MO D U L E 4 :Medical Writing

C LR I
Vandana Parashar

Disha Angra
Let’s get into basics

THINK OF A RESEARCH QUESTION????

How to frame a research question?

Observational Studies Interventional studies

P (Population) P (Population)
E (Exposure) I (Intervention)
C (Control) C (Control)
O (Outcome) O (Outcome)
Examples

Among newborns, what is the effect of 10 dB exposure to noise during gestation versus 10 dB incremental increase
on Postnatal hearing impairment?

Cetuximab + supportive care compared with supportive care alone in metastatic epidermal growth factor receptor
positive colorectal cancer in improving overall survival
 Introduction to Medical Writing

Medical writing involves writing scientific documents of different types

which include regulatory and research-related documents, disease or A medical writer usually closely works with scientists, doctors and other
drug-related educational and promotional literature, publication articles subject matter experts to create effective documentation that vividly
like journal manuscripts and abstracts, content for healthcare websites, defines research results and product's usage.
health-related magazines or news articles.
 Skillset to be a Medical Writer

Domain knowledge. Substantial knowledge of varied therapeutic areas,

regulatory/scientific guidelines, and key statistical concepts.
 Regulatory knowledge: awareness of drug development regulations is important
Understanding statistical analysis: interpreting data from clinical studies, which use a
variety of statistical methods.
 Ability to understand the purpose and requirements of the project
 Interpretation and presentation of research data
 Language & grammar
 Literature /reference searching
 Secondary Skillset to be a Medical Writer

 Ability to think, logical organization of thoughts and ideas

 Attention to details- specifically over critical data
 Organize, prioritize, and multi-task
 People management
 Creative writing ability
 Data Integrity
 Keeping current
 Know your audience
 Time management
 Scope for Medical Writing
News
An organic domain
News
within the
Biopharmaceutical
industry.
India's domestic
pharmaceutical
market is estimated
at US $41 billion in
2021 and is likely
to grow to US$65
billion by 2024
India is the third-
News
largest producer of
pharmaceutical
products in the world
Total Annual Turnover
of Pharmaceuticals
was Rs. 2,89,998 crore
for the year 2019-
2020.
India’s pharmaceutical
sector forms a major
component of the
country’s foreign trade
India has the second-
highest number of US
FDA-approved plants
outside the US. India is a
global leader in the supply
of DPT, BCG, and
Measles vaccines. India
accounts for 60 percent of
global vaccine production,
contributing 40 to 70
percent of the WHO
demand for Diphtheria,
Tetanus, and Pertussis
(DPT) and Bacillus
Calmette–Guérin (BCG)
vaccines, and 90 percent
of the WHO demand the
measles vaccine.
 Categories of Medical Writing

1. Regulatory medical writing

2. Educational medical writing.

3. Scientific medical writing.

 Regulatory medical writing

 Regulatory writing is the

development of preclinical and
clinical research procedures into
documents and submission
Informed consent form Study protocol Clinical study report
packets that review and record
essential study conduct,
practices, and results.
 Writers within this discipline
ensure clarity of study statistical
analyses, protocol guidelines,
toxicology reporting, and
Risk evaluation plan Mitigation plans
governmental agency-specific
documentation and submission
packets needed for approval and
ongoing research practices.
Informed consent form

Informed consent forms

(ICFs) are the main
documents used by study
site personnel for
familiarizing potential
volunteer subjects with
the details of a specific
clinical trial.
Study protocol and clinical study reports
Study Protocol
• Regulatory writers help to develop the
protocol’s explanations of guidelines
and study procedures with oversight
and input from the study investigators.
• Protocols usually follow a generalized
structure that includes sections on
therapeutic background, study design,
inclusion and exclusion criteria for
participation, treatment formulation
and administration criteria, toxicities
and reporting criteria, statistical
considerations for efficacy
determination, and appendices.
Clinical study report
• Clinical study reports (CSRs) act as
comprehensive summaries of the efficacy,
accumulated toxicity, and other statistical
outcomes of clinical data, and are one of the
International Council for Harmonization (ICH)
E6 Essential Documents following a clinical
trial.
• Regulatory writers are tasked with composing
these reports about the safety and efficacy
raw data outputs, which can be quite
extensive with a multitude of statistical
variation.
 Educational/training based medical writing

Patient information
 Composition of therapeutic and
product information to educate
clinicians and other medical
professionals
 Composition of medical
directions and warnings for drug
use to patients and clinicians
Package inserts/instruction
pamphlets, warning
Brochures related to a
boxes/lists, lists of
leaflets pharmaceutical product active/non-active
ingredients
Internal educational/
training content (e.g.,
Newsletters
advisory board slide
decks)
 Scientific medical writing

 Composition of study
Conference materials such as
design/methods, data Journal manuscripts posters, abstracts and oral
analyses, and clinical trial presentations
results of an intervention(s)
or studied medical topic for
peer review.

