hours can become freelance
writers. One can be a fulltime freelance writer or a part-time writer earning
while learning, sharing other responsibilities at home or even after retirement.
A freelance writer can write in different formats and styles for varied
audiences. The person can choose from being a research writer, translator,
proofreader, copy editor, reviewer, ghost writer, webcontent writer, etc.
Becoming a freelance writer needs motivation and work organization. The
personal and life should not be intermingled or else there will be a great 403
mess. A clear line should be drawn between personal and professional time
so that even while working from home a professional attitude is maintained.
The writer should be able to build up contacts and generate regular work.
Strict timelines should be followed while writing a document or else the
person looses its credibility.

CHARACTERISTICS

Thorough research, accuracy, logical organization, clear thinking and writing,

and readability are the main characters of the good medical writing. A good
medical writer delves into the subject he is going to write about, he does a
thorough research in the subject so that the information he is about to provide
is accurate. All information gathered should be organized and written in a
coherent manner so that it can be logically understood by the audience he
intends to write for. The writing should be such that the reader becomes more
interested in the matter as he moves further with the reading.
 

THE WRITER'S ROLE

The medical writer's role is important in the sense that he has to plan and
produce scienti c/medical quality content in a speci c discipline or various
therapeutic areas. To accomplish this, interaction with the clients and the staff
he is working with, is needed. He should be very good in communicating with

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his colleagues or with people from other disciplines to gather information.

Writing a document not only requires gathering of specialized information but
attention to details should also be given utmost importance. Paying attention to
Drug Discovery small things and attending to the details earnestly helps in improving the quality
and Clinical of the end result. The responsibility of the nished scienti c or medical content
Research
lies with the medical writer.
SK Gupta
 

ASSESSING THE AUDIENCE

It is very important to know who are the readers; unless it is assessed, a good
 CHAPTER
TOC 1: New Drug Development
Index  presentation of the writing cannot be made. The writer should rst assess the
 CHAPTER 2: Drug Discovery And Developmen
Of Biologics level of experience or knowledge of the audience, writing for general public will
 CHAPTER 3: Clinical Development Of New be de nitely different from the writing meant for highly professional audience.
Drugs
The terminologies used in the write-up vary accordingly. Selecting highly
 CHAPTER 4: Phase 0 Trials In Cancer Drug
Development technical terms is not appropriate for general audience; the terms used should
 CHAPTER 5: Bioethics In Clinical Research be simple or may be elaborated or explained. The background information
 CHAPTER 6: Medical Devices—Regulations should be included according to the level of the audience; it should be very clear
And Research
to the author who is the audience and what is the purpose of the audience to go
 CHAPTER 7: Clinical Development Of Vaccines
through the document. One should also keep in mind that whether the
 CHAPTER 8: Clinical Development Of
Anticancer Molecules document prepared is informative and meant for the general public or for
 CHAPTER 9: Role Of Pharmacovigilance In convincing a more professional audience. The writer should also consider that
Clinical Research
whether the audience would read the document as narrative or read it in
 CHAPTER 10: Data Management In
sections. 404
 

TAKE HOME POINTS

The document prepared should have a clear take home message. The article
can be summed up giving a brief description of the research and its results, the
controversies arising from it or the lacuna in the research, and nally, what the
author expects from the reader to do with this new piece of information.
 

TYPES OF MEDICAL WRITING

The writer should choose the eld he wants to write for. Medical writing can be
scienti c or promotional marketing writing. The scienti c medical writing for
the pharmaceutical industry can further be categorized as follows.
 

REGULATORY MEDICAL WRITING

Various rules and regulations have been imposed for drug development and its
marketing for the bene t of people. Need for well written documents for
regulatory submission becomes essential for the pharmaceutical companies or
clinical research organizations so that they can pass through the scrutinizing
eyes of the reviewers without being rejected. Since the approval process is quite
cumbersome and time consuming, the companies are compeled to hire trained
persons for preparing the documents that comply with regulatory, journal, or
other guidelines in terms of content, format and structure to avoid unnecessary
delay. The regulatory writing also known as clinical research writing includes
the preparation of documents required by the regulatory agencies for the
approval process for drugs, devices and biologics. Clinical trial protocols,
informed consent forms, patient information sheets, investigator's brochure,
interim/study completion reports, new drug applications (NDA) are examples of
such documents and their preparation requires a sound knowledge of current
and emerging regulatory requirements or guidelines.
 

