Addressing Challenges in Cancer Trials Accrual: A Look in the Mirror
The problem
Cancer research professionals know that participation in cancer treatment clinical trials is a key measure for delivery of quality cancer care. For example, “the best management for any patient with cancer is in a clinical trial,” according to the National Comprehensive Cancer Networkguidelines. And, according to a recent Institute of Medicine (IOM) committee report, all participating physicians should “strive to make participation in clinical trials a key component of clinical practice and to achieve…high accrual rates of 10 percent or more.”(1) Yet-- adult trial participation in the U.S. remains under 3%,(2,3,4) with even lower participation rates among ethnic and racial minorities and people over 65.(5,6,7) Only between 9 and 20 percent of cancer patients are informed about the option of participating in a cancer treatment trial.(8,9,10,11,12) Even at major cancer centers, oncologists may not approach all eligible patients about participation(13,14) and patients from minority groups or who are 65 or older may be less likely to be approached, regardless of eligibility.(15,16,17,18,19) Because cancer treating institutions are credentialed by the access they provide to clinical trials, it is critical to identify practical, evidence-based approaches to maximize the efficiency of recruitment, accrual, and retention efforts.
Oncology professionals struggle with accrual for many reasons, well documented in the literature.(20) Often overlooked are barriers related to ineffective operational procedures(21,22) poor community relationships, and ineffective physician-patient communication.(23,24) The Education Network to Advance Cancer Clinical Trials (ENACCT), a nonprofit clinical trials advocacy organization, has conducted research, training and consulting work with over 30 cancer centers and community oncology practices. Over the past seven years, ENACCT has noted a number of persistent challenges to accrual, often well within the control of the local institution or oncology practice:
Challenges around procedures and policies
- A systemized process for trial selection is seldom employed, often relying on individual physician interest. This leads to poor patient/trial match, inconsistent organizational commitment to a study, and low accrual rates.(25)
- About 30% of accrual sites (substantially more based on ENACCT’s experience) have no systematic approach to screening patient charts for patient eligibility.(26)
- Very few institutions have outlined any requirements for its physicians to enroll patients into the institution’s open trials(27).
Challenges around clinician behavior and skills
- In most accrual sites, approximately 70% of patients are recruited by 30% of participating physicians and 33% of affiliated physicians do not accrue any patients(28)
- Due to poor screening systems, all eligible patients are not approached about participation
- The quality of the discussion around clinical trials as a treatment option is highly variable, with no best practices as to when and how the topic should be introduced in relation to standard of care.(29,30)
- Assessment of comprehension of the consent process is seldom implemented.
- Assumptions about treatment preferences (i.e., standard care)(31,32) are often made before discussions about cancer clinical trials are ever raised.
Getting down to solutions
How do the policies and procedures of your own institution or clinic ensure that each and every patient has meaningful access to clinical trials? In institutions/clinics who offer trials, we need to ensure that a) 100% of cancer patients are screened for clinical trial eligibility and b) 100% of eligible patients are approached about clinical trial participation. We must improve commitment to trials for all staff —from the front desk to the medical assistant to the accruing physician; and strengthen provider skills in better communication around cancer trials.(33,34,35) In those institutions who don’t offer trials, we must ensure education and referral is more than a brochure and a phone number in a new patient folder.
Developing realistic and practical procedures to ensure meaningful access can help institutions/clinics efficiently reach the 2015 minimum clinical trial accrual percentages outlined by the Commission on Cancer. Over the past few years, ENACCT has been working with community oncology practices and cancer centers to examine their policies and procedures and help them make changes for more efficient accrual, especially for minority populations, based on the broad goals and actions outlined in the table below.
We can all point to numerous barriers to accrual outside of our control, but by taking an honest look in the mirror, we can make impactful changes within our control to help maximize access to clinical trials for all of our patients.
REFERENCES CITED
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