Internal documents (i.e.,

publication planning)
 What Do Medical Writers Write?
 Abstracts for medical journals and medical
conferences
 Advertisements for pharmaceuticals, devices,
and other products
 Advisory board summaries
 Medical education materials
 Patient educations aids
 Grant proposals
 Health care policy documents
 Health education materials
 Magazine and newspaper articles
 Medical and health care books
 Medical and scientific journal articles, white papers
Protocol, CSR, Patient Narratives, Package Inserts, IB,
NDA, CTD
 Clinical research manuscripts usually include
Introduction, Methods, Results, and Discussion (IMRAD
 Marketing materials
 Poster presentations for medical conferences
 Regulatory documents, including FDA submissions
 Sales training
What Do Medical Writers in CRO write?

•The Common Technical Document (CTD)

New Drug Applications (NDAs)

•Marketing Authorisation Applications (MAAs)

•Supplemental NDAs and MAA variations

•Core dossier preparation

•Integrated safety and efficacy summaries

(ISS/ISE)
What Do Medical Writers in CRO write?

•Serious adverse event (SAE) narratives

Clinical Evaluation Reports (CERs)

•Non-clinical reports

•Regulatory responses

•Integrated safety and efficacy summaries (ISS/ISE)

•Briefing documents
Planning & Layout for Medical Writing
 Steps in writing scientific documents
Understanding project specific/sponsor-
specific requirements.
 Primary & Secondary research question
Literature search(Data Mining) & review
of information
Creating the first draft document by
compiling and authoring (client style
guide, templates, SOP)
 Review cycle- content, format, source is
reviewed by peer, QC
Formatting & Editing- making the document
more presentable and acceptable, proofread, copy
edited and ready for approval
Approval- The document needs to approve by
the sponsor and designated approver inter &
external. There could be another cycle of review &
editing.
Signature- This is the final step of the document
cycle. All the designated authorities sign off the
document.
Publishing(Electronic)- making the material
available for the conduct of the study in digital
format
• Biotechnology companies
• Clinical or contract research
organizations (CROs)
• Pharmaceutical companies
• Government agencies
Core Areas for
• Health care organizations or providers
profession
• Medical book publishers/Authors
• Medical device companies
• Medical education companies/Textbook
• Medical schools or universities/Professors
• News outlets for health/medical news
• Medical journals agencies
• Trade journals for health care professionals
 Module 2- Scientific Writing

Scientific writing is a method of creating a scientific & technical document that emphasizes
more measurement and observation and not opinion.
Scientific writing is the most important means of communicating research findings.
A science paper will record results, and design tables and graphs to present data in a logical
and organized format.
A scientific paper usually includes the following parts:
a Title (statement of the question or problem), an Abstract (short summary of the paper),
an Introduction (background and significance of the problem), a Materials and Methods
section (report of exactly what you did), a Results section (presentation of data), a
Discussion section (interpretation and discussion of results), and References (books and
periodicals used). A Conclusion (concise restatement of conclusions) may also be included.
 Module 2- Scientific Writing

Under Scientific Writing, we can understand how below mentioned topics are generated.
▪ Scientific News: science, medicine, and technology broadly, including new findings and
techniques, surprising statistics, and the latest science trends.
▪ Scientific Reviews: A scientific literature review is a critical account of what has been
published on a topic by accredited researchers.
▪ Scientific Research Paper for Journals: Scientific papers (also known as "journal articles")
are usually published in a periodical called a journal, They are peer-reviewed, They
are citable, standardized style of writing.
▪ Case Reports: An article that describes and interprets a unique individual case that cannot
be explained by known diseases or syndromes, often written in the form of a detailed
story.
 Scientific News

1 News Title
This is the primary title for the News
2 News Summary
This is a textual summary of the news, this will be displayed in all the teaser modes of
news.
3 News Description
This is a description of the news, it will describe the event and it will be a mixture of
text/media/videos.
4 Hero Image
This is a hero image for the news, This will be displayed on the news teaser thumbnail and
also as a news banner
5 Tags
These are the tags for the news, they will be used to group list of related news.
M O D U L E 4: M E D I C A L W R I T I N G
(MINORMODULE)

