As the clinical research industry faces mounting pressures from funding constraints, evolving payer expectations and technological disruption, David Burnham, senior vice president of clinical solutions at Syneos Health, says the time has come to rethink the status quo.
Burnham emphasized that the traditional path of demonstrating clinical and statistical significance is no longer enough to bring therapies to market. “You now need payer significance as well,” he said, urging companies to engage payers early in the development cycle to ensure treatments are not only approved but reimbursed.
Burnham also highlighted the growing role of tech-enabled innovation in clinical trials. Digital biomarkers, wearables and patient-centric endpoints are reshaping how studies are designed and managed. To keep pace, CROs must become “super users” of these technologies, requiring new models of vendor oversight and a more specialized workforce.
“Project managers need to evolve,” Burnham said. “They must understand specialty vendors and anticipate challenges before they escalate.”
Patient and site burden is another critical factor. Burnham stressed the importance of designing protocols that reflect the real-world experiences of participants. Tools like social listening and patient advisory boards are helping sponsors better understand and incorporate patient voices into study design.
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