A paper published January 9, 2024 in the journal Cancer details three calls-to-action that the oncology research and clinical care communities should implement to expand access to clinical trials and improve inclusivity to enable more people with cancer to participate in clinical trials closer to home.
The paper, authored by members of an American Society of Clinical Oncology (ASCO) Task Force, illuminates the importance of enabling patients to receive trial related testing and care near their homes, rather than requiring patients to travel long distances to reach major research institutions.
During the height of the COVID-19 pandemic, the research community quickly adjusted and adopted new clinical trial accommodations for the safety of patients, effectively decentralizing clinical trials and bringing them closer to participants’ homes. These accommodations received support from the US Food and Drug Administration (FDA) and the National Cancer Institute (NCI). As the stressors from the pandemic have lessened, the Task Force identified instances of sponsors and institutions reverting to traditional research models and creating unnecessary roadblocks, thereby restricting patient access to novel treatment options.
Below is a brief overview of the three calls-to-action. Read the full paper, “A Call to Action to Advance Patient-Focused and Decentralized Clinical Trials,” to get complete details of the recommended strategies.
Action 1: Clarity with the FDA Statement of Investigator (Form 1572)
Form 1572 is intended to provide trial sponsors with information about investigator and site qualifications and inform the investigator of their responsibilities and commitment to follow pertinent federal regulations. The Task Force, however, identifies that overly cautious trial sponsors and contract research organizations (CROs) often use the form as a method to collect information about medical providers and ancillary facilities, causing unnecessary administrative burden for research sites, which snowballs leading to time toxicity and resource waste. These practices are commonly seen even for providers who deliver routine care or testing for research participants.
The Task Force additionally pointed out the need for clearer definitions, requirements, and expectations within the form’s language. Specifically looking at the phrase “direct and significant contribution to the data.” For example, a nurse may administer investigational treatment as part of the patient’s care, but with the current language in Form 1572, it’s not clear if that would be deemed a direct and significant contribution of data.
Action 2: Routine Acceptance of Local Laboratory and Imaging Facilities
The Task Force recommends that locally obtained laboratory values and radiographic imaging used for routine care should be used for trial safety and efficacy determinations. Patients enrolled in trials are frequently required to travel to complete safety and efficacy assessments at larger research centers, even though safety and efficacy assessments are typically performed in local practices and facilities. COVID-19 showed these methods are feasible and help to minimize participant burden. The Task Force states that eliminating the requirement to add laboratories to Form 1572 will enable participants to visit any Clinical Laboratory Improvement Amendments-certified lab to obtain routine clinical testing during the trial and reduce common participant barriers such as travel while also minimizing risk to sponsors and sites. Another strategy identified is improved digital sharing of protocol-required results through electronic health records between research institutions and local providers, laboratories, and imaging facilities.
Action 3: Foster Partnerships to Increase Patient and Local Clinical Access to Trials
The final strategies fall within the larger category of improving partnerships with patients and local clinicians. While there are successful partnerships between non-academic sites and academic centers and research networks, many community oncology practices and programs face challenges with access to clinical trials and/or lack the necessary resources to enroll patients in clinical trials. The Task Force identifies the need for financial investment to make these partnerships possible, through such concepts as innovative and incentivization reimbursement models, trial sponsors and CROs contributions, and national healthcare policy to prioritize funding community-academic partnerships. The Task Force also recommends leveraging technology to facilitate partnerships, minimize risks, and streamline processes.
All stakeholders stand to benefit from these collaborations, including offsetting costs, preserving the shrinking workforce, accelerated enrollment and study completion, and increased participation among more diverse patients and underserved communities.
Read the full paper for complete details on all three calls-to-action, and to see what strategies may work for your site today.
