The seminar discusses various clinical study research designs, focusing on observational and experimental methods. It covers descriptive studies (including case reports, case series, and cross-sectional studies) and analytical studies (case-control and cohort studies), as well as experimental designs such as randomized clinical trials. Additionally, it highlights types of randomization and phases of clinical trials.

1. SEMINAR ON
Clinical study research designs
Name:
Dharnish GS
M. Pharm I year
Department of Pharmacy Practice
JSS College of Pharmacy, Mysuru
JSS COLLEGE OF PHARMACY. MYSURU

2. AGENDA
• Introduction
• OBSERVATIONAL STUDY DESIGN
• EXPERIMENTAL STUDY DESIGN
• CONCLUSION
• REFERENCE
JSS COLLEGE OF PHARMACY. MYSURU

3. Introduction
• A study design is a scientific method that a researcher follows to assess the
association between an exposure and an outcome.
• It depends on the subjects that are selected, observed followed and studied.
• In clinical research, there are two broad categories of study designs, mainly
observational and experimental.
.
JSS COLLEGE OF PHARMACY. MYSURU

4. Descriptive studies
the main objective of the research is to describe the main features of the population. There are
different types of descriptive studies, mainly Case reports, Case series, and Cross-sectional study.
Case report
It is a report that documents unusual medical occurrences that can represent the first clue in the
identification of new diseases or adverse effects of exposures (based on one patient). It includes a
summary of the disease, such as the presentation signs, symptoms, diagnostic studies, treatment
course, and outcome.
JSS COLLEGE OF PHARMACY. MYSURU

5. Case series.
It is a collection of different case reports, thus based on more than one patient.
Cross-sectional study
It is a study in which data is collected at one point in time and which reflects
information on prevalence of outcomes.
JSS COLLEGE OF PHARMACY. MYSURU

6. Analytical studies•
These are studies designed for research with the main C objective being beyond
description, and where a specific association is assessed. The main types of analytical
studies are Case-control study Cohort study
Case-control study
It is a study where participants are recruited based on their outcome status; a group
having the disease and another who are disease-free. Information on past exposure is
collected and compared between the two groups
JSS COLLEGE OF PHARMACY. MYSURU

7. Cohort study It is a study where participants are recruited pased on their exposure
status; a group having the exposure under study, and another group who are exposure-
free, The subjects are followed in time to observe the occurrence of the outcome in
both groups.
JSS COLLEGE OF PHARMACY. MYSURU

8. Experimental study designs
Experimental studies are those studies where an investigator allocates different exposures to subjects
based on different criteria, mainly in a random fashion, and consequently, the investigator is no longer
observing the subjects, but is actually carrying out an experiment on them., The main type of
experimental studies is the randomized clinical trials.
JSS COLLEGE OF PHARMACY. MYSURU

9. Randomized clinical trail
RCTs are quantitative, comparative, controlled experiments in which investigators study two or
more interventions in a series of individuals who receive them in random order. The RCT is one of
the simplest and most powerful tools in clinical research.
JSS COLLEGE OF PHARMACY. MYSURU

10. TYPES OF RANDOMIZATION
1. RANDOM ASSIGNMENT:
Flip a coin"Heads"-T x A
"Tails“ T x B
‣ Roll a six-sided dice
Even number T x A
Odd number- Tx B
JSS COLLEGE OF PHARMACY. MYSURU

11. 2. BLOCK RANDOMIZATION:
• Subjects are divided into blocks' and randomization is carried out in each blocks.
• Ex; for two treatments and a block size of four, two of every four consecutive patients
would receive the experimental therapy and the other two would receive control therapy.
EECC,ECEC, ECCE, CCEE, CECE.
STRATIFIED RANDOMIZATION:• It may be important to ensure that the treatment
and control groups are balanced on important prognostic factors that can influence the
study outcome (e.g., gender, ethnicity, age, socioeconomic status). • Before doing the
trial, the investigator decides which strata are important and how many stratification
variables can be considered given the proposed sample size.
JSS COLLEGE OF PHARMACY. MYSURU

12. Clinical trial
• PHASE - 1- Human pharmacology and safety
• Phase 2- Therapeutic exploration and dose ranging
• Phase 3: Therapeutic confirmation/ comparison
• Phase IV: Post-marketing surveillance/ studies
JSS COLLEGE OF PHARMACY. MYSURU

13. THANK YOU!
JSS COLLEGE OF PHARMACY. MYSURU