EDUCATIONAL MEDICAL WRITING

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It consists of documents written for general audiences, students or healthcare

professionals such as doctors, nurses, pharmacists, etc. Educational writing
can be further categorized into the following.
Drug Discovery  
and Clinical
Research SCIENTIFIC WRITING
SK Gupta

It is presenting the information gathered by consulting libraries, reading books,

attending educational institutions or conducting research in a concise, simple,
logical and organized way.

 CHAPTER
TOC 1: New Drug Development
Index  Original research articles, reviews, letters to the editors, short
 CHAPTER 2: Drug Discovery And Developmen 405
communications, editorials, poster or powerpoint presentations for the
Of Biologics
 CHAPTER 3: Clinical Development Of New
conferences or the meetings, study modules for the various courses or
Drugs continuing medical education fall in this category. The audience for scienti c
 CHAPTER 4: Phase 0 Trials In Cancer Drug writing is highly specialized.
Development
 
 CHAPTER 5: Bioethics In Clinical Research
 CHAPTER 6: Medical Devices—Regulations
And Research CONSUMER HEALTH WRITING
 CHAPTER 7: Clinical Development Of Vaccines
 CHAPTER 8: Clinical Development Of People are becoming aware about their health and are eager to get information
Anticancer Molecules
related to various types of diseases, how they are caused, what are the risk
 CHAPTER 9: Role Of Pharmacovigilance In
Clinical Research
factors, latest treatment available, is there any side effect of the prescribed
 CHAPTER 10: Data Management In drug, or is there any alternate medicine. All these information is gathered either
from the books, magazines or Web. Reviews of clinical trials or research studies
help in disseminating information to the patients or general public. Feature
 articles on a new disease, new treatment or device interests the readers. All
information related to health improvement whether it is a medicine, device,
lifestyle modi cations reach to the consumers through health magazines,
dictionaries, encyclopedias, newspapers, advertisements, blogs and websites.
 

MEDICOMARKETING WRITING

It is crucial for the nancial growth of any pharmaceutical industry. Production

of marketing collaterals such as sales brochures, instrument manuals,
demonstration advertisements, web contents, posters, etc. of new health
products, be it a drug or a medical instrument or device, meant for the
healthcare professionals has enhanced the opportunities of medical writers in
the pharma sector.
 

TYPES OF RESEARCH PUBLICATIONS

ORIGINAL ARTICLES

The publications in which the authors/researchers detail their research

methods, and discuss the results and its possible implications. These articles
can be published in peer reviewed journals of the concerned eld. Such
publications have a very specialized audience like students (mostly of a
particular discipline), researchers or professionals.
 

REVIEW ARTICLES

Reviews are not original publications instead they are a coherent narrative of
the information gathered from a collection of articles on a single topic. They
give comprehensive information about the work conducted in the particular
eld and also provide journal references to the original research. These are
published in many journals or books. 406
 
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SHORT PAPERS

Drug Discovery These are original research articles meant for publishing in journals,
and Clinical proceedings, etc. The length of these articles is comparative less than the full
Research length paper.
SK Gupta  

CASE REPORTS

Any novel or unusual episode or incidence is usually described in case reports.

 CHAPTER
TOC 1: New Drug Development
Index  A case report of a patient is a detailed report describing symptoms, signs,
 CHAPTER 2: Drug Discovery And Developmen
Of Biologics diagnosis, treatment and follow-up. Demographic pro le of the patient may also
 CHAPTER 3: Clinical Development Of New be included in it. These are published by some of the medical journals. Certain
Drugs
journals exclusively publish case reports like Journal of Medical Case Reports.
 CHAPTER 4: Phase 0 Trials In Cancer Drug
Development
 
 CHAPTER 5: Bioethics In Clinical Research
 CHAPTER 6: Medical Devices—Regulations EDITORIAL
And Research
 CHAPTER 7: Clinical Development Of Vaccines It is the article which gives the opinion of the editor of a periodical on a current
 CHAPTER 8: Clinical Development Of
topic or issue re ecting the opinion of the periodical. The editorials are
Anticancer Molecules
 CHAPTER 9: Role Of Pharmacovigilance In
published mostly in newspapers and magazines with a wide audience.
Clinical Research  
 CHAPTER 10: Data Management In
LETTERS
 A short communication containing outcomes of original research can be sent to
the journals for faster publication as they are thought to be urgent.
 

