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. 

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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 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. Broadening 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 efficacy 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 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 FDA 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.

Read the manuscript

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.

Read the guidance

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.

Read the guidance

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.

Read the guidance

HIV/AIDS

In 2017, an ASCO-Friends working group developed recommendations to support more inclusive enrollment of patients with HIV/AIDS.

Read the manuscript

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.​

Read the manuscript

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.​

Read the manuscript

Washout Periods

In 2021, an ASCO-Friends working group developed recommendations for developing scientifically informed eligibility criteria around washout periods and concomitant medications.​

Read the manuscript

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.​

Read the manuscript

Performance Status

In 2021, an ASCO-Friends working group developed recommendations to inform appropriately broadened eligibility criteria based on performance status.​

Read the manuscript

Lab Tests

In 2021, an ASCO-Friends working group developed recommendations to optimize the use of laboratory tests when considering eligibility criteria.​

Read the manuscript

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.​

Read the guidance

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.​

Read the guidance

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.

Read the guidance

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.

Read the guidance

Project Outcomes

2024

2022

2021

2020

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 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. 

2017

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.
 

Additional Resources