Workshop Summary:
This workshop covers introduction to clinical trials. At the end of this workshop participants will learn how to design a randomized clinical trial, randomization, concealment, blinding, different phases of trial, sample size estimation, protocol development & registration, ethical consideration, good clinical practices, data management & coordination, recruitment & adherence, RCT data analysis (Interim Analysis, final analysis, Intention to treat analysis, per protocol analysis) reporting results of RCT, interpretation and dissemination of results.
Session 1. Introduction to Clinical Trials
- Introduction
to clinical trials and study protocols
- Brief
overview study protocol features
- Research
questions/hypotheses (FINER criteria)
- Intervention
and study endpoints (primary, secondary, & surrogate)
- Study population
- Importance
of Randomization
- Types
of Randomizations
- Allocation
Concealment
- Blinding
or masking
- Types
of masking
- Placebo
controls selection
Session 2. Phases of Trials and ethical practices:
- Overview
of Phase I studies
- Overview
of Phase II studies
- Introduction
to Phase III trials
- Protocol development guideline
- Ethical
issues in clinical trials
- Informed
consent guidelines
- Good
Clinical Practice
Session 3. Sample size, data management and coordination
- Sample
Size concepts
- Sample size estimation
- Clinical
research forms & data collection
- Data
management & quality assurance
- Study
monitoring
- Understand
the role of a data and safety monitoring
- Clinical research forms & data collection
Session 4. Study coordination, recruitment, adverse events and adherence
- Recruitment
and retention
- Barriers
to participation in research
- Adverse
event reporting
- Adherence
- Early
termination of trials
Session 5. Application of appropriate statistical methods in design and analysis of a trial / Reporting and interpreting study results & multicenter trials:
- Interim
Analysis
- Final
analysis
- Intention
to treat
- Per
protocol
- Loss of follow-up
- Protocol
deviations
- Study
closeout
- Multicenter
trials
- Reporting
study results
- Authorship guidelines in protocol
- Protocol
registration
