Implementing Scientifically and Ethically Sound Trials

An ethical trial is defined as one with a scientifically rigorous design that aligns with the patient’s best interest, helping to maximize the benefits of participation for all patients, according to Ms. Tull. To support ethics in research, widespread practice includes a thorough scientific, statistical, and safety review; a review of the potential service provided to the population and priority cancers by the study; and, when consensus is obtained, the expeditious opening of the study.

Ms. Tull also discussed the 2-step process most cancer centers have in place to accurately achieve this goal and increase trust in the research being planned: (1) a first-stage review by the disease team, and (2) a second-stage review by the Protocol Review and Monitoring Committee, which includes medical experts, pharmacists, nurses, and patient advocates. Overseeing the adoption and execution of new trials is an interactive team of committees, including the Protocol Review and Monitoring Committee, the Data and Safety Monitoring Committee, and the Institutional Review Board; all are working to ensure patients receive the best available and ethical care.

The final piece to ensuring ethical conduct in research, Ms. Tull noted, is remembering the mistakes of the past. These include the infamous Tuskegee Study of Untreated Syphilis, conducted between 1932 and 1972, in which researchers failed to obtain informed consent from trial participants, and treatment was not offered to participants, even though by 1943 penicillin was considered an effective treatment for the condition.¹

Improving Clinical Trial Participation

During her presentation, Ms. Tull cited a 2018 report from the American Cancer Society Cancer Action Network, which found that only approximately 8% of patients with cancer are enrolled in clinical trials.² One way to improve enrollment, she advised, is to create a unified communication/action plan that is centered around the Cancer Center’s academic mission of expanding research and clinical trials.

“The literature…notes that when physicians discuss clinical trials with their patients, between 50% and 75% of patients would consider it, and many would consent to a trial. The problem is, the data show that 20% of the time it’s presented as a choice,” said Ms. Tull. “We know the best time to approach patients with new information is when it pertains to their health situation…We also finally know that physicians are our primary conduit for patients to enter clinical trials, and their knowledge and endorsement are critical.”

Ms. Tull suggests that cancer centers should make it easy for patients to obtain information about clinical trials by ensuring the following conditions are met:

• The trial details are delivered by knowledgeable staff, in a comfortable setting, in the patient’s primary language, and include the availability of social and financial support;

• Pamphlets are available for patients to take home;

• Patients are shown video clips of survivors talking about their clinical trial experience;

• Patients understand the purpose of the study, its procedures, the risks and benefits, any complementary treatments and choices, and are made aware that participation is voluntary and can be withdrawn at any time; and

• Patients always receive a copy of the consent form, including potential treatment side effects, impact on reproductive health, and financial information.

It is estimated that 1 in 3 cancer survivors report financial hardship due to the cost of active treatment, noted Ms. Tull, and financial concerns continue into cancer survivorship. To alleviate some of this cost burden, she suggested that cancer centers consider the financial barriers to clinical trial access and develop plans to ease financial toxicity for patients, including integrating reimbursement into pharmaceutical trial contracts, a method accepted by the FDA.

“This is particularly important because while the Patient Protection and Affordable Care Act mandates [that] most health plans cover routine costs for patients participating in clinical trials, coverage for Medicaid patients is left to the individual states,” explained Ms. Tull. “We all know coverage varies from state to state, so I encourage you to explore your organization’s policy while embedding reimbursement when available through established vendors. The burden of initial payment can fall on patients in some methods, but we do view this as a significant step forward.”

Use of Technology to Increase Clinical Trial Access for Diverse Populations

In addition to facilitating drug discovery data interpretation, advances in technology are making it possible to incorporate real-time patient data and feedback to improve clinical trial efficiency and accessibility. Such advances provide a more patient-focused approach to research, according to Ms. Tull.

“Technology will increasingly address geographic and demographic barriers to clinical trial participation, making research more accessible to very diverse populations. We will, however, have to work to ensure that the human touch never leaves cancer research care. I think, too, it’s important to understand that the rise of decentralized clinical trials, where affiliate locations separate from the main academic medical center engage in early-phase clinical trials, is gaining more interest following significant decline in enrollment felt by phase I trialists during and following the [COVID-19] pandemic,” she said.

Ms. Tull ended her presentation by encouraging attendees to recognize the power they have to accelerate treatment discovery and innovation to help successfully conclude the cancer journey for patients more quickly. “We are greater than the sum of our parts,” she emphasized. “And if we work together to bring clinical trials into the spotlight, supporting each other as a team, our partnership will equal success. Enrollment in high-quality clinical trials makes the greatest impact [on patients’ lives], and for those of us who work in research, every day is spent making an impact in someone’s life. I ask everyone to please join me in that quest. Find all of the ways your cancer center can expose patients to research and give them the choice. It’s a choice they deserve to make.”