Many investigational products previously pursued by biopharmaceutical industry have value for small patient groups. It is as important to glean value from existing products and knowledge as it is to pursue new treatments. At a minimum, this could help the industry proactively face the issue of diminishing returns.
Drew Smith’s article on rising cost and declining discovery rates being the hallmark of resource depletion is another call to action for developing a learning system to accelerate clinical development. Resource depletion may indeed be contributing to increasing development timelines, rising cost, and a decreasing return on investment for biopharmaceutical companies. It is also a likely contributor to increasing study complexity. When the impact of resource depletion is compounded by regulatory fundamentalism[1] and conflicted partners the need and value of a new approach to the conduct of clinical trials becomes clear.
Analogies to gold mining is on point. When all of the fist-sized nuggets have been found and the gravel and sand is getting more expensive to recover, opportunities to sift through the gravel and sand to find value becomes the next opportunity. A learning system will enable precision medicine and the treatment of individuals in ways traditional development is unlikely to realize.
A learning system would add further value by allowing biopharmaceutical companies to derive value (i.e., sales) from products previously studied. Many investigational products previously pursued have value for small patient groups. It is as important to glean value from existing products and knowledge as it is to pursue new treatments. At a minimum, this could help the industry proactively face the issue of diminishing returns as described by Kelvin Stott.
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[1] The term “regulatory fundamentalist” was coined by David Stewart in the Journal of Clinical Oncology on June 10, 2010 (Stewart, D., 2010, Equipoise Lost: Ethics, Costs and the Regulation of Cancer Clinical Trials, Journal of Clinical Oncology, v. 28, pp. 2925-2935).
