Four Ways Academic Organizations Can Boost Clinical Trial Results Reporting
Many clinical trial results go unreported, which could lead to poor decisions on whether new drugs or therapies should hit the market. As federal requirements for reporting results of clinical trials expand, academic research organizations struggle to comply. A recent survey suggests these organizations could boost compliance right away by improving oversight, educating researchers, and holding them accountable.
The Food and Drug Administration Amendments Act of 2007, the National Institutes of Health, and the International Committee of Medical Journal Editors have recently implemented broader and more stringent regulations to ensure appropriate sharing of clinical trial results. The organizations require more types of clinical studies to be registered and to post results on ClinilcalTrials.gov, a publicly accessible database. [For a detailed list of requirements, see Box 1 of the study.]
Academic organizations have performed worse than their industry counterparts when it comes to registering clinical trials and reporting study results. But the National Clinical Trials Registration and Results Reporting Taskforce, an independent group of researchers who conducted the survey, hope to change that. Their study, detailed in BMC Medicine, is a first step toward helping academic organizations streamline their efforts to comply with the new requirements.
Survey responses from 366 active ClinicalTrials.gov accounts, representing the vast majority of clinical trials registered by academic organizations in the U.S., suggest academic organizations provided little oversight on clinical trial registration and results reporting. Most often, the responsibility to register, report and monitor fell to individual investigators and/or administrators. Most survey respondents indicated that their organizations allocate staff for these tasks, but only for an average of 0.08 full time equivalents.
Many academic organizations also lacked policies supporting clinical trial registration and results reporting. Less than half of survey respondents reported that their organizations had registration policies and just over one-third had policies on reporting study results. Policies also varied, with only 18% allowing organizations to penalize investigators who fail to register or report results of their clinical trials.
The Taskforce recommends four steps that academic organizations can take today to improve compliance:
- Educate investigators on requirements and available resources
- Implement policies and procedures that support trial registration and reporting
- Monitor for non-compliant trials and help those investigators meet the requirements
- Hold investigators accountable if they fail to meet requirements
As a fifth, longer-range recommendation, academic organizations could also centralize administration of their clinical trial registration and reporting. Rather than reporting through multiple ClinicalTrials.gov accounts and administrators, it could save time and resources to manage these tasks through a single account and administrator.
To learn more, read the full study.
As a member of the National Clinical Trials Registration and Results Reporting Taskforce Survey Subcommittee, UR CTSI’s Director of Research Services, Carrie Dykes, Ph.D., helped develop the survey and contributed data to it.
Susanne Pritchard Pallo |