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.

In 2016, 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 8, 2018, ASCO and Friends submitted recommended language for five guidance documents on ways to broaden eligibility criteria for cancer clinical trials to the U.S. Food and Drug Administration (FDA). The five guidance documents contain the recommendations published in the October 2017 JCO Special Series. FDA plans to review the ASCO-Friends recommended language as the agency finalizes draft guidance documents to release for public comment. ASCO and Friends will announce when the draft guidance documents are available for comment and develop comments for submission.

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 (October 2, 2017):

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

 

ASCO-Friends Submission of Recommended Language to U.S. Food and Drug Administration (August 8, 2018):

ASCO-Friends Submission - August 8, 2018

 

Additional Resources

Read the ASCO in Action post

Read the ASCO in Action Policy Issue Brief

Download the ASCO-Friends Recommended Protocol Text and Guidance for Inclusion/Exclusion

Download a PowerPoint slide deck that outlines the ASCO-Friends recommendations