They allow quick termination of non-viable drug candidates. Alternatively, if no negative findings are identified, these approaches considerably increase the value of the asset. In addition, Phase-0 approaches allow testing in patients at the FIH stage. This may provide patient data up to 2.5 years prior to traditional approaches. In other words, Phase-0 including Microdosing approaches provide quick Venture Capital support to make key developmental decisions at high-stakes phases of clinical development.
It would be reasonable to assume that these same principles would be readily followed by mainstream pharmaceutical industry. However, these 'truth-seeking' strategies often are in conflict with a culture that encourages moving an asset forward in development. Such 'progression-seeking' culture is encouraged through incentive structures in many industry entities. It has been reported extensively in the literature with some companies already applying corrective measures (Cook et al., 2014, Lendrem et al., 2015, Peck et al., 2015, Morgan et al., 2018).