It's no secret that drugmakers often fail to hit patient-recruitment targets for their clinical trials, but they might never say which study sites fell short in enrolling patients. To offer greater transparency of the problem of poor patient enrollment, researchers want full disclosure of whether investigators made their enrollment numbers on registries such as ClinicalTrials.gov.
In an article published late last month in the open-access journal PLoS Medicine, the authors made a case for their call to action. For starters, the authors wrote, poor recruitment causes many trials to shut down before the studies are completed, and companies often don't disclose via online registries that are available to the public where recruitment fell short. The authors propose that sponsors should reveal recruitment targets of all study investigators at the start of a study and whether those goals were achieved. They should also make clear any issues that impacted patient recruitment.
"This information will be of interest to different stakeholders such as patient organizations, sponsors, and MCT networks," the paper's authors wrote. "Disclosing all site investigators' recruitment figures could prompt queries to the sponsor from the scientific community about regional subgroup analyses, to assess if ethnic or standard-of-care differences have an impact on treatment outcomes."
- here's the PLoS Medicine article
- check out the Pharma Times' report