FDA Report on Enrollment Criteria for Drug Clinical Trials Points to Barriers, Strategies
Posted 22 August 2018 | By
The US Food and Drug Administration (FDA) issued a new report Wednesday that summarizes a recent public workshop aimed at evaluating inclusion and exclusion criteria in pharmaceutical clinical trials.
Conducting the evaluation is aimed at addressing current research gaps in drug development.
“Enhancing inclusion and encouraging greater diversity in clinical trial populations is a priority for regulators, sponsors, investigators, and patient advocates,” FDA’s summary report
The report describes findings regarding ethical and scientific considerations that may lead to the exclusion of certain patients in trials. These relate to patients with organ dysfunction or multiple chronic conditions, older or pediatric patients, as well as pregnant or lactating women.
“Exclusion of such patients provides no information about a drug’s benefits and risks in such patients, but they may use the drug if it is approved,” the report states. “Therefore, it is important to consider on a case-by-case basis whether such exclusions are truly necessary.”
Workshop participants also highlighted several strategies to improve the way in which eligibility criteria are established and to increase enrollment in clinical trials, according to FDA. These include better communicating set eligibility criteria to patients, providers and clinicians.
“There may be longstanding eligibility criteria practices that unnecessarily limit eligibility for certain patient populations,” FDA said. “In designing eligibility criteria, sponsors, investigators, and regulators should avoid assumptions and revise criteria lacking clear scientific justification.”
In addition to improving transparency around eligibility criteria and reevaluating current practices for determining exclusion or inclusion, the report points to conducting more trials with alternative designs (i.e. pharmacokinetic modeling and open-label safety studies) and using data from expanded access programs as other potential strategies for increasing clinical trial enrollment.
“Data collection in expanded access programs may require standardized protocols, as well as a significant amount of interaction between regulators and sponsors,” FDA said.
Further, the report cites geographical distance, financial burdens and transportation considerations as other challenges and barriers outside of inclusion and exclusion criteria.
Convening the public workshop, held 16 April 2018, and publishing the report fulfill the requirements set forth under the FDA Reauthorization Act of 2017
“The report is intended only as a summary of the workshop discussions and does not provide guidance or reflect FDA’s current thinking on this subject,” FDA said in a Federal Register notice