Change is in the Air: Part II

This is the second installment in a series on changes coming to the clinical research enterprise from John Neal, CPA, BS, CRCP, founder and CEO of PCRS Network, LLC, and member of the ACRP Board of Trustees. Read the first prediction here, or continue reading…

Prediction 2: Because sponsors are increasingly seeking efficiencies, and all stakeholders have an interest in minimizing the time required of, and the potential risk to, volunteers who participate in studies, there will be a decrease in the number of single drug studies in the future.

In place of single drug studies, collaborative, multi-sponsor studies will become more common. Multi-sponsor collaboration on studies is not a new concept. Going back as far as 1986 with theCardia Arrhythmia Suppression Trial (1), multiple drugs have been tested within the same study.

A more recent example is the Lung-MAP study, “a multi-drug, multi-sub-study, biomarker-driven squamous cell lung cancer clinical trial that uses state-of-the-art genomic profiling to match patients to sub-studies testing investigational treatments that may target the genomic alterations, or mutations, found to be driving the growth of their cancer.” (2)

“You are going to see more collaborative trials occurring when multiple sponsors studying the same disease will work together to create one protocol.”

Jeffrey Kasher
Chairman of the Advisory Board of DrugDev
President of Patients Can’t Wait, LLC

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