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Study: Clinical trial eligibility excludes more Black than white patients

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Contents

At a glance Questions for your doctor
Study findings Clinical trials
Strengths and limitations Related resources
What does this mean for me?  

 

STUDY AT A GLANCE


What is this study about?

This study is about how pancreatic cancer clinical trials are designed and how limitations on who is allowed to enroll may impact Black people, reducing the number who have access to these trials.

 

Why is this study important?

When researchers design clinical trials, they specify who will or will not be allowed to enroll in the study. The list of features that someone must have (or must not have) to participate in a clinical trial is known as “eligibility criteria.” For example, eligibility criteria might include having a certain type of cancer or having had a particular cancer treatment (or not).

Eligibility criteria are designed to ensure that a study can accurately answer questions about medical care. For instance, in a study looking at whether a drug benefits people with pancreatic cancer, it is important that participants have pancreatic cancer. Other criteria reflect how ill a person is or whether they are currently in treatment. Some conditions predict difficulty with the treatment proposed by the clinical trial, such as whether kidney function is normal, if someone is pregnant or has another disease (such as congestive heart failure) that may impact their ability to tolerate the clinical trial treatments.

When eligibility criteria are too restrictive, many people who wish to participate may not be able to. Some eligibility criteria are carried over from older trials. This can lead to unequal access to clinical trials for people from underserved populations, including people of color. Without adequate diversity among participants, the trial will not be able to answer how the results will impact these underrepresented groups. Revising eligibility criteria to allow more diverse participation means that the results of the research are more likely to apply to a broad group of people.

This study asked what would happen if eligibility criteria were relaxed to allow more participants to qualify. The results suggest that revising standard eligibility criteria would make clinical trials more inclusive. The proposed revised criteria are in line with recommendations made by several expert groups, including the Food and Drug Administration (), American Society of Clinical Oncology (ASCO) and Friends of Cancer Research.

 

Study findings

This study looked at the medical records of people diagnosed with pancreatic cancer at Virginia Commonwealth University, Massey Cancer Center. The researchers found that among people treated at Virginia Commonwealth University Health from 2010 to 2019, Black people were less likely to be eligible for a pancreatic cancer clinical trial compared to white people.

  • 42% of Black people were ineligible for clinical trials compared to 33% of white people based on the trial's eligibility criteria.
  • Factors that led to differences in eligibility included:
    • Low albumin levels (Albumin is a protein that helps keep fluid in blood vessels.)
    • HIV infection (HIV is the virus that causes AIDS.)
    • Hepatitis C infection

Sometimes when researchers design studies, they choose eligibility criteria based on what has been used in the past. In this study, these “traditional” criteria led to greater barriers to enrollment for Black people compared to white people.

Researchers looked at who would have been eligible if revised criteria were used with the same patients. The revised criteria included removing conditions that could be medically managed, such as Hepatitis C and HIV infection, diabetes and previous cancers.  With these revised criteria, they showed that Black people would have been equally likely as white people to be eligible for clinical trials.

  • 27% of Black people were ineligible compared to 25% of white people.

Changing eligibility criteria is one way to increase the diversity of people who enroll in pancreatic clinical trials. Results would then better reflect the current pancreatic cancer patient population. The common eligibility criteria barriers outlined here for pancreatic cancer clinical trials are often used in other cancer trials. The results of this study are likely to have implications for other cancer types.
 

Strengths and limitations

Strengths

  • Virginia Commonwealth University is in an area with a very diverse population. Black patients make up a large proportion of the patient population.

Limitations

  • This is a small, single-institution study and may or may not reflect other communities.
  • This is a study. These studies can be limited by missing or improperly recorded data.
  • This study covered a decade of patient records, during which changes may have occurred in treatment, insurance coverage, etc. Researchers studied Black and white people over this time, meaning that both groups of people should be equally affected by potential changes; however, these changes may have a differential impact due to racial bias.
  • The researchers’ proposed strategy of loosening eligibility criteria was not evaluated for medical appropriateness across the identified trials.

 

What does this mean for me?

This study suggests that access to clinical trials for pancreatic cancer may be unnecessarily restrictive and those restrictions can differentially impact Black versus white people. People with pancreatic cancer who wish to participate in research studies may be able to overcome some of these barriers.  For example, seeing a nutritionist may help them to increase low blood albumin levels.  If a clinical trial is not available to you, talk to your doctor to see if the barrier that keeps you from participating can be overcome. 