MODULE 4: PRE-CLINICAL/NON-CLINICAL WRITING

What is Clinical and Non-Clinical Writing
Clinical Study
Patient information reports
(PIRs)
Clinical trial study data
reports
Pharmacovigilance
documents like annual safety
reports
Periodic adverse drug
experience reports (PADER)
Common Technical
Document (CTD)
Patient safety narratives
Clinical trial protocols
NON-Clinical Study
Pre-IND Supporting Documents
Pharmacological Written Summary
Pharmacological Tabular Summary
Toxicological Written Summary
Toxicological Tabular Summary
Non-clinical part of IND package
(electronic Common Technical
Document [eCTD]
Preparation and review of Nonclinical
Overview
Preparation and review of Nonclinical
Summary/Summaries
Preparation and review of Nonclinical
Study Report
Preparation and review of Nonclinical
Protocol High-Quality
International Conference on Harmonisation (ICH)

International Conference on Harmonization (ICH) is the international

body comprising regulatory agencies and pharmaceutical industry
experts in Europe, US, and Japan that defines standards within
scientific and technical aspects of drug registration, including setting
standards for the format and content of regulatory documentation.
ICH harmonization activities fall into 4 categories: Formal ICH
Procedure, Q&A Procedure, Revision Procedure, and Maintenance
Procedure, depending on the activity to be undertaken.
ICH Guidelines are implemented in accordance with the applicable
national/local/regional rules, with the stage of implementation of all
ICH Guidelines also being dependent on when a Member or Observer
has joined ICH.
Data harms

▪ Privacy breaches (unjustified or unauthorized intrusions into

a patient’s personal sphere);
▪ Discrimination and stigma (data may be used to
characterize individuals or groups in ways that confer
disadvantages);
▪ Disenfranchisement (a lack of transparency and
engagement regarding secondary data use);
▪ Disempowerment (a loss of control and agency over
secondary uses of data); and/or
▪ Exploitation (patients or data producers do not benefit
sufficiently from secondary uses of clinical data).
 Safety Narratives

 Also called “Patient

narratives”
 Important content of
CSR document
Patient safety narratives
should be prepared for all
Medical writers are phases of clinical studies
responsible to write
PN
 Safety Narratives

For Clinical trials SNR is

The objective of SNW is to important to include
summarize all relevant
clinical information. Protocol or study
number/ID/Name
 Study title
 Phase of the study
Screening
number/randomization
number
 Patient ID/No/Subject ID
 Content of Safety Narrative
1. Report Type
2. Patient demographic data
3. PT Medical history
4. Concomitant Medication information
5. IP information
6. Clinical course of events
corresponding to drug administration
7. Intensity, Severity, outcome of event
8. Relevant lab findings
9. Concomitant therapy
10. Action taken w.r.t to drug
11. Relation of a drug to IP
12. Outcome of the event(death)
13.Medical evaluation & reporter’s
comment
Structure & Format

 Concise & Precise

 Spell & Grammar
 Agreed Chronology
 No usage of short forms
 Exact same words should be the same as in the Source
 Do not use additional supportive words
 Use of third person past tense
 Values should be always in SI units
 Paragraphing is key
 Medico Marketing

Medico-Marketing is a process of information exchange that happens between a drug

manufacturer and the consulting doctor, Nurse, Pharmacist, or patient.

The objective of this exchange is to explain the company’s products and how they will
assist the consumers in the prognosis or treatment of the health-related problem.
 List of documents Medico Marketing use

▪ Product monographs ▪ e-learning modules for physicians and

▪ Leave-behind literature patients

▪ Brochures ▪ Whitepapers

▪ Visual aids ▪ Web content

▪ Newsletters ▪ Patient Stories

▪ Health blogs ▪ Emailers

▪ Salesforce training manuals

M O D U L E 5: M E D I C A L W R I T I N G
for Clinical Trial
 Development Safety Update Report DSUR

DSURs are new, internationally-harmonized, safety documents covering the

safety summary of medicinal products during their development or clinical trial
phase.
Sponsors are required to submit a DSUR within one year of the date of first
authorization of a clinical trial in any country worldwide.
DSUR is drafted based on the available data from
below:

1. Interventional clinical Trials

2. Non-interventional CT, Compassionate, or observational studies.

3. Significant safety findings from non-clinical studies

4. Significant and relevant articles, literature.

Aggregate Reporting and Regulatory
Requirements

The periodic reports play a

The aggregate report plays an
important role in the safety
assessment of drugs; it is also
known as periodic reporting
and cumulative safety
information.
significant part in the drug
risk-benefit assessment and
involve collective case
analysis in the database,
tracking of regulatory action,
literature search etc.
The following types of reports are submitted for
post-marketing authorization

