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.


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