Develop Usable Comparative Effectiveness Data via Investigator Initiated Trials

Research currently underway here at CEI shows that pharmaceutical companies get usable comparative effectiveness data from only 11% of the investigator-initiated trials that they fund. There is a clear opportunity for companies to leverage existing thought leader relationships and investigator initiated studies efforts to gather highly valuable CER data.

R&D programs have plenty of questions left to answer once a drug is approved. While clinical teams work to expand a drug’s label, post-marketing and investigator initiated studies teams are positioned to collect additional safety, outcomes and comparative effectiveness data. Both government and private payers always want more information on these three points when making reimbursement decisions.

Medical science liaisons serve as the perfect conduit to convey companies’ investigator-initiated trials interests with thought leaders. “Soliciting” investigator-initiated study proposals from physicians is frowned upon, but MSLs are able to discuss potential research topics of interest. Better yet, the philosophy behind comparative effectiveness research appeals to physicians’ instinct to search for the best possible treatment for their patients.

Not all comparative effectiveness trials require new patients and huge budgets, as more investigator initiated trials teams are encountering proposals for retrospective studies. Retrospective studies evaluate comparative effectiveness using large patient databases, and they are ideal for drugs near the end of their lifecycle, a point at which relatively little IIS funding is usually available. Retrospective studies add important data at a low cost — sometimes less than $20,000 — while fostering thought leader relationships to increase the overall ROI on investigator-initiated trials.

From Ryan McGuire, project leader of the soon-to-be-published Investigator Initiated Trials study.
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