 Periodic Adverse Drug Experience Report (PADER)

 Periodic Benefit-Risk Evaluation Report (PBRER)/
 Periodic Safety Update Report (PSUR)
 Safety Assessment Reports
 Development Safety Update Reports (DSURs)
 Ad-hoc Reports
Risk
management
plans (RMP)
in the post-
authorization
phase
Risk management plans (RMP) in the
post-authorization phase

The RMP is a document which is shown the consistent risk

management of drugs from the development phase to the post-
marketing phase, is a document that describes the current
knowledge about the safety and efficacy of a medicinal product.
Clinical Evaluation
Report (CER)
CER

 A Clinical Evaluation Report (CER) documents the

conclusions of a clinical evaluation of your medical device.
 A CER consists of analyzed clinical data that was collected
either from a clinical investigation of your device, or the
results of other studies on substantially equivalent devices.
 The CER demonstrates that your device achieves its intended
purpose without exposing users and patients to further risk
 Clinical evaluation takes place in three steps. One-
manufacturers identify clinical data from existing literature,
clinical experience, clinical trials, or any combination of the
three.
 Elements in your CER
The clinical evaluation plan (CEP)
describes device sizes, the intended
purpose, target patient populations,
medical indications and the clinical
benefit to patients.
The next step is to identify the
available data on the device and
determine a literature review strategy.
• General information: device and
manufacturer name
• Concise physical and technical device
description and intended application
• Outline of intended therapeutic or
diagnostic claims
• Clinical evaluation and data types
• Summary of clinical data and review
• Describe analyses used to assess
performance, safety, and
relevance/accuracy of product literature
• Conclusions about safety, performance,
and conformity
Periodic safety update reports (PSURs)

The main objective of a PSUR is to present a comprehensive, concise,

and critical analysis of the risk-benefit balance of the medicinal
product.
Keeping into account new or emerging information in the context of
cumulative information on risks and benefits.
 The PSUR is therefore a tool for post-authorization evaluation at
defined time points in the lifecycle of a product.
Benefit-risk evaluation should be carried out throughout the lifecycle
of the medicinal product to promote and protect public health and to
enhance patient safety through effective risk minimization.
 Preparation of PSURs includes the following:
1. Non-clinical studies;
2. Spontaneous reports (e.g. on the
marketing authorization holder’s
safety database);
3. Active surveillance systems (e.g.
sentinel sites);
4. Investigations of product quality;
5. Product usage data and drug
utilization information;
6. Clinical trials, including research in
unauthorized indications or
populations;
7. Observational studies, including
registries;
8. Patient support programs;
9. Systematic reviews and meta-analysis;
10. Marketing authorisation holders sponsored
websites
11. Published scientific literature or reports from
abstracts, including information
presented at scientific meetings;
12. Unpublished manuscripts;
13. Licensing partners, other sponsors or
academic institutions and research
networks;
14. Competent authorities (worldwide)
ICH-E2C(R2) guideline (see Annex IV ICH-E2C(R2)
 Publish Tools

CONSORT: Consolidated Standards of Reporting Trials

The main product of CONSORT is the CONSORT Statement,
which is an evidence-based, minimum set of recommendations
for reporting randomized trials.
The CONSORT Statement comprises a 25-item checklist and a
flow diagram.
CHEERS: Consolidated Health Economic Evaluation Reporting
Standards
The Consolidated Health Economic Evaluation Reporting Standards
(CHEERS) statement is an attempt to consolidate and update previous
health economic evaluation guidelines efforts into one current, useful
reporting guidance.
SQUIRE: Standards for Quality Improvement Reporting Excellence
SQUIRE stands for Standards for Quality Improvement Reporting
Excellence. The SQUIRE guidelines provide a framework for reporting
new knowledge about how to improve healthcare.
STARD Initiative
Standards for Reporting of Diagnostic Accuracy (STARD)
The EQUATOR Network is an international initiative that seeks to enhance the reliability of medical
research literature by promoting transparent and accurate reporting of research studies.

The PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses)
The aim of the PRISMA Statement is to help authors report a wide array of systematic reviews to assess the
benefits and harms of a health care intervention.
It has a 27-item checklist used to improve transparency in systematic reviews.

STROBE -stands for Strengthening the Reporting of Observational Studies in Epidemiology

an international, collaborative initiative of epidemiologists, methodologists, statisticians, researchers and
editors involved in the conduct and dissemination of observational studies