 

References

Riner N, Girma S, Vudatha V, et al. Eligibility criteria perpetuate disparities in enrollment and participation of Black patients in pancreatic cancer clinical trials. Journal of Clinical Oncology; 2022: JCO-21. https://ascopubs.org/doi/full/10.1200/JCO.21.02492

 

Disclosure: FORCE receives funding from industry sponsors, including companies that manufacture cancer drugs, tests and devices. All XRAYS articles are written independently of any sponsor and are reviewed by members of our Scientific Advisory Board prior to publication to assure scientific integrity.

 

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posted 8/23/22

This article is relevant for:

People with pancreatic cancer who are interested in participating in a clinical trial

This article is also relevant for:

People with pancreatic cancer

People with a family history of cancer

People with a genetic mutation linked to cancer risk

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IN-DEPTH REVIEW OF RESEARCH


Study background

Numerous studies have identified a disparity in cancer outcomes between Black and white people.  One reason for this may be due to differences in access to clinical trials, which offer newer therapies or combinations of therapies. Eligibility criteria are strict barriers to enrolling in these trials. Traditional criteria may not always be medically guided and may promote inequitable access to clinical trials.

Results are less generalizable when the diversity of participants in a clinical trial is low. If results are similar between racial groups, doctors can be more confident in treatments. And if results differ, understanding those racial differences in treatment safety and effectiveness allows physicians to anticipate complications and tailor treatments more appropriately. This study suggests that revising the eligibility criteria to align with recommendations by the Food and Drug Administration (), ASCO and Friends of Cancer Research (Friends) in a medically sound way would improve equitable access to clinical trials.
 

Researchers of this study wanted to know

Do eligibility criteria contribute to racial disparities in accessing clinical trials? If so, would aligning eligibility criteria with recommendations by impact racial disparities in accessing clinical trials?
 

Populations looked at in this study

People aged 18 years or older who were treated for pancreatic ductal adenocarcinoma at Virginia Commonwealth University’s Massey Cancer Center from January 1, 2010 to December 31, 2019, were included in this study.
 

Study design

This was a cross-sectional study, meaning that it evaluated the medical records of people who had been diagnosed with pancreatic cancer over a specified period.

Patients were evaluated to see if they met the eligibility criteria for clinical trials that were enrolling during 2010-2017, as identified through clinicaltrials.gov.  A total of 676 people (42.5 percent Black and 51.6 percent white) were evaluated for eligibility for 86 available Phase II and Phase III clinical trials. 

This study looked at traditional eligibility criteria that could be determined by history, such as laboratory test results. Researchers looked at the number of people who were eligible for clinical trials out of all who presented for treatment, comparing the percentage of Black to white people who were found eligible.  Researchers then recompared eligibility by race, using revised criteria as recommended by guidelines released in 2020, ASCO and Friends guidelines. The proposed revisions to traditional eligibility criteria for pancreatic cancer clinical trials are outlined in the table below.

Traditional criteria Guidelines Proposed revised criteria
History of cancer within the past 3 years

Patients with prior cancer should be included if treatment was >2 years prior and no evidence of disease

Patients who currently have cancer should be eligible if stable and no targeted treatment
Remove if a patient is currently off therapy
HIV infection Patients should be eligible based on blood tests and have no history of AIDS Remove if well-controlled and antiviral medications have a low risk of drug interaction with trial treatment
HBV or HCV infection

HBV: Access eligibility for anti-HBV therapy and require starting therapy prior to enrollment

HCV: Eligible if antiviral treatment is ongoing or completed
Remove if well-controlled and antiviral medications have a low risk of drug interaction with trial treatment
Uncontrolled diabetes No specific guidance Remove. This can be well-controlled in a short time
Coronary stent within past 6 months No specific guidance Remove if asymptomatic and clearance is given from a cardiologist
Creatinine and creatinine clearance test results Assess creatinine clearance levels rather than serum creatinine Remove serum creatinine and use creatinine clearance levels, which better reflect kidney function

 

Study findings

This study examined the medical records of patients and found that Black people were less likely to be eligible for pancreatic cancer clinical trials compared to white people who were treated at the same institution during the same period.

  • 42.4% of Black people vs. 33.2% of white people were ineligible for clinical trials based on objective eligibility criteria.

Specific eligibility criteria that contributed to the differential access included:

  • Blood albumin levels (14.1% of Black people were ineligible vs. 7.9% of white people)
  • Infectious history
    • HIV (3.1% of Black people were ineligible vs. 0.3% of white people)
    • Hepatitis B (1.7% of Black people were ineligible vs 0% of white people)
    • Hepatitis C (9.1% of black people were ineligible vs. 3.4% of white people)
  • The researchers also looked at the following:
    • Uncontrolled diabetes mellitus (8.6% of Black people were ineligible vs 6.0% of white people)
    • Kidney function (5.7% of Black people were ineligible vs. 3.0% of white people)
    • Recent coronary stent (1.4% of Black people were ineligible vs. 0 white people)
    • Prior cancer (2.4% of Black people were ineligible vs. 2.6% of white people)
    • Prior cancer treatment (9.1% of Black people were ineligible vs. 14.0% of white people)

None of these factors met statistical significance.