SPECIAL PUBLICATIONS

Proceedings of the conferences, monographs, transactions of meetings of the

members of societies or publications related to a particular topic come under
this category.
 

REQUIREMENTS FOR WRITING RESEARCH ARTICLES

Any advancement in the eld of science or medical science should be

communicated to the public in order to enrich their knowledge. It is the
obligation of the researchers to publish their work in the reputed journals so
that the people all over the world may be bene ted. To achieve this, the
research outcome should be presented in such a manner that it becomes
graspable and others, if interested, can repeat and see the results. Publication
of a research article needs to ful ll certain requirements of the selected journal.
Most of the journals have almost similar requirements having a title, body and
references. The body of the text can be divided into different sections or
subsections.
 

TITLE

The preferred title of the paper should be short and informative. It should also
clearly identify the general eld as well as the speci c branch under
consideration. 407
 

TITLE PAGE

The title page generally contains the title of the paper, name of the contributors
and their a liations, name, address, phone numbers, email address of the

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corresponding author and a short running title.

 

Drug Discovery ABSTRACT

and Clinical
Research An abstract helps the reader to quickly have an idea about the article contents.
SK Gupta The reader can then decide whether he wants to continue reading or can save
time by switching to other article. Generally every research/review article and
case reports contain a short abstract of usually 200 to 300 words. The abstract
may be unstructured or structured with introduction, aims and objectives,
method, results and conclusions. The abstract brie y describes the objectives,
 CHAPTER
TOC 1: New Drug Development
Index  scope of the investigation and research outcomes. Unnecessary abbreviations,
 CHAPTER 2: Drug Discovery And Developmen
Of Biologics acronyms and references should be avoided. Five to six key words may be given
 CHAPTER 3: Clinical Development Of New at the end of the abstract.
Drugs
 
 CHAPTER 4: Phase 0 Trials In Cancer Drug
Development
 CHAPTER 5: Bioethics In Clinical Research INTRODUCTION
 CHAPTER 6: Medical Devices—Regulations
And Research It contains the statement of the problem on which one is working and related
 CHAPTER 7: Clinical Development Of Vaccines background information. The reader is introduced to the relevant literature and
 CHAPTER 8: Clinical Development Of
Anticancer Molecules
comes to know about the relevance of the current work by a clear statement on
 CHAPTER 9: Role Of Pharmacovigilance In scope and objectives. The introduction can gradually lead to the objectives of
Clinical Research the study so that continuity is maintained.
 CHAPTER 10: Data Management In  

MATERIALS AND METHOD


The methodology and the materials used should be provided to the reader so
that the reader can repeat the work and the results can be reproduced. The
results should be reproducible when scienti cally performed. The details of the
study design should be given along with the techniques used for evaluating the
results. If the technique is new full details should be provided whereas in case
of standard techniques a citation of the journal article should be incorporated.
The detail such as number of replicates used, study duration, temperature,
measurements, amounts, animal species, sex and weight may be given. Results
should not be given with procedure. Details of statistical analysis should not be
given only a brief mention of the method used will su ce the need. Past perfect
tenses are used when writing materials and method.
 

RESULTS

The ndings of the study are described with the help of tables, line diagrams,
gures and images. The results should be clearly explained in a simple manner.
The data should be well explained neither too condensed nor elaborate. 408

The data given in the table should not be repeated. Like materials and
method results should also be written in past perfect tense.
 

DISCUSSION

The results of the study are discussed in this section of the article. Most
important ndings are summarized in the discussion. The conclusions that can
be drawn from the results are given here. Does the ndings support the
hypothesis or not, or the ndings are in accordance with the previously
published articles on the similar problem or there are contradictions, the
plausible explanation should be given for this.
 

CONCLUSION

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This section should indicate major contributions of the paper and what are the
related untouched areas on which researches can be conducted.
 
Drug Discovery
and Clinical ACKNOWLEDGMENT
Research
SK Gupta The author(s) can add a line of acknowledgment for any nancial assistance or
assistance in preparing the manuscript or using any facility, etc.
 

