Industry Warily Approaches Innovative Clinical Trial Design

Innovative Clinical Trial Design Survey Report

While clinical trial industry leaders are intrigued by the prospects for leveraging innovative trial design as a vehicle to drive cost savings and improve patient-centricity, more than half of the respondents to a new survey said they do not have a dedicated team or department devoted to it. And they aren’t sure they’ll ever commit that kind of resource to what many view as an unproven concept.

Survey participants from service provider companies were far likely to have such a person or department when compared to academia, according to the “Innovative Clinical Trial Design Survey Report” from SCORR Marketing and Applied Clinical Trials. Where 67% of service providers reported having a person, department, or team specifically tasked with innovative trial design, just 33% of academic medical center respondents could make the same claim.

Nearly 40% of service providers said their company implements new clinical trial design by therapeutic area. C-Suite/VP responders were more likely to say implementation was a company-wide initiative (54%) as opposed to being based in a therapeutic area.

Just over 40% of respondents selected adaptive trials—defined in the survey as those where there is flexibility to alter the study based on how patients are responding—as proving the best potential return on investment (ROI). Basket studies were named by about 25% of the respondents as offering the best ROI. The survey defined basket studies as “trials that allow for testing one drug on different subgroups.”

Nearly three-quarters of respondents were familiar with adaptive studies. Most groups—ranging from organization type to company size—were more familiar with adaptive studies than they were with any other innovative clinical trial designs.

“There is a cautions optimism about the future of study innovations,” according to the report. “The caution may stem from uncertainty about whether these innovations have met operational and financial expectations.” Two-thirds of respondents either said they were uncertain these new designs accomplished what they had hoped, or said outright that the innovations failed to meet their hopes.

A plurality of respondents predicts their company and the industry will implement more study innovations in the next two years. However, a sizeable minority believes the increase will be slight. “Respondents believed there will be broader adoption of innovative designs in their industry [as a whole] than in their own company,” the survey summary said.

For more information about the survey (registration required), visit:

Author: Michael Causey