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Certification Program

Program Overview

In the face of emerging research issues and challenges, such as initiation of unclear clinical trials, inefficient study supervision and implementation, unreported or unregulated results, a group of outstanding clinical research experts at major medical schools in the United States formally launched a series of clinical trial training courses and seminars sponsored by Academy of Clinical Research and Study, aiming to systematically train the internationally standardized methodology of clinical trials and related research and to promote the cultivation of the urgently-needed methodological experts in the world.


Now, along with the expansion of our forum and an increasing number of different types of audiences who are eager to systematically learn clinical trials by participating in online webinar training of clinical research, we would like to initiate a Cancer Clinical Trial Design for immunotherapy and Scientific Publication Forum for a global audience to learn the standards and advanced designs of clinical trials and related clinical research methodology

Program Teaching Model

ELearning:  We offer 2 online E-learning sessions each month.

 

Webinars:   We offer one webinar to facilitate learning processes.

 

Workshop:  We offer 2 workshops to focus on project discussion.

 

Q&A: We offer 2 Q&A sessions to help with individual questions upon subjects.

 

Get final Certificate:  When the candidate finishes at least one design project and get instructor approval, the candidate is qualified to receive the final Certificate.

 

We are inviting elite researcher and professors from University of North Carolina at Chapel Hill, The University of Texas MD Anderson Cancer Center, Northwestern University, Duke University and beyond, to join the certification program as instructors and mentors. We hope to promote the internationalization of clinical research and aim to train future clinical research methodology talents and research clinicians to meet international standards.

Program Module Overview

Module 1: Phase I clinical trial design

  • Single agent trials for immunotherapy   

  • Drug combination trials for immunotherapy  

  • Trials with late-onset toxicity for immunotherapy    

  • Finding optimal biological dose for targeted therapy and immunotherapy

  • Phase 1 designs for immunotherapy

  • Incorporate historical data and real world data into phase I trial for immunotherapy

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Module 2: Phase 2 clinical trial design

  • Selection of endpoints for immunotherapy

  • patient population selection design (inclusion and exclusion criteria) for immunotherapy

  • Randomized phase 2 trial designs for immunotherapy

  • Basket trials and umbrella trials for immunotherapy （ master protocol trials basket umbrella and platform ）

  • consideration about accelerated approval

  • Phase 1-2 seamless trial designs for immunotherapy  

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Module 3: Phase 3 clinical trial design

  • Interim analysis (futility and efficacy) and group sequential design for immunotherapy   

  • Power and sample size calculation                   

  • Stratification and randomization for immunotherapy 

  • blinding (single-blind, double-blind, open-label), trial classifications, trials structure (single-arm, double-arm, multi-arm)                                   

  • Phase 2-3 trial designs

  • Design phase 3 immunotherapy trials

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Module 4: Clinical research topic selection, clinical research data mining, and scientific publication in real world study for immunotherapy 

  • Clinical trial paper publishing - case study 1

  • Clinical trial paper publishing - case study 2

  • Clinical trial paper publishing - case study 3

  • Clinical trial paper publishing - case study 4

  • Clinical trial paper publishing - case study 5

  • Clinical trial paper publishing - case study 6

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