Research methodology

Prepared by: -
Dr. Rajendra Kotadiya
Associate Professor and HOD
Quality assurance and Pharmaceutical
Analysis
PIPR, PU
 Course learning outcomes – What the student learns and can do?

CLO 1 Learn general research methodology helps to select the appropriate study design and develop
appropriate research hypothesis for a research project
CLO 2 Understand the basic concepts of biostatistics and Learn different parametric and non-
parametric tests
CLO 3 Understand the functions of ethics committees in medical research
CLO 4 Learn CPCSEA guidelines for laboratory animal facility
CLO 5 Study the genesis of bioethics with special reference to Helsinki declaration
Let us check our level
• [Link]
 Content for Unit 1

• Research
• Objective
• Requirements
• Practical difficulties
• Review of literature
• Study design
• Types of studies
• Strategies to eliminate errors/bias
• Controls
• Randomization
• Crossover design
• Placebo
• Blinding techniques.
What you know about the following:

• Information vs knowledge (PA)

• Information – Raw data/details collected from sources
• Knowledge – processed, organized and meaningful understanding
• Innovation vs invention vs research (PC)
• Innovation – solving real world problem
• Invention - Creation of a new product, process, or idea for the first time.
• Research - A systematic process of inquiry to generate knowledge.
• Research vs Research methodology vs Research problem (RA)
• Research – What? – Actual investigation
• Research methodology – How? – The approach
• Research problem – Why? – specific issue/gap
• Statistics vs biostatistics (QA)
• Statistics - Science of collecting, analyzing, interpreting numerical data.
• Biostatistics - Application of statistics in biological, medical, or health research.
 Aspect Research Research Methodology
A systematic investigation to gain The overall strategy or process used to conduct
Definition
knowledge or solve a problem. that research.
The end goal — discovering facts,
Focus The path or tools used to reach that goal.
relationships, or solutions.
“What is being studied?”
What it answers “How is the research being conducted?”
“Why is it important?”
Nature Descriptive or result oriented. Procedural or technique oriented.

Testing of a new formulation of Choosing a randomized controlled trial, deciding

Example in Pharmacy paracetamol reduces fever faster than the sample size, and applying statistical tests to
the standard tablet. analyze the fever reduction.

New findings, conclusions, theories, Valid, systematic, and reproducible methods of

Output
or solutions. generating results.

Without research, no knowledge is Without proper methodology, research may be

Importance
gained. invalid or biased.
1. Research
Definition: Research is a systematic and scientific approach to discovering new knowledge, validating
existing knowledge, and solving problems.

Research is broadly classified as:

1. Application based research
1. Basic or fundamentals – Formulation of theory, mathematical solution
2. Applied research – Involves experiments, covid vaccines
2. Objective based research
1. Descriptive – survey and fact findings enquiries, no control over variables, PCM brands
frequency
2. Correlational – establish existence of relationship, cigarette smoking and lung cancer
3. Explanatory – To clarify why and how there is a relationship b/n two or more phenomenon,
ex. Why stressful life living results in heart attacks.
4. Exploratory research – to explore area with little known. Ex Development of covid 19
medicines
3. Inquiry based research
1. Quantitative – measurement of quantity/amount. Ex. Determination of SARs Cov-2
antibodies quantity in a recovered patient.
2. Qualitative research – qualitative phenomenon, Ex. Detection of SARs Cov-2 antibodies in a
recovered patient (presence/absence)
2. Objectives of Research/Purpose: To define the aim and direction of the study.
 Exploration and Discovery: To uncover new phenomena, patterns, relationships, and principles. It often occurs in the
early stages when little is known. It aims to explore uncharted territory without necessarily having a hypothesis.
 Example:
 Discovery of a new bioactive compound in a medicinal plant during ethnopharmacological research.
 Screening unknown marine organisms for novel antibacterial activity.
 Explanation and Understanding: To develop theories, models, and frameworks that explain observed phenomena and
provide insights into underlying mechanisms. Researchers build models or theories to understand mechanisms behind
observed patterns. It answers the "cause-and-effect" question.
 Example:
 Investigating the mechanism of action of a new antiepileptic drug at the neuronal level.
 Understanding why certain patients are resistant to a specific class of antibiotics through genetic and
molecular analysis.
 Problem-Solving and Innovation: To identify and address practical problems, develop new technologies, and create
innovative solutions. Applied research often fits here-it translates findings into practical applications.
 Example:
 Developing a nanoparticle-based drug delivery system to improve the bioavailability of poorly soluble drugs.
 Formulating a new pediatric syrup that masks the bitterness of a commonly used antibiotic.
 Knowledge Generation and Dissemination: To contribute to the body of knowledge and share research findings with
the wider community. Research contributes to academic and professional fields and helps advance science through
publications, presentations, or databases.
 Example:
 Publishing the results of a clinical trial evaluating the safety and efficacy of a new antihypertensive drug.
 Presenting findings on medication adherence trends at a pharmacy conference.
 Decision Making and Policy Formulation: To inform evidence-based decision making and policy formulation in various
sectors. Research helps shape healthcare policies, public health interventions, and pharmaceutical regulations.
 Example:
 A pharmacoepidemiologic study showing increased adverse effects with a certain drug leads to regulatory action
by the DCGI.
• Example: "To assess the reduction in systolic blood pressure after 4 weeks of drug administration."
3. Basic Requirements for Research