REFERENCES
 CHAPTER 1: New Drug Development
TOC Index 
 CHAPTER 2: Drug Discovery And Developmen
Of Biologics
References to support the research study are cited in the text and are enlisted
 CHAPTER 3: Clinical Development Of New at the end of the paper. The references are written in Harvard or Vancouver style
Drugs depending upon the style of the selected journal. There are different ways of
 CHAPTER 4: Phase 0 Trials In Cancer Drug writing the reference of journals, books or websites. Each journal or book has
Development
their own guidelines. The instruction to authors should be read carefully prior to
 CHAPTER 5: Bioethics In Clinical Research
 CHAPTER 6: Medical Devices—Regulations writing the research article.
And Research  
 CHAPTER 7: Clinical Development Of Vaccines
 CHAPTER 8: Clinical Development Of CAREER OPPORTUNITIES
Anticancer Molecules
 CHAPTER 9: Role Of Pharmacovigilance In
Clinical Research A person gets many opportunities as a medical writer. A writer with the
 CHAPTER 10: Data Management In managerial skills can be involved in the management of team of writers
assigning or undertaking job responsibilities at local or international level or be
engaged in the marketing of the pharmaceutical products. To satiate his
 interest he can choose from various categories of medical writing. He can
become a part of pharmaceutical company, clinical research organizations,
hospitals or health care agencies. If the person has imaginative powers or
creativity he can also be involved in the medical advertising agencies or can be
involved in designing web contents. A person with a strong observation skill can
be a good proofreader and become a part of some publishing house. Editing
and reviewing articles can also be a good option for some. Persons not able to
carry out a full time job due to other responsibilities can be freelance writers
with exible timings and can work from anywhere. They can enjoy variety in
writing while serving for varied clients (Fig. 15.1). 409

Fig. 15.1: Career opportunities for medical writer

 

QUALIFICATIONS AND SKILLS NEEDED

The term medical writer does not mean that the writer is from medical
background. No particular technical training is required to become a medical
writer. A graduate degree in science, medicine, pharmacy, journalism, mass
communication, English or allied elds would su ce. However, the person
should be conversant with the medical terminologies used in preparing varied
type of documents. The most important thing needed is the inclination and air

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for writing. The person should possess a good communication skill so that he
can interact with people of different background and expertise, interview them
and gather information related with their eld or expertise. The person should
Drug Discovery be able to interact with people other than his close associates. The person
and Clinical should possess good writing skills, editing and proof reading skills (common
Research
symbols used for proof reading and editing are given at the end of the chapter),
SK Gupta
knowledge of grammar, know how to search information quickly and above all
he should be able to stick to timelines. The person should be able to meet the
deadlines xed for the article.
 
 CHAPTER
TOC 1: New Drug Development
Index 
 CHAPTER 2: Drug Discovery And Developmen INITIATING THE WRITING CARRIER
Of Biologics
 CHAPTER 3: Clinical Development Of New Starting a carrier in medical writing does not primarily involve a degree in
Drugs
medicine or mass communication. However some training whether informal or
 CHAPTER 4: Phase 0 Trials In Cancer Drug
Development formal helps in moving forward in the eld. 410
 CHAPTER 5: Bioethics In Clinical Research  
 CHAPTER 6: Medical Devices—Regulations
And Research INFORMAL TRAINING
 CHAPTER 7: Clinical Development Of Vaccines
 CHAPTER 8: Clinical Development Of
Anticancer Molecules
There are number of ways to get the informal training to be a medical or
 CHAPTER 9: Role Of Pharmacovigilance In scienti c writer through books, journals, internet, etc. To start with, a medical
Clinical Research writer can take help of many online and o ine resources.
 CHAPTER 10: Data Management In  

