Insufficient recruitment has been found to be the leading cause of early termination of clinical trials. Improving support for primary care provider (PCP) referral of patients to clinical trials could provide a boost to poor clinical trial recruitment.
Since 50% of patient visits occur in primary care settings, it makes sense to implement recruitment strategies through PCPs. PCPs frequently have an ongoing relationship with their patients and it is well known that relationships and trust play a critical role in enrolling patients in clinical trials. Providing the necesary technological and operational tools to PCPs so they include more frequent referral of patients to clinical trials will significantly improve recruitment efficiency.
While many PCPs understand and support the intrinsic value of clinical trials, there are concerns regarding protecting patient well-bieng, perceived loss of control, and the workflow in the clinic. PCPs also need access to information to quickly assess the burden at both patient and provider levels.
Implementing clinical trial referral system in primary care is not only technically challenging, but also presents challenges at the person and organization levels. It involves considering workflow strategies and facilitators relevant to designing a technology-supported primary care clinical trial referral platform.
The US government’s passage of the 2009 HITECH Act has resulted in increased adoption of electronic health records (EHRs) and has made possible more automated processes for identifying potential trial participants.
Subsequently, on December 13, 2016, the 21st Century Cures Act (also referred to as the “Cures Act”) was signed into law with the intent to “accelerate the discovery, development, and delivery of 21st century cures”. The Act defined electronic health record (EHR) interoperability, addressed health information technology certification requirements, and prohibited information blocking. As of 2019, about three-quarters of office-based physicians (72%) and nearly all non-federal acute care hospitals (96%) had adopted a certified EHR.
Any technology-supported primary care clinical trial referral platform must plug into a PCP’s EHR and be able to (1) prefilter eligible trial participants, (2) ascertain patient interest in study participation through patient engagement, (3) request provider referral of specific patients, and (4) efficiently collect and share data. The technical design of these interventions must ensure that primary care referral processes are embedded into the provider’s workflow and are as non-intrusive as possible. The Primary care clinical trial referral platform affects many actors in the clinical care setting including patients, nurses, physicians, clinical coordinators, and investigators. Results of such platforms include improved efficiency achieved by reducing man hours per trial participant or by increasing the number of participants referred.