Stock Watch: Protocol Changes Preface Poor Trial Outcomes

I remember an uncomfortable project team meeting as a commercial representative on a big pharma development program. The meeting was convened to discuss and remedy the dismal recruitment rate for a Phase IIb clinical trial. My clinical operations colleagues were wary about the work required to widen the recruitment criteria and increase the number of study sites so that more patients were enrolled. I on the other hand was concerned that broadening the inclusion criteria would also dilute efficacy across the new patient population. The conclusion of the discussion was to terminate the development because, as it was pointed out, very slow recruitment typically means that the original target patient population and commercial opportunity was much smaller than was first thought. Recently, companies have been attributing slow clinical trial recruitment to the pandemic, although Addex Therapeutics Ltd.’s extension and then termination of its clinical study could also just have been a euphemism for the drug’s lack of efficacy. (Also see "Syncona Biotechs Face Up To Trial Delays Over COVID-19" - Scrip, 23 March, 2020.)

I first saw the then private biotech company Sunesis Pharmaceuticals, Inc. in early 2001. Despite boasting a number of...