Laboratory Infrastructure: For drug analysis or formulation research.

• Example: Analyzing dissolution rate of tablets in a pharmacy college lab.

Skilled Personnel: Need for trained supervisors and lab technicians.

• Example: Supervision by a pharmacology professor during animal studies.

Financial Resources: To procure materials, equipment, and software.

• Example: Funding for survey printing or lab reagents.

Time and Planning: Research must be scheduled to fit within academic deadlines.
• Example: Planning the study timeline across the semester.

Regulatory Approvals (DCGI, ICMR): Especially for clinical or drug trials.

• Example: Approval from DCGI for a study involving a new formulation in humans.
Further Requirements for Research
1. Clear and Well-Defined Research Questions
• Research questions must be specific, focused, and feasible.
Example:
A pharmacy student may ask: “What is the effect of patient counseling on medication adherence in
hypertensive patients?”
This is clear, measurable, and can guide the study’s methodology.
2. Appropriate Research Design
• The design must align with the objectives—quantitative for measuring effects, qualitative for exploring
experiences, or a mix of both.
Example:
A randomized controlled trial (quantitative) to test the impact of a new drug counseling module versus
standard care.
3. Rigorous Data Collection Methods
• Use validated tools, follow standard procedures, and minimize bias.
Example:
Using a validated medication adherence scale (e.g., Morisky Medication Adherence Scale) to collect data
from participants.
4. Systematic Data Analysis
• Apply correct statistical or qualitative methods; ensure transparency and reproducibility.
Example: A student uses SPSS to perform a paired t-test comparing pre- and post-counseling adherence
scores.
5. Ethical Considerations
• Protect participant rights, obtain informed consent, and get ethical clearance.
Example: Before starting a study on patient data, the student obtains approval from the Institutional
Ethics Committee and ensures data confidentiality.
6. Clear and Concise Reporting
• Present results clearly, include methodology, analysis, and interpretation.
Example: A student prepares a report detailing the background, study design, methods, statistical
analysis, findings, and conclusions in a structured format.
7. Validity and Generalizability
• Ensure results reflect reality (validity) and can apply to other groups (generalizability).
Example: If the study was conducted in a single community pharmacy, the student notes limitations in
generalizing to rural clinics or hospital settings.
8. Peer Review and Dissemination
• Subject findings to expert review and share them publicly.
Example: A student submits the project to the Indian Journal of Pharmacy Practice and presents it at a
national pharmacy conference.
Types of research

Type Description Example

Describes characteristics or facts

A survey shows that 60% of city
about a situation or population.
Descriptive residents prefer online shopping
Answers what, who, where, when,
over physical stores.
and how.

