From BIO (a biotech trade organization), new data shows that over all trials, the 2006-2015 clinical development success rate was only 9.6% for phase I through approval. Some disease areas have had better luck than others, but overall the report is a very sobering reminder that clinical research is really, really, hard.
From John Ioannidis, a recent essay: “Why most clinical research is not useful.” Ioannidis has long been critical of research reproducibility and has advocated for reform. From the summary:
- Many of the features that make clinical research useful can be identified, including those relating to problem base, context placement, information gain, pragmatism, patient centeredness, value for money, feasibility, and transparency.
- Many studies, even in the major general medical journals, do not satisfy these features, and very few studies satisfy most or all of them. Most clinical research therefore fails to be useful not because of its findings but because of its design.
Perhaps current practices actually make clinical research harder than it needs to be…