Email : biostats@cmcvellore.ac.in

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Past Events

Clinical Trials - Design, Analyses, Interpretation and Reporting (Collaboration with UNC, USA)

December 14-18, 2015

Course co-ordinator & Lead Faculty: Dr. J. Visalakshi
Course Description

This course provides thorough knowledge in the principles and practice of clinical trials to study the effect of an intervention on health outcomes. This will include lectures, practicals, participant’s presentation, and group work.

Course Objectives

  • To impart knowledge in principles and practices of controlled clinical trials, through lectures and practicals
  • To impart the basic concepts in Ethical issues in research, Journal critique and in Systematic reviews.
  • To discuss and clarify the methodological challenges in the planning, conduct and analyses of a trial.
  • To impart the basic skills necessary in monitoring the trial and to develop a quality data management system.

Who should apply?

This course is tailored to researchers working in Pharmaceutical Industries, medical, allied health professionals, nonmedical faculty and researchers actively involved in trials, or teaching or in furthering their knowledge and skills in methodology.

Benefits

Each participant will be randomly allocated to a group and the group will be assigned a research question and given background materials to develop a protocol following GCP and CONSORT guidelines. Each group’s protocol development process will be facilitated by a mentor. Each group will be asked to present their protocol orally to the rest of the groups and faculty for discussion.

Rs 10, 000 per person for Academic Participants and
Rs 15,000 for Non Academic Participants
(Course kit, Lunch, snacks and tea will be provided)

Course Fee should be paid in full by December 11, 2014. Payment can be made by Demand Draft in favour of “Christian Medical College Vellore Association Account “, payable at Vellore. Course fees will not be refunded once the payment is done.


Accommodation:

Participants will have to bear their own expenses for travel, boarding and lodging. The Organizers will give Course kit, Lunch and Snacks. However the organizers may arrange basic accommodation with A/C facility in the college campus on request. Only limited accommodation available in the campus and priority will be given to the female participants on first come first served basis.


 

nMaster (Sample Size calculation software)

The cost of the nMaster software is fixed for Rs.2500/- for Academic / Government institutions and Rs.5000/- for Commercial.  However, those who would participate in this workshop from the Academic / Government institutions, a concession of Rs.1000/- will be offered to buy this nMaster software (price - Rs.1500/-).

Venue

Biostatistics Resource and Training Centre (BRTC),
Department of Biostatistics,
Christian Medical College,
Bagayam,
Vellore - 632 002.

The number of participants: limited to 45 admissions will be purely on first come first served basis.


Course Schedule

Building the Evidence

  • Introduction to Clinical Trials
        - Basic Principles
        - CONSORT guidelines                           
    •                                
  • Defining the Research Question - PICO
    •                            
  • Evidence from various research designs
         - Confounding in Research                          
    •                            
  • Phase I & Phase II Studies                        
    •                            
  • Introduction to research project
  • Journal Club exercise continued                           
    •                            
  • Design considerations
           - Phase III trials
           - Superiority vs non - inferiority hypotheses
           - Parallel, crossover and factorial designs
           - Adaptive Designs, Two stage Designs                           
    •                            
  • Examining the evidence
           - Journal critique guidelines
                                                               
    •                            
  • Introduction to research project group exercise
       Participants to refine their group's research question, review the evidence, elaborate their hypothesis and choice of study design  

Design and Conduct Issues

  • Ethics in Clinical Research
       - Ethics dictates design and conduct                                                           
    •                                
  • Design considerations
       -    Placebo vs usual care control arm   
       -    Masking - allocation concealment, maintenance
       -    Objectivity in data management                           
    •                            
  • GCP principles
       - Quality Assurance                           
    •                            
  • Laboratory Quality Assurance  
  • Intervention allocation
       -    Simple, stratified, cluster
       -    Randomization
       -    Blocking; permuted blocks
       -    Adaptive randomization schemes
       -    Optimized randomization 
       -    Exercise with Trial Data Analyzer 
  • Systematic Review and Meta – Analysis
       Participants to finalize their group’s study design, randomization scheme, and required sample size

Data Analyses and Monitoring Issues

  • Statistical methods for end-of- study analyses
         -    Descriptive analyses  - RR, NNT   
         -    Primary analysis of the primary study outcomes
         -    Analysis of crossover and factorial designs
         -    Survival analysis, logrank, Mantel-Haenszel                                                       
    •                                
  • Statistical methods for interim analysis
         -    Group-sequential methodology
         -    Stochastic curtailment
         -    Conditional power
         -    Statistical implications of early stopping
    •                            
  • Data and Safety Monitoring Boards
         - Role and responsibilities                           
    •                            
  • Case studies of early stopping
    •                            
  • Journal article critique by participants
          Participants develop their protocol's analysis strategy    

Data Analyses & Study Management

  • Types of Analyses
        -    Intention to treat (ITT)   
        -    Per protocol analysis (PP)
        -    As Treated Analysis                                                                              
    •                            
  • Handling missing data: imputations and challenges
    •                                                        
  • Secondary analysis
       -    Secondary analyses of the primary outcome
       -    Secondary outcomes               
       -    Side effects analyses
       -    Sub-group analyses: Uses and abuses                               
    •                            
  • Study management
       - Monitoring process
       - Coordinating protocol implementation                        
    •                            
  • Dealing with missing outcomes
       - LOCF, Imputations, Sensitivity analysis                                                      
    •                            
  • Analysing Change
        - Adjusting for baseline imbalance
        - Residual Confounding                    
    •                                                                                    
  • Necessary sample size
        - Exercises using nMaster2.0    
    •                            
  • Participants finalize their protocols & presentations                          

Cluster randomization & Group presentations

  • Cluster Randomization
        -    Concepts and Design Considerations
        -    Implications in the Analysis                                                                                                               
    •                            
  • Presentation of group's protocols