PCL102H1 Lecture 11: Phase 1 Clinical Trials and Biomarkers
7 Mar 2017
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How do you decide whether to participate in a clinical trial: discuss the trial with the doctor and other friends and family, contact previous trial participants, consider other factors such as time commitment, risks and benefits. Phase 1 questions: what doses can be tolerated, what doses are safe, how does the drug move in the body, absorption, distribution, metabolism, elimination, these results guide dosing in phase 2. Phase 1 clinical trial disaster 2016: drug under development for treating anxiety, between july 2015 and october 2015, sad study for 64 volunteers to test drug with doses increasing from. In november 2015, a series of multiple dose trials began, each enrolling 8 subjects -> the first group received 2. 5mg daily, the second received 5mg etc. > the accident happened in the 5th group which received 50mg daily which was the highest dose: one person was brain dead and 5 were in hospital.
