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
- What is a clinical trial and why are they important?
- Phase 1 clinical trials
- Ethical framework of clinical research
- Elements of consent
- Protection of human subjects
- First in human trials
- Phase 2 clinical trials
- What is an adequate and well-controlled study?
- Ethics and research design: preconditions for placebo control
- Randomisation in clinical trials
- Statistical aspects of clinical trials
- Endpoints in phase II trial design: response rate
- Oncology trial endpoints
- Phases 3 and 4 clinical trials
- Trial registration and reporting guidelines
1. What is a clinical trial and why are they important?
By Prof. Allan Hackshaw – University College London, UK
An excerpt from Why clinical trials are needed
2. Phase 1 clinical trials
By Prof. Michael Kinch – Stony Brook University, USA
An excerpt from Drug development: from discovery to manufacture
3. Ethical framework of clinical research
By Prof. Allan Hackshaw – University College London, UK
An excerpt from Ethical and regulatory principles of clinical trials
4. Elements of consent
By Prof. Dr. Christian Lenk – Ulm University, Germany
An excerpt from The history and foundations of medical research ethics
5. 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
6. First in human trials
By Prof. Martin Edelman – Fox Chase Cancer Center, USA
An excerpt from Development of a cancer drug
7. Phase 2 clinical trials
By Prof. Michael Kinch – Stony Brook University, USA
An excerpt from Drug development: from discovery to manufacture
8. 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
9. Ethics and research design: preconditions for placebo control
By Prof. Dr. Christian Lenk – Ulm University, Germany
An excerpt from Ethics and drug development
10. Randomisation in clinical trials
By Prof. Riaz Qureshi – University of Colorado Anschutz Medical Campus, USA
An excerpt from Overview of clinical trials: history and trial elements
11. Statistical aspects of clinical trials
By Prof. Martin Edelman – Fox Chase Cancer Center, USA
An excerpt from Development of a cancer drug
12. Endpoints in phase II trial design: response rate
By Dr. Patricia Tang – University of Calgary, Canada
An excerpt from Phase II trials
13. Oncology trial endpoints
By Prof. Martin Edelman – Fox Chase Cancer Center, USA
An excerpt from Development of a cancer drug
14. Phases 3 and 4 clinical trials
By Prof. Michael Kinch – Stony Brook University, USA
An excerpt from Drug development: from discovery to manufacture
15. Trial registration and reporting guidelines
By Prof. Riaz Qureshi – University of Colorado Anschutz Medical Campus, USA
An excerpt from Overview of clinical trials: trial designs and reporting