Clinical Trial Eligibility Criteria
Broadening Eligibility Criteria to Make Clinical Trials More Representative
Eligibility criteria are necessary in clinical trials to define the patient population under study, isolate the potential effect of an investigational drug, and ensure that the trial is conducted safely. However, excessive or overly rigid eligibility criteria may impair the rate of trial accrual, restrict patient access to investigational drugs, and limit the ability to generalize the results to the broader population of patients who will ultimately use the drug.
New Recommendations Build on Ongoing Work to Expand Eligibility Criteria and Simplify Trial Operations
The American Society of Clinical Oncology (ASCO) and Friends of Cancer Research (Friends) jointly issued new recommendations to further efforts to broaden eligibility criteria in cancer clinical trials with the goal of making clinical trials more accessible to patients. The joint recommendations are detailed in a series of articles published in Clinical Cancer Research, a journal of the American Association for Cancer Research. The series provides a comprehensive examination of eligibility criteria for cancer clinical trials with recommendations to address five specific areas: treatment washout periods, concomitant medications, prior therapies, laboratory reference ranges and test intervals, and patient performance status.
Prior Eligibility Criteria Recommendations
In 2016, the American Society of Clinical Oncology (ASCO) and Friends of Cancer Research (Friends) began a joint project to develop and advance specific strategies to change the exclusionary nature of eligibility criteria. ASCO-Friends working groups composed of patient advocates, drug/biotech manufacturers, investigators, and regulators developed consensus recommendations for eligibility criteria on the following topics: 1) Brain Metastases, 2) HIV/AIDS, 3) Organ Dysfunction and Prior and Concurrent Malignancies, and 4) Minimum Age for Enrollment.
On October 2, 2017, an ASCO-Friends joint research statement and four supporting manuscripts on the topic were published in the Journal of Clinical Oncology. ASCO and Friends are now working to advance broad implementation of the recommendations.
On August 9, 2018, ASCO and Friends submitted jointly to the Food and Drug Administration (FDA) recommended language for five guidance documents on ways to broaden eligibility criteria for cancer clinical trials. FDA plans to review the ASCO-Friends recommended language as the agency finalizes draft guidance documents to release for public comment. ASCO and Friends will announce when the draft guidance documents are available for comment and develop comments for submission. Click HERE to read the full guidance document submission.
On October 12, 2018, Senators Dianne Feinstein (D-Calif.) and Johnny Isakson (R-Ga.), co-chairs of the Senate Cancer Coalition, and 27 of their colleagues urged the National Institutes of Health (NIH) to ensure racial and ethnic minorities are appropriately represented in clinical trials. Click HERE to read the full letter to Dr. Francis Collins, Director of the NIH.
ASCO is interested in staying abreast of steps that sponsors are taking to implement these recommendations. If your organization or network plans to update its trial protocols according to the ASCO-Friends recommendations or has already made similar updates, please consider emailing the ASCO CENTRA (Center for Research & Analytics) team to share your experience.
Journal of Clinical Oncology Special Series on Eligibility Criteria:
- Broadening Eligibility Criteria to Make Clinical Trials More Representative: American Society of Clinical Oncology and Friends of Cancer Research Joint Research Statement
- Modernizing Clinical Trial Eligibility Criteria – Recommendations of the ASCO-Friends of Cancer Research HIV Working Group
- Modernizing Clinical Trial Eligibility Criteria – Recommendations of the ASCO-Friends of Cancer Research Brain Metastases Working Group
- Modernizing Clinical Trial Eligibility Criteria – Recommendations of the ASCO-Friends of Cancer Research Organ Dysfunction, Prior or Concurrent Malignancy, and Comorbidities Working Group
- Modernizing Clinical Trial Eligibility – Recommendations of the ASCO-Friends of Cancer Research Minimum Age Working Group
- Re-Evaluating Clinical Trial Eligibility Criteria – Analysis of Investigational New Drug Applications in 2015
- Read the ASCO in Action post
- Download the ASCO-Friends Recommended Protocol Text and Guidance for Inclusion/Exclusion
- Download a PowerPoint slide deck that outlines the ASCO-Friends recommendations
- Read the submitted recommended language for the five guidance documents
- Read the press release announcing the submitted recommended language