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Clinical Trials

This learning journey is designed to introduce the various phases of clinical trials, their ethical framework, human consent, study design, and trial endpoints. Selection bias and statistical aspects are also discussed in this journey.

Table of Contents

  1. Phase 1 clinical trials
  2. Ethical framework of clinical research
  3. Elements of consent
  4. Protection of human subjects
  5. First in human trials
  6. Phase 2 clinical trials
  7. What is an adequate and well-controlled study?
  8. Ethics and research design: preconditions for placebo control
  9. Historical controls and trial design for rare diseases
  10. Selection bias and randomization
  11. Trial statistical aspects
  12. Endpoints in phase II trial design: response rate
  13. Surrogate endpoint
  14. Oncology trial endpoints
  15. Phases 3 and 4 clinical trials

1. Phase 1 clinical trials

By Prof. Michael Kinch – Washington University in St. Louis, USA

An excerpt from Drug development: from discovery to manufacture

  • Play Phase 1 clinical trials

2. Ethical framework of clinical research

By Dr. J. Rosser Matthews – University of Maryland, USA

An excerpt from Historical and ethical issues in trial design

  • Play Ethical framework of clinical research

3. Elements of consent

By Prof. Dr. Christian Lenk – Ulm University, Germany

An excerpt from The history and foundations of medical research ethics

  • Play Elements of consent

4. Protection of human subjects

By Dr. Larissa Lapteva – Center for Biologics Evaluation and Research, FDA, USA

An excerpt from Development and regulation of cellular and gene therapy products: FDA perspective

  • Play Protection of human subjects

5. First in human trials

By Prof. Martin Edelman – Fox Chase Cancer Center, USA

An excerpt from Development of a cancer drug

  • Play First in human trials

6. Phase 2 clinical trials

By Prof. Michael Kinch – Washington University in St. Louis, USA

An excerpt from Drug development: from discovery to manufacture

  • Play Phase 2 clinical trials

7. What is an adequate and well-controlled study?

By Prof. Martin Edelman – Fox Chase Cancer Center, USA

An excerpt from Development of a cancer drug

  • Play What is an adequate and well-controlled study?

8. Ethics and research design: preconditions for placebo control

By Prof. Dr. Christian Lenk – Ulm University, Germany

An excerpt from Ethics and drug development

  • Play Ethics and research design: preconditions for placebo control

9. Historical controls and trial design for rare diseases

By Dr. Anne Pariser – National Institutes of Health, USA

An excerpt from Clinical trial designs for rare diseases 1: trial designs

  • Play Historical controls and trial design for rare diseases

10. Selection bias and randomization

By Prof. Lieven Nils Kennes – University of Applied Sciences, Germany

An excerpt from Detection of and adjustment for selection bias in randomized controlled clinical trials

  • Play Selection bias and randomization

11. Trial statistical aspects

By Prof. Martin Edelman – Fox Chase Cancer Center, USA

An excerpt from Development of a cancer drug

  • Play Trial statistical aspects

12. Endpoints in phase II trial design: response rate

By Dr. Patricia Tang – University of Calgary, Canada

An excerpt from Phase II trials

  • Play Endpoints in phase II trial design: response rate

13. Surrogate endpoint

By Prof. Geert Molenberghs – Universiteit Hasselt & KU Leuven, Belgium

An excerpt from Surrogate endpoints: from definition to meta-analytic framework 1

  • Play Surrogate endpoint

14. Oncology trial endpoints

By Prof. Martin Edelman – Fox Chase Cancer Center, USA

An excerpt from Development of a cancer drug

  • Play Oncology trial endpoints

15. Phases 3 and 4 clinical trials

By Prof. Michael Kinch – Washington University in St. Louis, USA

An excerpt from Drug development: from discovery to manufacture

  • Play Phases 3 and 4 clinical trials