When the researchers applied the revised criteria to the participants, the disparity in access was resolved. Using the revised criteria:

  • 26.8% Black vs. 24.8% white people (p =0.023) were ineligible for clinical trials.

Strengths and limitations

Strengths

  • Virginia Commonwealth University is in an area with a very diverse population.  Black patients make up a large proportion of the patient population.
  • The authors appropriately recognized that revising eligibility criteria is one factor in addressing racial differences in clinical trial participation. 

Limitations

  • This study was retrospective; it may be limited by missing or improperly recorded data.
  • This study covered a decade of patient records, during which time there may have been changes in documentation, coding or health management.  As researchers studied Black and white people during this same time, both groups should be equally affected by potential changes. However, these changes may have a differential impact due to racial bias.
  • This study was small and involved a single institution.
    • A larger, multi-institution study may evaluate differential access by other races and add depth to Black and white disparities to ensure comprehensive modification of eligibility criteria.
    • Because this was a small, study, the focus was necessarily narrow and cannot address all potential barriers to clinical trial eligibility. 
    • The authors specifically commented that their study does not address subjective criteria.
  • Additional barriers to accessing clinical trials in a real-world setting include:
    • Documented delays in diagnosing Black patients compared to white patients. Delays in diagnosing cancer can impact trial eligibility, as overall health may deteriorate the longer cancer is unidentified and untreated. Additionally, some clinical trials are restricted to earlier stages, which would need to be identified earlier. Barriers in diagnosing cancer may be due to racial bias of medical providers, socioeconomic or geographical barriers to accessing care that differentially impacts black versus white people and younger age at onset among black people. 
      • Relatively decreased wealth accumulation due to race and younger age of cancer onset in Black people can lead to a different ability to access insurance, sustain time off from work and/or manage other responsibilities such as childcare.  This may also impact trial eligibility, as the frequency and demands of required visits can be more challenging for those with less financial or temporal resources.
      • Geographical availability of clinical trials in areas with high Black populations. Novel therapies may require specific tools or specialists, which may not be funded in areas with higher Black populations.
  • The proposed strategy of loosening eligibility criteria was not evaluated for medical appropriateness across the identified trials.
     

Conclusions

Although this study was limited to pancreatic cancer, revising eligibility criteria is likely applicable to other cancer types. This study identified eligibility criteria for pancreatic cancer clinical trials as a potential cause of decreased access to clinical trials for Black people compared to white people. Decreased access means that Black people are less likely to benefit from newer therapies.  Also, studying newer therapies in a less diverse group of people means that the safety and effectiveness of these therapies may not be well understood for diverse recipients of these therapies outside the context of a clinical trial.  This, in turn, perpetuates racial disparities in cancer treatment outcomes.

The authors of the study encourage clinical trial designers and regulators to make eligibility criteria less restrictive, if medically appropriate, which can make access to clinical trials more racially equitable.  They propose specific criteria changes and show that these changes promote equitable access to clinical trials using the same patient population.

Overall, this study identifies room for improvement and the need for further evaluation of clinical trial design in improving equitable access to clinical trials. It also encourages physicians and patient advocates to push for more medically justifiable eligibility criteria that do not perpetuate disparities in clinical trial participation.

Although this study was specific to pancreatic cancer, restrictive exclusion criteria have been identified as a concern for many types of cancer. Just how applicable this research is across cancer types is unclear, although there may be criteria among many trials that are unnecessarily restrictive for the question being asked.
 

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posted 8/23/22

Questions To Ask Your Doctor
Questions To Ask Your Doctor

  • Am I currently eligible for any clinical trials?
  • What can I do to increase my eligibility for clinical trials?

Open Clinical Trials
Open Clinical Trials

The following are studies enrolling people diagnosed with pancreatic cancer:

Other clinical trials for people with pancreatic cancer can be found here.

Updated: 08/23/2022

Peer Support
Peer Support

The following organizations offer peer support services for people with or at high risk for pancreatic cancer:

Updated: 08/23/2022

Who covered this study?

MEDPAGE TODAY

Eligibility criteria exclude more Blacks from pancreatic cancer trials This article rates 3.5 out of 5 stars

U.S. News & World Report

Black Patients Less Likely to Get Into Pancreatic Cancer Clinical Trials This article rates 3.0 out of 5 stars

How we rated the media

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