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 medical progress. Friends of Cancer Research (Friends) advocates for broader and more inclusive eligibility criteria, so that more people can participate in trials, to enhance the generalizability of trial results, reduce health disparities, improve trial efficiencies, and ultimately improve health outcomes for patients with cancer.
Clinical trials are essential to 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 use overly restrictive eligibility criteria that may not be scientifically justified and thus unnecessarily limit the diversity of participants. This can result in underrepresentation of real-world patient populations that will eventually use the drugs, limit the generalizability of trial results, slow participant enrollment, and perpetuate health disparities. Broadening eligibility criteria is essential to ensure that cancer clinical trial data reflect a diverse patient population, encompassing a broad range of ages, comorbidities, and previous treatment histories. Inclusive clinical trials provide a more comprehensive understanding of treatment efficacy and safety across diverse patient populations, enabling faster research progress and 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 hinder patient enrollment and disproportionately exclude certain patient populations, reinforcing disparities in access and outcomes. Broadening eligibility criteria helps to reduce barriers and expand access to clinical trials, allowing more patients to benefit from innovative treatments.
Friends worked with the American Society of Clinical Oncology (ASCO) to convene patients, researchers, regulators, and industry stakeholders to reevaluate and develop recommendations for broadening eligibility criteria that supports more inclusive and impactful cancer clinical trials. These collaborations led to the development of the U.S. Food and Drug Administration (FDA) guidance documents 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 eligibility criteria for the following areas.
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This partnership led to a series of manuscripts including recommendations for broadening eligibility criteria. ASCO and Friends submitted joint recommendations to FDA to support the 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.
Prior Therapies
We look forward to future guidance on this topic.
Laboratory Values
In 2024, FDA released draft guidance on “Cancer Clinical Trial Eligibility Criteria: Laboratory Values.” The guidance includes several recommendations from the ASCO-Friends working group.
Performance Status
In 2024, FDA released draft guidance on “Cancer Clinical Trial Eligibility Criteria: Performance Status.” The guidance includes several recommendations from the ASCO-Friends working group.
Washout Periods and Concomitant Medications
In 2024, FDA released draft guidance on “Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications.” The guidance includes several recommendations from the ASCO-Friends working group.
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:
Recommended Guidance Language
The recommendations developed through the 2021 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
2024
- FDA released three draft guidance documents on cancer clinical trial eligibility criteria: washout periods, performance status, and laboratory values.
2022
- The National Cancer Institute (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.
- FDA finalized guidance on Cancer Clinical Trial Eligibility Criteria: Approach to Available Therapy in Non-Curative Settings.
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.
- Friends and ASCO released a joint position statement encouraging Inclusion of Individuals with Cancer on COVID-19 Vaccine Trials.
- The working groups published a series of manuscripts in Clinical Cancer Research highlighting findings that encouraged updating eligibility criteria for washout periods, prior therapies, performance status, and lab tests.
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.
2019
- ASCO and Friends established new working groups to evaluate additional opportunities to modernize commonly used eligibility criteria in oncology clinical trials.
2018
- ASCO and Friends wrote a letter to FDA providing the recommendations outlined in the published manuscripts that included draft language for new guidance documents.
- Taking recommendations from ASCO and Friends’ work, the 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.
2017
- The working groups published a series of manuscripts in the Journal of Clinical Oncology highlighting findings that encouraged updating eligibility criteria for patients with brain metastases, HIV/ AIDs, and organ dysfunction, as well as setting minimum age for enrollment.
2016
- ASCO and Friends established working groups to identify opportunities to modernize eligibility criteria in oncology clinical trials and propose recommendations to make clinical trials more representative.