17 May 2021
Setting it Straight: Interventional trials - preclinical to phase I
Last week’s discussion (#56) addressed the basic ground rules for designing an acceptable (to ethics and regulatory committees) double-blind, randomised, interventional clinical trial, the gold standard for drug or vaccine evaluation and eventual approval for community use. Prior to that, (#54) we also looked a little at the complementary observational trial strategy, along with relating some personal experience of enrolling as a clinical trial participant. That included the need to sign an informed consent form that clearly lays out any known risks, what will be required of you with regard to providing samples of blood and other body fluids or solids, and the information that you will receive at the end of the trial.