ONLINE RESOURCES

1. Several online medical dictionaries available such as Dorland's online
medical dictionary or Stedman's online medical dictionary are wonderful aid
in getting the information related to various diseases or getting familiar with
medical terminologies.
2. Assistance of software can be taken for learning medical terminologies and
spell check. A variety of them are available online for free.
3. A range of online medical and pharmaceutical journals are available for free.
These journals can provide information related to a particular disease, its
pathology, treatment modalities, and recent advances in therapeutics. They
are a very good source for preparing background information for
investigator's brochure or materials for health care professionals or
marketing, etc.
4. Besides, there are lots of free online books available that can assist in
gathering information regarding the subject or the disease selected.
5. The author may need information about the latest drugs used for the medical
therapy of diseases and regulations for the drug trials and marketing. He
should be well acquainted with such regulations. Country wise regulatory
guidelines are available at the site of most of the regulatory authorities.
Some of the regulatory authorities are CDSCO (India), FDA (US), ANVISA
(Brazil), MHRA (UK), WHO, EU (Europe) whose websites are given below.
6. A medical writer also gets aware of the latest happenings in the world of
health care, be it developments in pharmaceutical industry, health care
centers, new regulations imposed on medicines, devices, research, etc. using
online internet services. The writer becomes informed about the new drug
molecules in the pipeline in pharma industry.

Pharmaceutical, Medical And Health-Related Government

And Regulatory Bodies Around The World

International

International Conference on Harmonisation (ICH)

(Http://Www.Ich.Org/)

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World Health Organization (WHO) (Http://Www.Who.Int/En/)

World Trade Organization (WTO) (Http://Www.Wto.Org/)

Drug Discovery Australia

and Clinical
Therapeutic Goods Administration (TGA) (Http://Www.Tga.Gov.Au/)
Research
SK Gupta
Brazil

National Health Surveillance Agency (Anvisa)

(Http://Www.Anvisa.Gov.Br)

 CHAPTER 1: New Drug Development Canada

 CHAPTER 2: Drug Discovery And Developmen
Of Biologics Health Canada (Http://Www.Hc-Sc.Gc.Ca/) 411
 CHAPTER 3: Clinical Development Of New
Drugs China
 CHAPTER 4: Phase 0 Trials In Cancer Drug
Development State Food and Drug Administration (SFDA)
 CHAPTER 5: Bioethics In Clinical Research
(Http://Eng.Sfda.Gov.Cn/Eng/)
 CHAPTER 6: Medical Devices—Regulations
And Research
Europe
 CHAPTER 7: Clinical Development Of Vaccines
 CHAPTER 8: Clinical Development Of EU Legislation—Eudralex (Http://Ec.Europa.Eu)
Anticancer Molecules
European Medicines Agency (EMEA) (Http://Www.Ema.Europa.Eu/)
 CHAPTER 9: Role Of Pharmacovigilance In
Clinical Research
France
 CHAPTER 10: Data Management In

Agence Française de Sécurité Sanitaire des Produits de Santé

 (Http://Www.Afssaps.Fr/)

India

Central Drug Standard Control Organization (CDSCO)

(Http://Www.Cdsco.Nic.In)

Indian Council of Medical Research (ICMR)

(Http://Www.Icmr.Nic.In/)

Ministry of Health and Family Welfare (MoH&FW)

(Http://Www.Mohfw.Nic.In/)

UK

Medicines and Health care Products Regulatory Agency (MHRA)

(Http://Www.Mhra.Gov.Uk)

National Health Service (NHS) (Http://Www.Nhs.Uk)

National Institute for Biological Standards and Control (NIBSC)

(Http://Www.Nibsc.Ac.Uk)

USA

Centers for Disease Control and Prevention (Http://Www.Cdc.Gov/)

The Food and Drug Administration (FDA) (Http://Www.Fda.Gov/)

National Center for Complementary and Alternative Medicine

(NCCAM) (Http://Www.Nccam.Nih.Gov/)

National Institutes of Health (NIH) (Http://Www.Nih.Gov/)

OFFLINE RESOURCES

It is always good to read and grasp the information from different sources. The
more a person reads the better he can reproduce. Books, medical or scienti c
journals/magazines can also be purchased or issued from a public library at a
nominal fee or through membership. Some basic knowledge of the statistics is
also bene cial.
 