Explains why something is

An analysis showing that people
happening by exploring relationships
Analytical prefer online shopping due to better
or causes. Uses logic and statistical
prices and time-saving features.
analysis.
Types of research

Type Description Example

Uses numbers and statistics to
A study measuring the average test
understand phenomena. Often
Quantitative scores of students after online vs
includes surveys, experiments, or
offline learning.
structured data.
Explores meanings, experiences, or
Interviews with students about
opinions in depth. Often involves
Qualitative how they felt and what they
interviews or open-ended
experienced during online learning.
questions.
Types of research

Type Description Example

Focuses on theories and ideas. No A paper proposing a new theory of
Conceptual data collection—relies on existing consumer motivation based on
knowledge. existing psychological models.
Based on real-world data. Tests An experiment studying whether
Empirical theories or hypotheses through customers buy more when prices
observation or experiments. end in ".99".
Research Type Description Objectives Methods Examples
Descriptive Focuses on describing To gather Surveys, - Describing the demographics of a
Research and understanding the information about observations, population - Identifying the most
characteristics of a the what, who, interviews common symptoms of a disease -
phenomenon or when, where, and Understanding the prevalence of a
population. how of a particular behavior
phenomenon.
Analytical Aims to explain the To identify patterns, Statistical - Examining the relationship
Research reasons or causes behind correlations, and analysis, between smoking and lung cancer -
observed phenomena or causal relationships hypothesis testing, Determining the effectiveness of a
relationships. between variables. experiments new drug therapy - Understanding
the factors that contribute to
academic achievement
Research Type Description Objectives Methods Examples
Applied Seeks to solve practical To develop new Field studies, pilot - Developing a new vaccine for a
Research problems and improve technologies, studies, clinical disease - Implementing a new
conditions in the real interventions, or trials educational program - Designing a
world. solutions to address more efficient transportation system
specific problems.
Fundamental Driven by curiosity and To develop new Literature reviews, - Understanding the origins of the
Research the desire to expand our theories, models, theoretical universe - Exploring the nature of
knowledge and and principles that discussions, case consciousness - Deciphering the
understanding of the explain fundamental studies genetic code
natural world or human phenomena.
society.
Research Type Description Objectives Methods Examples
Quantitative Emphasizes the To provide Surveys, - Analyzing the relationship
Research collection and analysis generalizable experiments, between income and education -
of numerical data to findings that can be statistical analysis Comparing the effectiveness of two
quantify relationships, applied to a broader different teaching methods -
trends, and patterns. population. Measuring the impact of a new
policy
Qualitative Focuses on To provide in-depth Interviews, - Exploring the lived experiences of
Research understanding the insights into observations, people with disabilities -
experiences, meanings, individual or group document analysis Understanding cultural beliefs and
and perspectives of experiences and practices - Analyzing historical
individuals or groups. understandings. documents
Research Type Description Objectives Methods Examples
Conceptual Concerned with To advance our Literature reviews, - Developing a new theory of
Research developing and refining understanding of a theoretical organizational behavior - Refining a
theories, models, and phenomenon discussions, case model of language acquisition -
frameworks. through logical studies Proposing a new framework for
reasoning and understanding social inequality
analysis.
Empirical Involves collecting and To provide empirical Experiments, - Testing the effectiveness of a new
Research analyzing data to test evidence to support surveys, drug therapy - Examining the
hypotheses and develop or refute theoretical observations, relationship between stress and
theories. propositions. statistical analysis health - Evaluating the impact of a
social intervention
Type of Research Purpose Example

Basic Research Understand fundamental principles Mechanism of drug action studies

Applied Research Solve practical problems New drug formulation development

Descriptive Research Describe characteristics Prevalence survey of self-medication

Analytical Research Analyze existing data Risk factor analysis for adverse reactions

Quantitative Research Statistical analysis of numerical data Measuring blood pressure reduction

Qualitative Research Explore experiences/concepts Patient interviews on medication adherence

Test cause-and-effect in controlled Randomized controlled trial of a new

Experimental Research
settings vaccine

Observational Research Observe outcomes without intervention Cohort study of drug side effects

Case Study/Report Detailed analysis of single/small cases Reporting rare adverse drug reaction

