Trials & Tribulations: Removing Barriers to Participation in Clinical Trials to Advance Innovation

Health Highlights

Editor’s Note: In a new report commissioned by the Leukemia & Lymphoma Society (LLS), Manatt Health examines the barriers that may prevent patients from accessing clinical trials despite meeting clinical eligibility criteria and outlines strategies to ensure that eligible patients are able to seamlessly enroll and participate in clinical trials. This report, summarized below, describes the complex dynamics of clinical trials and proposes strategies to promote trial access for blood cancer patients. These findings and proposals are informed by interviews with providers that offer cancer clinical trials; payers that offer commercial, Medicare Advantage and Medicaid managed care plans in different states; and LLS’ conversations with blood cancer patients about their experiences seeking access to clinical trials.

Click here to download a free copy of the full report.

Clinical Trials for Cancer Patients Save Lives

Through clinical trials, eligible patients can receive the latest cutting-edge treatments, which may not yet be available nationwide.1 In addition to the potential benefits for trial participants themselves, promoting robust access to clinical trials accelerates the research on potential cures (by accelerating trial recruitment) and helps ensure that new treatments are sufficiently tested in sufficiently diverse patient populations.

Federal Law Requires Most Payers to Provide Coverage for Certain Services Associated With Clinical Trials

To help promote access to clinical trials, federal law requires all major payers—Medicare, Medicaid and commercial coverage (employer-sponsored and Marketplace plans)—to cover “routine patient costs” associated with participation in qualifying clinical trials, including services that are consistent with the standard of care and would normally be covered outside a trial. Trial sponsors cover the investigational drug or other product being studied or trial-related monitoring if such services would not normally be covered. However, patients find that there are often costs outside of what payers and sponsors will cover, leaving the burden of those costs with the patient and their families.

Despite Federal Laws, Barriers to Participating in Clinical Trials Still Exist

Among cancer patients who are found eligible for a clinical trial but choose not to enroll, financial concerns are commonly cited as a barrier, such as a denial of coverage by their health insurance.2 Even when coverage is available, the need for prior authorizations and other coverage-related processes can delay the patient’s ability to begin receiving services under the trial and can also create administrative burdens for patients, providers and payers alike.

Four Key Findings

Manatt Health’s research revealed four key findings:

Finding #1. Payers and providers agree on the value of clinical trial participation for cancer patients in most cases.

Finding #2. Administrative processes to enroll and successfully complete clinical trials can be significantly streamlined through provider, payer and policymaker action, particularly with respect to:

  • Coverage analysis and out-of-pocket-cost determinations;
  • Prior authorization requirements by payer prior to and during the course of clinical trials; and
  • Single case agreement negotiation and renegotiation during the course of clinical trials.

Finding #3. Patients often must seek clinical trials out of network as their only option, which presents greater coverage and access challenges.

Finding #4. The Medicaid program presents special challenges for enrolling in and completing clinical trials out of network and out of state.

The report aligns each of these four findings to a series of strategies specific to providers, payers and policymakers that individually and collectively would significantly mitigate coverage-related access barriers to clinical trials for blood cancer patients.


Clinical trials are a potentially lifesaving option for many blood cancer patients, and they are also the path to developing new cancer treatments, yet access to trials continues to be a major challenge for many patients. Despite federal coverage guarantees for routine patient costs associated with qualifying clinical trials, too many patients continue to run up against coverage-related barriers, including coverage denials or delays associated with coverage processes like prior authorization and single case agreements. These barriers are particularly acute when, as is all too common, the right trial for a cancer patient is outside their plans’ provider network, and potentially outside their home state.

1 Wei Chua and Stephen J. Clarke. Clinical Trial Information as a Measure of Quality Cancer Care. Journal of Oncology Practice 2010 6:3, 170–171.

2 Joseph M Unger, Ph.D., Dawn L Hershman, M.D., Cathee Till, M.S., Lori M Minasian, M.D., Raymond U Osarogiagbon, M.D., Mark E Fleury, Ph.D., Riha Vaidya, Ph.D. “When Offered to Participate”: A Systematic Review and Meta-Analysis of Patient Agreement to Participate in Cancer Clinical TrialsJNCI: Journal of the National Cancer Institute, Volume 113, Issue 3, March 2021, Pages 244–257.



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