The study looks at the impact of replicability issues in preclinical testing on the medical innovation process. The case study focuses on the development of liposomal chemotherapy, which exemplifies the difficulties of replicating experiments in preclinical settings. Despite those issues, liposomes achieved their translation in the clinic. To solve this puzzle, the case study introduces an original methodology to understand how the lack of scientific guidance is overcome to spur medical innovation. The results show that the involvement of researchers along the innovation process helped to accumulate knowledge in different experimental conditions. Properties and research practices involved in scientific experiments when liposomes were used as research tools helped to expand the knowledge base. Recombining those bodies of knowledge with clinical observations helped to overcome the uncertainty about the design to select. The resulting formulations built up on merging well-understood features of liposomes or to combine those with existing complementary technologies to enhance their therapeutic effect.
Blandinières, Florence (2019), Anatomy of the Medical Innovation Process – What Are the Consequences of Replicability Issues on Innovation?, ZEW Discussion Paper No. 19-011, Mannheim. Download