Slide
1. Definition
o A scientific literature review is a synthesized summary of published research.
o It involves a critical analysis of existing studies rather than just summarizing
them.
2. Purpose
o The goal is to search, evaluate, and summarize the available evidence.
o It uses both informal and structured methods to collect and interpret relevant
studies.
3. Combination of Art and Science
o Writing a literature review is not just about technical research but also about
effective communication and interpretation.
o The art lies in how well the writer connects various studies and presents findings.
o The science involves following structured research methods to ensure credibility.
4. Role in Research
o Helps researchers gather and filter publications that fit specific criteria.
o It ensures the inclusion of only relevant studies to answer a specific research
question.
5. Following a Defined Protocol
o A scientific literature review must have a clear protocol or plan.
o The inclusion and exclusion criteria for selecting studies must be defined
beforehand to avoid bias.
Slide
Basic Principles of Literature Search
This slide outlines the fundamental steps in conducting a systematic and effective literature
search. Here’s a breakdown of each principle:
1. Use “PICO” Criteria to Formulate an Answerable Question
o The PICO model is a structured framework for developing research questions,
especially in clinical and medical research.
o PICO stands for:
P (Patient/Population): Who is the study about? (e.g., pregnant women
with diabetes)
I (Intervention): What is being tested or studied? (e.g., real-time
continuous glucose monitoring)
C (Comparison): What is the alternative to the intervention? (e.g., usual
care)
O (Outcome): What result is being measured? (e.g., glycemic control)
o Using PICO helps create a focused and answerable research question.
2. Decide on the Type of Literature Needed
o Identify the type of research relevant to your question:
Systematic reviews
Randomized controlled trials (RCTs)
Cohort studies
Case studies
o Selecting the right type ensures high-quality, evidence-based findings.
3. Choose Practical Databases for Search
o Different databases store different types of research.
o Common databases for medical and health research include:
PubMed (for biomedical literature)
Cochrane Library (for systematic reviews)
Embase (for pharmacology and clinical research)
Google Scholar (for a broader range of sources)
o Selecting the right database improves search efficiency.
4. Define Key Terms and Alternate Terms
o Use keywords that describe the research question.
o Identify synonyms and alternative terms to expand search results.
o Example:
Key Term: “continuous glucose monitoring”
Alternate Terms: “real-time CGM,” “diabetes monitoring device”
o This ensures a comprehensive search without missing relevant studies.
5. Refine Your Search as Necessary
o After the initial search, review the results.
o Apply filters (e.g., date range, study type, population) to narrow down the
findings.
o Modify keywords or Boolean operators (AND, OR, NOT) to improve search
relevance.
What is a Research Question?
A research question is a clear, focused, and specific question that guides a study or
investigation. It defines what the researcher wants to explore, analyze, or solve. A well-
structured research question helps in identifying relevant studies, collecting data, and drawing
meaningful conclusions.
Characteristics of a Good Research Question:
A good research question should be:
1. Specific – Clearly defines what is being studied.
2. Focused – Narrow enough to be answered thoroughly.
3. Measurable – Can be answered with data or evidence.
4. Relevant – Important to the field of study.
5. Feasible – Can be researched within the available time and resources.
Example Using Your Topic:
Your topic is:
"The efficacy of real-time continuous glucose monitoring vs usual care on glycemic control in
patients with diabetes in pregnancy."
A research question based on this topic could be:
➡️"Does real-time continuous glucose monitoring improve glycemic control compared to
usual care in pregnant women with diabetes?"
Types of Research Questions
1. Descriptive – Seeks to describe characteristics or trends.
o "What are the common challenges faced by pregnant women using continuous
glucose monitoring?"
2. Comparative – Compares two or more groups.
o "How does real-time continuous glucose monitoring compare to usual care in
managing blood sugar levels during pregnancy?"
3. Causal (Cause-and-effect) – Examines the effect of one factor on another.
o "Does continuous glucose monitoring reduce the risk of complications in
pregnant women with diabetes?"
Slide
What is PICO Strategy?
PICO is a framework used in clinical research and evidence-based medicine to define a research
question and conduct literature searches effectively.
PICO Component Your Example
P (Population) Pregnant women with diabetes
I (Intervention) Real-time continuous glucose monitoring
C (Comparison) Usual care (standard blood glucose monitoring)
O (Outcome) Improved glycemic control
Analogy:
Think of PICO as a recipe for making a dish. If you want to bake a cake, you need specific
ingredients (P - flour, eggs, sugar, etc.), a special technique (I - baking method), an alternative
method for comparison (C - steaming vs baking), and the final result (O - a fluffy cake or not).
By structuring a research question with PICO, you ensure clarity and precision in literature
searches.
3. How to Use Boolean Operators in Literature Searches?
Boolean operators (AND, OR, NOT) are used in database searches to combine or exclude
keywords to refine search results.