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TECHNICAL SKILL

Drug Discovery In addition to the above mentioned resources that contribute in gaining the
and Clinical knowledge about the topic to be taken up for writing, few technical skills are
Research also needed.
SK Gupta
Language: The command over the language in which the documents are being
written is of utmost importance. Since English is the universally accepted
language most of the scienti c literature is written in English. Therefore, writers
having control over English language, grammar and a air for writing have
 CHAPTER 1: New Drug Development
added advantage. A well written document, grammatically correct with
 CHAPTER 2: Drug Discovery And Developmen
Of Biologics appropriate punctuations can clearly communicate the message to the readers
 CHAPTER 3: Clinical Development Of New creating an interest in them to indulge further in reading. 412
Drugs
 CHAPTER 4: Phase 0 Trials In Cancer Drug Computer knowledge: One of the most important requirements for preparing
Development
different types of documents is to improve one's computer skill. A computer
 CHAPTER 5: Bioethics In Clinical Research
savvy writer has added bene ts. He will be more e cient in gathering
 CHAPTER 6: Medical Devices—Regulations
And Research information, preparing computer generated documents, graphics or
 CHAPTER 7: Clinical Development Of Vaccines illustrations. Preparing presentations, posters, materials for market promotion
 CHAPTER 8: Clinical Development Of or for the physicians or even publishing a book becomes easy, dependency on
Anticancer Molecules
others is reduced and lot of time and money is saved.
 CHAPTER 9: Role Of Pharmacovigilance In
Clinical Research  
 CHAPTER 10: Data Management In
FORMAL TRAINING

 Unlike these informal trainings a person can also get formally trained in medical
writing. He can choose appropriate courses and get formally trained in medical
writing. Some of the courses are given below which can be of assistance:

1. A degree in basic science or pharmacology can be pursued if not interested

in studying medicine.
2. A degree in English or mass communication or journalism with working
knowledge of human anatomy and physiology or
3. A course in biostatistics will have additional signi cance.
4. He can opt for a career in medical writing by getting enrolled in medical
writing courses or programs offered by any one of the several organizations.
Details can be found online. AMWA is one such organization that imparts
training in medical writing.

List Of Some Of The Websites Related With Medical Writing

Courses

1. Http://Www.Emwa.Org/Training.Html

2. Http://Iocbindia.Org/Medicalwriting.Htm

3. Http://Www.Infocusrx.Com/Icme/About.Html

4. Http://Www.Infocusrx.Com/Icme/About.Html?Tcsrc=Www.Training-
Classes.Com

5. Http://Www.Emagister.Co.Uk/Medical_writer_courses-
Ec170147415.Htm

6. Http://Www.Aagmedicalwriting.Co.Uk/Medical_writing_training_cour
se.Html

7. Http://Www.Sfep.Org.Uk/Pub/Train/Training.Asp

8. Http://Medicalwritingtraininguk.Co.Uk/

9. Http://Www.Medicalwritingtraining.Com/

10. Http://Www.Cfpie.Com/Showitem.Aspx?Productid=CMWP

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REMUNERATION

Drug Discovery The salary of the medical writer depends upon the quali cations and
and Clinical experience. A medical writer having regular employment can earn between $
Research 65000–85000 annually in USA depending upon the nature of the job, company's
SK Gupta
pro le, etc. Some extraordinary writers can have six digit salaries. On the
contrary, the earning of a freelance writer relies on the number of pages of the
document produced or hours devoted for the writing. 413
 

 CHAPTER 1: New Drug Development

 CHAPTER 2: Drug Discovery And Developmen
TOOLS
Of Biologics
 CHAPTER 3: Clinical Development Of New A good document can be created using variety of tools. These tools assist the
Drugs
writer to create usable information with illustrations and graphics or a web
 CHAPTER 4: Phase 0 Trials In Cancer Drug
Development page. There are no de ned tools which are used by the writers; however some
 CHAPTER 5: Bioethics In Clinical Research of the broadly used basic tools are described below:
 CHAPTER 6: Medical Devices—Regulations  
And Research
 CHAPTER 7: Clinical Development Of Vaccines PUBLISHING TOOLS
 CHAPTER 8: Clinical Development Of
Anticancer Molecules
 CHAPTER 9: Role Of Pharmacovigilance In
These are the basic tools for technical writing that can create a document, edit
Clinical Research and format the text, insert the tables and graphics. A number of word
 CHAPTER 10: Data Management In processors are available, the most commonly used are MS-Word and Adobe
FrameMaker.
 

