We write a lot of blog posts and produce long form reports on various biomarker-related topics. Those efforts have netted us several exciting collaboration opportunities. Recently, we had the opportunity to contribute to the largest study of clinical trials success rates in collaboration with BIO and Informa. We did not expect the findings to be as dramatic as they were. The study finds that, overall, clinical trials using biomarkers for patient selection are 3 times more likely to be approved.
The State of the Innovation IndustryThe report examines success rates across ~10,000 clinical programs by therapeutic area as well as three unique categories: rare diseases, chronic high prevalence diseases, and programs utilizing selection biomarkers. The results show dramatic differences between disease groups and modalities and will be presented during the session, "" at the BIO International Convention in San Francisco on June 6.
The key metric established in the report is Likelihood of Approval (LOA). LOA "denotes the probability of reaching FDA approval from the current phase, and is also expressed as a percentage. LOA is calculated as the product of each Phase Success probability leading to FDA approval. The n value associated with LOA is the sum of the n values for each Phase Success included in the LOA calculation."
LOA was first established in 2014 in a similar paper lead by Michael Hay of Informa and David Thomas of BIO. LOA has allowed Michael, David and their co-authors to investigate various dimensions of trials success, including biomarkers in this new report. The establishment of a base metric like LOA allows all of us to review our trial planning practices for effectiveness across dimension.
In support of the new report we will be holding a webinar on June 21st where John Audette, co-author of the report, will discuss the LOA methodology, how biomarkers contribute to clinical trials success and LOA in specific therapeutic areas.