According to at least one highly respected mind, if one does the same thing over and over again and expects different results, they are in fact insane. Now, with the cost to develop drugs skyrocketing and many of the underlying causal factors understood yet not addressed—after decades—we could extend this classical observation to the clinical trials process and its sponsors. And then ask the question: Are pharma, CROs, and research centers insane?
Afterall, with the cost of developing a new drug totaling $2.6 billion—and over two-thirds of this allocated to the clinical research process—the sponsors, their CROs, and research centers keep trying to develop drugs in the same way—over and over. And, within the clinical research process, patient recruitment was and has been the number one bottleneck contributing to countless clinical trials delays. These delays can result in costs of up to $8 million per day in lost future revenues to the sponsor paying for the research.
Making matters worse, when sponsors and sites actually find patients, 40% of the time they drop out—leading to more delays. This author has been involved with patient recruitment and clinical trials since ...
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