IMAGE CAPTURING AND GRAPHICS TOOLS

Most of the documents contain graphics and illustrations to make the

information more communicative. The medical writer should possess a basic
knowledge about capturing, editing, creating illustrations. Adobe Photoshop is
the most popular graphics editing program. Besides Illustrator and CS4 (by
Adobe) Corel Draw, SnagIT, are some other graphics tools used by the
technical/medical writers.
 

HELP AUTHORING TOOLS

Many tools like RoboHelp, Flare, Doc To Help are used for producing printable
user manuals and online help les in .htm, .rtf, .chm formats, each having its
own merits and demerits.

Some other help tools include Paper Killer, HelpStudio, Fast-Help, AuthorIt,
Digipedia, Help-Producer, O ceHelp, HTMLHelp Workshop,
 

WEB TOOLS

Designing a web site or a web page requires e cient web tools. Several web
tools are available such as WebTools Pro, Google Web Toolkit (GWT), HTML
editors, search engine tools, GOOGLE tools, YAHOO tools, MSN tools and many
more. Most of the tools can be downloaded for free or trial versions with limited
features.
 

SOFTWARE NEEDED

Basic software required by a medical writer includes following:

A web browser to bring information resources to the writer.

O ce 2003/2007 for creating, opening, editing or saving the text les,
workbooks and presentations in Microsoft O ce Word, Excel and Power
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Point.
A programme to view, create, edit or mange les in portable document
format (PDF) such as Adobe Acrobat Professional.
Drug Discovery
Spellchecker, software to check the spelling errors in the printable document
and Clinical
or web pages. 414
Research
SK Gupta An online Dictionary and Thesaurus to search for any de nition or meaning
instantaneously.
Antivirus software for complete protection from the computer virus, worms
or any other malware.

 CHAPTER 1: New Drug Development  

 CHAPTER 2: Drug Discovery And Developmen
Of Biologics
PROFESSIONAL GAINS
 CHAPTER 3: Clinical Development Of New
Drugs
 CHAPTER 4: Phase 0 Trials In Cancer Drug Good medical writing can stimulate the company's economic growth. Well
Development written documents and communications can:
 CHAPTER 5: Bioethics In Clinical Research
 CHAPTER 6: Medical Devices—Regulations
1. Save unnecessary repetitions of clinical trials.
And Research
2. Reduce the time taken for the product marketing approvals.
 CHAPTER 7: Clinical Development Of Vaccines
3. Increase the marketing duration of the product under patent protection.
 CHAPTER 8: Clinical Development Of
Anticancer Molecules 4. Lead to the successful marketing of the product.
 CHAPTER 9: Role Of Pharmacovigilance In
Clinical Research 5. Reduce the period of the product marketing approval process.
 CHAPTER 10: Data Management In  

 ORGANIZATIONS FOR MEDICAL AND SCIENCE WRITERS

Several medical writing organizations are working in a direction to provide an

opportunity to writers to meet and share their experience and expertise. These
organizations help in promoting the professional development and excellence in
documentation. The writers are also bene ted by nding career opportunities.
These organizations offer fundamental medical writing training to amateurs.

Organizations For Medical And Science Writers And Their

Websites

1. American Medical Writers Association (AMWA)

(Http://Www.Amwa.Org)

2. Australasian Medical Writers Association (AuMWA)

(Http://Www.Medicalwriters.Org)

3. European Medical Writers Association (EMWA)

(Http://Www.Emwa.Org)

4. Indian Medical Writers Association (IMWA) (Http://Imwa.Webs.Com)

5. Drug Information Association (DIA) (Www.Diahome.Org)

6. Association for Communication Excellence in Agriculture, Natural

Resources and Life and Human Sciences (ACE)
(Http://Www.Aceweb.Org)

7. Association of British Science Writers (ABSW)

(Http://Www.Absw.Org.Uk)

8. Guild of Health Writers (UK) (Http://Www.Healthwriters.Com)

9. Health and Science Communications Association (H&SCA)

(Http://Www.Hesca.Org)

10. National Education Technology Writers Association (NETWA)

(Http://Www.Netwa.Org)

11. New England Science Writers (NESW) (Http://Neswonline.Com/)

12. Canadian Science Writers’ Association (CSWA)

13. (Http://Www.Sciencewriters.Ca)

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14. International Science Writers Association (ISWA)

(Http://Internationalsciencewriters.Org)