Boolean
Function Example with Your Topic
Operator
Narrows search by including both "Continuous glucose monitoring AND pregnancy
AND
terms diabetes"
Broadens search by including either
OR "Glycemic control OR blood sugar levels"
term
NOT Excludes a term from the search "Diabetes in pregnancy NOT type 1 diabetes"
Slide
Real Example: Semaglutide (Ozempic, Wegovy) – A Case Study for
Investigator’s Brochure Review
Let's say we are preparing an Investigator’s Brochure (IB) for Semaglutide, a GLP-1 receptor
agonist initially developed for Type 2 Diabetes (T2D). We need to investigate whether the drug
has been:
✅ Approved in other countries
✅ Studied for different therapeutic indications
Step-by-Step Peer Review Process Using a Real Example
Step 1: Define the Research Question (PICO Strategy)
P (Population): Patients with Type 2 Diabetes, Obesity, or other metabolic disorders
I (Intervention): Semaglutide
C (Comparison): Standard treatment, placebo, or alternative GLP-1 drugs
O (Outcome): Glycemic control, weight loss, cardiovascular benefits
Research Question Example:
"Has Semaglutide been studied or approved in other countries for conditions beyond Type 2
Diabetes?"
Step 2: Conducting the Search Using Boolean Operators
Using Boolean operators, we search across different sources:
Example search query in PubMed/Google Scholar:
"Semaglutide AND (obesity OR weight loss OR cardiovascular OR kidney disease) AND
(approval OR clinical trial OR regulatory)"
Step 3: Searching in Regulatory & Clinical Trial Databases
1️⃣ Checking Global Regulatory Approvals
Regulatory Agency Approval Found? Indication Brand Name
FDA (USA) ✅ Approved Type 2 Diabetes Ozempic
FDA (USA) ✅ Approved Obesity/Weight Loss Wegovy
EMA (Europe) ✅ Approved Type 2 Diabetes Ozempic
EMA (Europe) ✅ Approved Obesity Wegovy
TGA (Australia) ✅ Approved Type 2 Diabetes Ozempic
Health Canada ✅ Approved Type 2 Diabetes & Obesity Ozempic, Wegovy
China (NMPA) ✅ Approved Type 2 Diabetes Rybelsus (Oral Semaglutide)
🔹 Key Finding: Semaglutide is globally approved for Type 2 Diabetes and Obesity under
different brand names.
2️⃣ Searching in Clinical Trial Databases
Using ClinicalTrials.gov and WHO ICTRP, we check for ongoing studies on new indications:
Trial ID Condition Studied Status Location
NCT03574597 Obesity in non-diabetics Completed USA, EU, Canada
NCT04881760 Heart Failure & Obesity Ongoing USA
NCT03819153 Chronic Kidney Disease (CKD) & Diabetes Ongoing Global
NCT04777409 Polycystic Ovary Syndrome (PCOS) Ongoing UK, Australia
🔹 Key Finding: Semaglutide is being tested for Chronic Kidney Disease, Heart Failure, and
PCOS.
Step 4: Searching in Peer-Reviewed Literature
Using PubMed and Google Scholar, we check for studies supporting these findings:
📄 Example Articles Found:
Title: Efficacy of Semaglutide in Obesity and Type 2 Diabetes
o Source: New England Journal of Medicine (2021)
o Key Finding: Showed significant weight loss in obese patients without diabetes.
Title: GLP-1 Agonists and Cardiovascular Outcomes
o Source: The Lancet (2023)
o Key Finding: Semaglutide reduced cardiovascular risk in diabetic patients.
🔹 Key Finding: Semaglutide has strong evidence supporting its cardiovascular and weight-
loss benefits.
Step 5: Cross-Checking with Manufacturer Websites
🔹 Novo Nordisk’s Pipeline (Official Website):
Confirms new trials on Alzheimer’s disease, Fatty Liver Disease (NASH), and Kidney Disease.
Future expansion of semaglutide use beyond diabetes.
Final Summary for the Investigator’s Brochure (IB)
📌 Drug Name: Semaglutide
📌 Current Approved Uses:
✅ Type 2 Diabetes – Approved globally (Ozempic, Rybelsus)
✅ Obesity Management – Approved in USA, EU, Canada, Australia (Wegovy)
📌 New & Ongoing Research (Potential Future Indications):
🔬 Chronic Kidney Disease (CKD) – Ongoing clinical trials
🔬 Cardiovascular Disease Prevention – Positive trial results
🔬 Polycystic Ovary Syndrome (PCOS) – Early-stage trials
📌 Regulatory & Research Findings:
📌 FDA & EMA approvals for multiple conditions
📌 Strong peer-reviewed evidence supporting additional benefits
📌 Company pipeline suggests further expansion
Conclusion
This real-world example of Semaglutide shows how to systematically conduct a peer review
when preparing an Investigator’s Brochure. The same approach can be applied to any drug by
following these structured steps.
Let me know if you need a similar review for another drug! 😊
