Clinical Trial Eligibility Criteria
Broadening Eligibility Criteria to Make Clinical Trials More Representative
Overly restrictive eligibility criteria in cancer clinical trials limit patient access to potentially life-saving treatments and can impede progress. Friends of Cancer Research (Friends) advocates for broader and more inclusive eligibility criteria to enhance the generalizability of trial results, reduce health disparities, improve trial efficiencies, and ultimately improve outcomes for patients with cancer. Friends convenes patient advocates, researchers, regulators, and industry stakeholders to reevaluate and develop recommendations for broadening eligibility criteria to support more inclusive and impactful cancer clinical trials. Visit us on LinkedIn and Twitter to stay up to date with #Friendsclinicaltrials.
Clinical trials are essential in the development and evaluation of new therapies and eligibility criteria help to ensure the safety of patients participating in clinical trials. However, many cancer clinical trials for newer, targeted therapies use overly restrictive eligibility criteria that may not be scientifically justified and thus unnecessarily limit the diversity of participants. This can lead to a lack of representation of the real-world patient populations that will eventually use the drugs, limit the generalizability of trial results, slow enrollment, and perpetuate health disparities. Appropriate and scientifically informed broadening of eligibility criteria is essential to ensure data from cancer clinical trials are inclusive of patients with varying characteristics, such as different ages, comorbidities, and previous treatment histories. Inclusive clinical trials inform a more comprehensive understanding of treatment effectiveness and safety across representative patient populations and lead to more efficient advances in research that support earlier patient access to life-saving therapies.
Eligibility criteria are essential for ensuring the safety of clinical trial participants, but when they are overly restrictive, they can slow trial accrual and disproportionately exclude certain patient populations, contributing to disparities in access and outcomes. Broadening eligibility criteria helps to reduce barriers and increase access to clinical trials so more patients can benefit from innovative treatments.
Friends convenes patients, researchers, regulators, and industry stakeholders to reevaluate and develop recommendations for broadening eligibility criteria to support more inclusive and impactful cancer clinical trials. These collaborations led to the development of regulatory guidance and supported changes in the approach to defining eligible patient populations.
ASCO and Friends established a partnership to develop strategies to overcome overly-restrictive eligibility criteria in cancer clinical trials. Working groups focused on opportunities to broaden eligibilty criteria for the following areas.
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The partnership led to a series of manuscripts including recommendations for broadening eligibility criteria. ASCO & Friends submitted joint recommendations to the FDA to support development of guidance on cancer clinical trial eligibility in four areas.
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FDA finalized four guidance documents that incorporated concepts proposed in ASCO-Friends’ recommended guidance language.
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Brain Metastases
In 2017, an ASCO-Friends working group developed recommendations to support more inclusive enrollment of patients with treated/stable or active brain metastases, or leptomeningeal disease.
HIV/AIDS
In 2017, an ASCO-Friends working group developed recommendations to support more inclusive enrollment of patients with HIV/AIDS.
Minimum Age for Enrollment
In 2017, an ASCO-Friends working group developed recommendations for safe inclusion of children in early-phase investigational cancer drug trials.
Organ Dysfunction
In 2017, an ASCO-Friends working group developed recommendations to expand cancer clinical trial eligibility criteria to be more inclusive of patients with renal, hepatic, or cardiac dysfunction, prior/concurrent malignancies, and other comorbidities.
Washout Periods
In 2021, an ASCO-Friends working group developed recommendations for developing scientifically informed eligibility criteria around washout periods and concomitant medications.
Prior Therapies
In 2021, an ASCO-Friends working group developed recommendations for how to appropriately consider prior therapies when defining cancer clinical trial eligibility criteria.
Performance Status
In 2021, an ASCO-Friends working group developed recommendations to inform appropriately broadened eligibility criteria based on performance status.
Lab Tests
In 2021, an ASCO-Friends working group developed recommendations to optimize the use of laboratory tests when considering eligibility criteria.
Recommended Guidance Language
The recommendations developed through the 2017 ASCO-Friends working groups were compiled and submitted to FDA as recommended draft guidance language. These recommendations aimed to inform a series of guidance documents on cancer clinical trial eligibility criteria:
Cancer Clinical Trial Eligibility Criteria: Patients with Organ Dysfunction or Prior or Concurrent Malignancies
In 2020, FDA finalized guidance on “Cancer Clinical Trial Eligibility Criteria: Patients with Organ Dysfunction or Prior or Concurrent Malignancies.” The guidance includes several recommendations from the ASCO-Friends working group.
Cancer Clinical Trial Eligibility Criteria: Patients with HIV, Hepatitis B Virus, or Hepatitis C Virus Infections
In 2020, FDA finalized guidance on “Cancer Clinical Trial Eligibility Criteria: Patients with HIV, Hepatitis B Virus, or Hepatitis C Virus Infections.” The guidance includes several recommendations from the ASCO-Friends working group.
Cancer Clinical Trial Eligibility Criteria: Minimum Age Considerations for Inclusion of Pediatric Patients
In 2020, FDA finalized guidance on “Cancer Clinical Trial Eligibility Criteria: Minimum Age Considerations for Inclusion of Pediatric Patients.” The guidance includes several recommendations from the ASCO-Friends working group.
Cancer Clinical Trial Eligibility Criteria: Brain Metastases
In 2020, FDA finalized guidance on “Cancer Clinical Trial Eligibility Criteria: Brain Metastases.” The guidance includes several recommendations from the ASCO-Friends working group.
Project Outcomes
- November 2018: Taking recommendations from ASCO and Friends’ work, the National Cancer Institute (NCI) revised its clinical trial protocol template to include more expansive eligibility criteria for patients with pre-existing conditions in the following areas: brain metastases, HIV/AIDS, chronic hepatitis B, history of hepatitis C, organ dysfunction (specifically related to liver, kidney, and heart dysfunction), and prior and concurrent malignancies. The protocol template also removed barriers to clinical trial participation for patients under the age of 18.
- November 2020: FDA finalized four guidance documents on cancer clinical trial eligibility criteria: Patients with HIV, Hepatitis B Virus, or Hepatitis C Virus Infections, Brain Metastases, Patients with Organ Dysfunction or Prior or Concurrent Malignancies, and Minimum Age Considerations for Inclusion of Pediatric Patients.
- May 2021: An analysis of the impact of the 2017 ASCO-Friends recommendations published in Clinical Cancer Research showed that broadened eligibility criteria have the potential to expand the eligible patient population and include trial participants who are more representative of real-world practice.
- June 2021: On June 22nd, 2021, Friends and ASCO released a joint position statement encouraging Inclusion of Individuals with Cancer on COVID-19 Vaccine Trials.
- August 2021: Friends and ASCO submitted a joint public comment responding to FDA’s draft guidance on Cancer Clinical Trial Eligibility Criteria: Approach to Available Therapy in Non-Curative Settings.
- July 2022: FDA finalized guidance on Cancer Clinical Trial Eligibility Criteria: Approach to Available Therapy in Non-Curative Settings.
- September 2022: The NCI published a paper, “Implementing Modernized Eligibility Criteria in US National Cancer Institute Clinical Trials,” evaluating the implementation and uptake of the 2018 revised protocol template which included more expansive eligibility criteria based on ASCO-Friends 2017 recommendations.
