Study Design and Analysis of Clinical Trial

  Module 1:

   ” Part 1 – Estimation of Quality of Life Outcomes in Clinical Trials and Consideration for                                        Innovative Trial Design Where we are and Where Should we go ?”

                – How Far Have we Come ?

                – These were the Beginnings

                – Attempts to Interpret these Results

                – How Valuable is the Global QOL Measure ?

                – Umbrella Trials

                – Basket Trial

                – Bayesian Analysis

                – Platform Trial

                – STAMPEDE Trial

                – Multiple Testing – Master Protocol

                – Concurrent Control

   Part 2-  Drug Development , How did we get Here?

               – Where is here ?

               – How do we get out of here?

                 What is Response – Adaptive Randomisation?

               – RAR Timeline Since 1933

               – Where to Read about the Debate ?

              – Why Another Review Paper Now ?

              – Some Basic Ideas and Notation

              – Comparing RAR

              – How to Classify RAR ?

              – Questions

              – Does RAR Reduce Power?

              – Questions

            ” – Does RAR Increase Chances to Receive an Inferior Arm ?”

 Part 3 – Conduct

             – Summary

             – Broad Aim of Health Economics

             – The Health Service Dilemma

             – Informing Decesions About Opportunity Costs

             – What is Economic Evaluation ?

             – Key Points About Economic Evaluation

            “- Why Have An Economic Evaluation as Part of a Trial ?”

             – Health Economics Methods

             – Limitations of Trials for Economics Evaluation

             – Case Study

             – Costing Methods

             – Use of Trials in Modeling

             – Scope of Modeling

   Part 4 – Global Score Categorization

            – QOL Concept

            –  Breath of Stimulation Effect (BOSE)

             – Combining QOL and Clinical Outcomes

             – Duration of Good QOL

            “- Minimum Clinically Important Difference (MCID )in Each QOL Domain “

             – Summary

   Module 2:
 

   “Part 1 -Joint Longitudinal and Survival Modelling in Clinical Trials “

               – Why Joint Modelling

               – Illustration

               – How Data looks

               – Survival Data Exploration

               – Longitudinal Data Exploration

               – Longitudinal Data Prediction

               – Structure of a Joint Model

                – Joint Modeling Packages

                – Bayesian Joint Modeling

                – Dynamic Prediction

                 – Joint Modeling  with Bayesian

                 – Joint Modeling  with MLE

                – Dyanamic Prediction by Classification

                – Dynamic Prediction by ML

                – Reference

     Part 2 –  Discussion

    “Part 3 – IPIROC (Intermittent PARP Inhibitor in Ovarian Cancer)”

               ” – Road Map to Safe and Well  Design DE – Escalation Trials of Systemic                                      ADjuvant Therapy for Solid Tumors “

                “- IPIROC in as a Strategy to reduce PARPi Related Morbidity “

                “- KPI(Key Performance Indicator) for Successful Implementation Research                              Better Clinical Trials: EASE “

                  – RCT (Randomized Control Trial) Approach

                  – Ovarian Cancer Research in LMICs

                  – Breaking Barriers and Boundaries

  “Part 4 – IPIROC Series (Academic Studies -Innovative Study Design/Endpoints)”

   Part 5 – PROVAT (Project Ovarian Tumor Translation)

              – PARP Inhibitor Use is Ovarian Cancer

              – Evidence Generation and Endpoints

              – Patient Involvement In study Design

  “Part 6- BARDS ( Biostatiscian and Research Decision Science )”

                – Roles and Responsibilities

                – Research Project

                – Logistics Regession

                – AACTREVEAL

                – AACTREVEAL R Packages

                – C-QCT Analysis of Covid 19 Drug (Molnupiravir)

  “Part 7 – As a Center for Advanced Research for Methodological Studies in Cancer”

 

  Module 3: “Part 1 – Roles and Challenges of missing Data in Clinical Trials “
 

                      – Pattern of Missigness

                      – Mechanism

                      – Handling

                      – Imputation

                      – Methodological Work

                      – Recent Advances 

                      – Summary

   Part 2- Genomics – Driven Clinical Trials

               – Oral Cancer

   Part 3- Traditional Dose Escalation Trial Design

              – Available Dose Findings Methods

              – The Evolution Process

              – the 3+3 Method

              – Model Based Dose Finding Methods

              – Modified Toxicity Proability Interval (mTPI)

              – Bayesian Optimal Interval Design (BOIN)

              – The Internal Design

              – Project Optimum

              – BOIN Design Method

              – BOIN vs BOIN12

  “Part 4 – High miR 324 -5p Expression Predicts Poor Survival in TP53-Mutated Cancers”

              – Overall Age Standardised Relative Survival (ASRS)

              – Outcomes

   Part 5- Future Plan

             – Recurrent Cervical Cancer

             – EWS Every Women Study 

           “- DetEC (De- Escalating Treatment in Endometrium Cancer Patient of the Indian                     Subcontinent”

          ” – Studies on Functional Heterogenecity of TP53  Mutations in Ovarian Cancer “

Certification in FCPM [Online]
Duration of Course: 8 Week
Schedule: 4 hours a week  
                 (2 days each week)

Bridge Course in FCPM – [Offline]
Duration of Course: 8 Week
Schedule : 4 hours a week
                   (2 days each week)

Batches Starting From August 2024
Enroll now for early bird offers (10% discount in both modes)
Perks of Offline Course

• Role Play
• Get to work on live projects
• Face-to-face guidance by PM
• Clinical on-site exposure