15. World Association of Medical Editors (WAME), for editors of peer-

Drug Discovery reviewed medical journals (Http://Www.Wame.Org)
and Clinical
16. World Federation of Science Journalists (WFSJ) (Http://Wfsj.Org)
Research
SK Gupta
415
Medical writing as a career has given many people a satisfaction of
ful lling their dreams. Though it is tough and sometimes demanding, still it
gives a job satisfaction, a wide circle of friends and unexpected job opportunity
 CHAPTER 1: New Drug Development
at the later stage of life with good remuneration.
 CHAPTER 2: Drug Discovery And Developmen
Of Biologics
 CHAPTER 3: Clinical Development Of New
Drugs
 CHAPTER 4: Phase 0 Trials In Cancer Drug
Development
 CHAPTER 5: Bioethics In Clinical Research
 CHAPTER 6: Medical Devices—Regulations
And Research
 CHAPTER 7: Clinical Development Of Vaccines
 CHAPTER 8: Clinical Development Of
Anticancer Molecules
 CHAPTER 9: Role Of Pharmacovigilance In
Clinical Research
 CHAPTER 10: Data Management In

416

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Drug Discovery
and Clinical
Research
SK Gupta

 CHAPTER 1: New Drug Development

 CHAPTER 2: Drug Discovery And Developmen
Of Biologics
 CHAPTER 3: Clinical Development Of New
Drugs
 CHAPTER 4: Phase 0 Trials In Cancer Drug
Development
 CHAPTER 5: Bioethics In Clinical Research
 CHAPTER 6: Medical Devices—Regulations
And Research
 CHAPTER 7: Clinical Development Of Vaccines
 CHAPTER 8: Clinical Development Of
Anticancer Molecules
 CHAPTER 9: Role Of Pharmacovigilance In
Clinical Research
 CHAPTER 10: Data Management In

1The last three symbols are unlikely to be needed in marking proofs of photocomposed
matter. Source: Http://Www.Merriam-Webster.Com/Mw/Table/Proofrea.Htm
417

BIBLIOGRAPHY
1. AMA Manual of Style: A Guide for Authors and Editors (Hardcover) JAMA and Archives

Journals (Author) 2007 Oxford University Press,  New York. 

2. Dietel M. Requirements for medical writing. Obesity Surgery 2004;14:3–7.

3. Http://Ezinearticles.Com

4. Http://Www.Espressographics.Com/Files/Proofread.Pdf

5. Http://Www.Medicalwritingtraining.Com

6. Http://Www.Merriam-Webster.Com

7. Http://Www.Pharmweb.Net/Pwmirror/Pwk/Pharmwebk.Html

8. Http://Www.Spd.Dcu.Ie/MAIN/Administration/Careers/Documents/EMWACareersLea etmedi

calwriting.Pdf

9. Http://Www.Writersandeditors.Com/Science_and_medical_writing_30796.Htm#Bookmark1

10. Http://Www.Writerswrite.Com

11. Medical Writing 101: A Primer for Health Professionals, Arnold Melnick, AuthorHouse™,

Bloomington, Indiana, USA, 2006.

12. Ng K H, Peh W C G. E ective Medical Writing. Pointers to getting your article published.

Singapore  Med J 2009;50(12):1134.

13. PubMed (Http://Www.Ncbi.Nlm.Nih.Gov/Entrez)

14. The Complete Guide to Medical Writing by Mark C. Stuart, Pharmaceutical Press,  London 

2007.

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15. Tool kit for New Medical Writers by the Delaware Valley Chapter of the American Medical

Writers Association Http://Www.Amwa-Dvc.Org/

Drug Discovery
and Clinical
Research
SK Gupta

 CHAPTER 1: New Drug Development

 CHAPTER 2: Drug Discovery And Developmen
Of Biologics
 CHAPTER 3: Clinical Development Of New
Drugs
 CHAPTER 4: Phase 0 Trials In Cancer Drug
Development
 CHAPTER 5: Bioethics In Clinical Research
 CHAPTER 6: Medical Devices—Regulations
And Research
 CHAPTER 7: Clinical Development Of Vaccines
 CHAPTER 8: Clinical Development Of
Anticancer Molecules
 CHAPTER 9: Role Of Pharmacovigilance In
Clinical Research
 CHAPTER 10: Data Management In

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