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Clinical Research Design and Statistics Practice Training Program

Program Overview

In the face of emerging research issues and challenges, such as initiation of unclear clinical trials, the needs for rigorous research design, inefficient 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 most urgent methodological experts in the world .

Now,along with the expansion of our forum and an increasing number of audiences who are eager to systematically learn more clinical trial by participating in online webinar training for clinical research. Therefore, we would like to initiate a training certificate program for global audience to learn the standard and advanced designs of clinical trials and related clinical research methodology.

Program Teaching Model

ELearning:  We offer 40 online classes with each class consisting a talk for 1.5 hours and a case study component that last 30 minutes.

 

Webinars:   We offer bi-weekly webinars to facilitate learning processes.

 

Workshop:  We offer 20 one-hour online workshops to focus on project discussion.

 

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: Principle of Clinical Trial Design

  • Topic 1: Selection of Endpoints

  • Topic 2: Sample Size Calculation

  • Topic 3: Stratification and Randomization

  • Topic 4: Blinding and Trial Classifications

  • Topic 5: Patient Enrollment

  • Topic 6: Control Group Design

Module 2: Phase One of Clinical Trial Design

  • Topic 7: Phase I Design Part 1

  • Topic 8: Phase I Design Part 2

  • Topic 9: Incorporate Historical Data and Real World Data into Phase I Trials

  • Topic 10: Drug Combination Trials

  • Topic 11: Trials with Late-onset Toxicity

  • Topic 12: Finding Optimal Biological Dose for Targeted Therapy and Immunotherapy

Module 3: Phase Two and Phase Three of Clinical Trial Design

  • Topic 13: Phase II Designs (Simon BOP2...) Part 1

  • Topic 14: Phase II Designs (Simon BOP2...) Part 2

  • Topic 15: Design Phase III Trial

  • Topic 16: Phase I-II Seamless Trial Designs

  • Topic 17: Phase II-III Trial Designs

  • Topic 18: Basket Trials and Umbrella Trials

  • Topic 19: Interim Analysis

  • Topic 20: Adaptive Design

Module 4: Clinical research topic selection, clinical research data mining, and SCI paper writing

  • How to find research ideas and select research topics from clinical duties.

  • How to use public datasets to conduct high-quality clinical research.

  • SCI paper-writing techniques.