Quality & Compliance: Lesson Learned From the TeGenero First-in-Man Phase 1 Clinical Trial

| 01 May 2008

The first article in this series discussed the phase 1 clinical trial reviewed and cleared by the UK Medicines and Healthcare products Regulatory Agency (MHRA) that nevertheless resulted in six research subjects suffering life-threatening injuries.

It is crucial that the lessons learned from this tragedy result in practical operational changes within the pharmaceutical industry, especially in the small company setting where pressures to move compounds through the development pathway quickly are tremendous. This article examines the lessons that must be learned from this experience. Part 3 will examine the role of risks, the research subject and the part that can be played by regulatory professionals in ensuring that research subjects are adequately informed and consented before participating in clinical trials.


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