Retrospective Research Analyze past data Hospital record review for complications

Long-term efficacy monitoring of new

Prospective Research Follow subjects into the future
treatment
4. Practical Difficulties

Common Issues:

Ethical concerns

Participant recruitment

Budget constraints

Regulatory delays

Data management issues

• Example: Delays in IEC approval for a clinical trial.
📚 Key Research-Related Terms in Pharmacy
1. Hypothesis
A prediction or educated guess that the research is designed to test.
 Example: “Drug A is more effective than Drug B in reducing pain.”
2. Study Design
The structure or blueprint of how the research is carried out.
 Example: Randomized Controlled Trial (RCT), Case-Control Study.
3. Variables
Elements that are measured or manipulated in a study.
 Independent variable: What the researcher changes (e.g., type of drug).
 Dependent variable: What is measured (e.g., blood pressure level).
4. Control Group
• A group in the study that receives no treatment or a standard treatment for comparison.
5. Placebo
A fake treatment (e.g., sugar pill) that has no therapeutic effect, used to compare against real drugs.
6. Blinding
Keeping study participants or researchers unaware of which treatment is being given to avoid bias.
 Single-blind: Only the participant is unaware.
 Double-blind: Both participant and researcher are unaware.
7. Randomization
Assigning participants to different groups purely by chance to eliminate bias.
8. Sample Size
The number of subjects included in a study. It affects how reliable the results are.
9. Bias
Any factor that can skew or affect the results of a study in a misleading way.
10. Statistical Significance
• A measure of whether the results are likely due to chance or represent a real effect. Often judged using the P-value.
5. Review of Literature
Purpose: To understand existing work and identify gaps.
Sources:
• Databases: PubMed, Scopus, WOS, ScienceDirect,
• Journals: IJPER, JPP
Process:
• Keyword search
• Inclusion/exclusion criteria
• Summarizing and referencing
6. Study Design
Definition:
• It refers to the overall strategy or plan for conducting research
• The plan for collecting, measuring, and analyzing data.
• Components:
• Research Question: Clear definition of the problem or hypothesis being tested.
• Variables: The factors that will be measured or controlled (e.g., age, gender, treatment type).
• Sampling: The process of selecting participants or units for the study.
• Data Collection Methods: Through surveys/experiments/interviews, etc.
• Analysis Plan: How the collected data will be analyzed to draw conclusions.
• Example: For a study on the impact of exercise on heart disease, the design might involve
selecting a group of patients, administering a fitness program, and measuring their heart
disease risk factors (like cholesterol levels) before and after the program.
• Type 1 - Observational Studies: These studies observe and analyze phenomena without intervention or
manipulation. Researchers only collect data and analyze it, but do not influence the study participants.
• Examples:
• Cohort Study: Involves observing a group of people over time to study how a certain factor affects
an outcome.
• Example: A cohort study might track people who smoke and people who don't smoke, over
several years, to compare the incidence of lung cancer in both groups.
• Case-Control Study: Involves comparing individuals with a specific condition (cases) to those
without the condition (controls) to identify risk factors.
• Example: Researchers might compare people who have developed lung cancer (cases) with
those who haven't (controls) to determine if smoking is a significant risk factor.
• Type 2 - Experimental Studies: These studies involve manipulation or intervention by the researcher to
observe its effects.
• Example: A clinical trial where one group receives a new drug (experimental group), while the other
group receives a placebo (control group). Researchers then compare the effects on health outcomes
between the two groups.
7. Other types of Studies

Descriptive: Describe characteristics, e.g., prevalence studies

Analytical: Explore relationships, e.g., case-control, cohort studies

Quasi-experimental: Non-randomized interventions

Pharmacovigilance: Detect adverse drug reactions

• Example: A cohort study to evaluate the long-term safety of statins.
Strategies to Eliminate Bias
8. Strategies to Eliminate Errors/Bias

Bias refers to a systematic error in the design, conduct, or analysis of a study that leads to an incorrect estimate of the
true effect.

Bias Types:

Selection Bias: Occurs when study participants are not representative of the general population.
• Example: Including only younger patients in a hypertension study may skew results.
Observer Bias (Measurement Bias): When researchers' expectations influence their observations or measurements.
• Example: A researcher expecting better results from Drug A may unconsciously interpret results more favorably.
Recall Bias: Happens when participants don't accurately remember past events.
• Example: In a study on diet and heart disease, patients who experienced heart problems may over-report unhealthy
eating habits.
Publication Bias: Studies with positive results are more likely to be published than those with negative or inconclusive
findings.
• Example: A journal may publish a study showing a new drug is effective but ignore one showing it's not.
Confirmation Bias: Tendency to interpret data in a way that confirms pre-existing beliefs.
• Example: A researcher who believes herbal medicines are effective may dismiss data that contradicts this belief.
Controls
• Placebo: A placebo is a non-active treatment used to compare the effects of a real treatment, ensuring any
effects observed are due to the treatment itself and not psychological factors.
• Example: In a clinical trial testing a new headache medication, some participants may receive a placebo (a
sugar pill) to determine if the actual medication is more effective than no treatment.
Purpose: To provide a baseline for comparison, Control psychological effects, Maintain blinding
Types:
• Placebo control – above example
• Active control –
• A group receives an already approved or standard treatment instead of a placebo.
• Purpose: To compare the new treatment with the best existing one.
• Example: A new diabetes drug is compared with metformin (an existing standard treatment) to see which is
more effective.
• Historical control
• Definition: The treatment group is compared with data from previous studies or patients (not a concurrent
control group).
• Purpose: Used when it's not ethical or feasible to have a current control group.
• Example: If researchers are testing a life-saving drug for a rare disease, they may compare current patients’
outcomes with historical records of untreated patients.
Randomization:
• Assigning subjects to groups by chance.
• The process of randomly assigning participants to different groups to ensure each participant has an equal chance
of being in any group. This helps eliminate selection bias.
• Example: In a drug trial, participants are randomly assigned to either the treatment group or the control group to
prevent any preconceived notions from influencing the assignment.
Methods:
• Simple randomization
• Each participant is assigned to a group purely by chance, like tossing a coin or using a random number
generator.
• Advantage: Easy to implement.
• Disadvantage: May result in unequal group sizes in small trials.
• Example: Assigning participants to Drug A or Drug B by flipping a coin.
• Block randomization
• Definition: Participants are divided into blocks (e.g., groups of 4 or 6), and within each block, random
assignment ensures equal numbers in each group.
• Purpose: To maintain balance in group sizes throughout the study.
• Example: In blocks of 4, each block will always have 2 in treatment and 2 in control, but the order is random
(e.g., AABB, ABAB, etc.).
• Stratified randomization
• Definition: Participants are grouped based on characteristics (e.g., age, gender, disease severity) and then
randomized within each group (stratum).
• Purpose: To ensure important traits are evenly distributed between groups.
• Example: Randomizing separately for males and females to ensure both groups have a similar gender
distribution.
Crossover Design
Definition: Participants receive treatments in a specific sequence.
• In this design, participants switch groups after a certain period. This allows each participant to act
as their own control.
• Example: In a crossover study to test the effectiveness of two different pain medications, one
group might receive medication A for the first period and medication B for the second, while
the other group starts with medication B and then switches to medication A.
Advantages:
• Fewer subjects needed
• Subjects act as their own control
Considerations:
• Washout period
• No carry-over effect
• Example: Comparing Drug A and Drug B in the same hypertensive patients with a 2-week
washout.
Blinding Techniques
• Blinding involves keeping participants and/or researchers unaware of which group the
participants belong to (e.g., treatment or placebo). This reduces bias in both data collection and
interpretation.
• Example: In a double-blind study, neither the participants nor the researchers know who
receives the actual treatment and who receives a placebo, preventing bias in treatment
administration and assessment.
Types:
• Single-blind: Participant unaware
• Double-blind: Participant and researcher unaware
• Triple-blind: Participant, researcher, and data analyst unaware
Purpose:
• Minimize bias
• Ensure objectivity