Clinical trials are moving toward a decentralized approach post-COVID-19. The opinion in the industry is that it is inevitable that many components of clinical trials, starting with patient recruitment and completion of a trial, will occur outside of a traditional site. There is momentum to involve traditional clinical care settings like hospitals and outpatient clinics; employed physicians or private practitioners can provide a very useful role in clinical trials. There are several areas needing to be addressed in how to make this a fruitful, fulfilling engagement for patients.
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 clinical trial referral platform must plug into a Physician’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 and specialist referral processes are embedded into the provider’s workflow and are as non-intrusive as possible. The Primary care and specialist clinical trial referral platform affect 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.
The first question that is raised by Physicians is, “What’s in it for me”? Physician practices face ongoing dissatisfaction points and burnouts with health insurance and regulatory requirement layers, which are burdensome in some instances. Physicians are considering different approaches to see what is out there other than direct patient care, which could be administrative roles or perhaps off-the-track fields like hospice care, clinical trials, or medical directorships in Accountable Care Organizations (ACOs) or payor provider networks, depending on the interest of Individual physicians.
Physicians have a keen interest in getting involved in any innovative ideas in the healthcare ecosystem. They want appreciation for their clinical efforts, and clinical trials may offer a unique angle. Physicians also have a direct relationship with patients who may want to participate in clinical trials for reasons including free care, scientific innovations, and therapies not available in the mainstream or philanthropic or financial incentives. Interoperable EHR standards and regulatory requirements are opening up doors for patient recruitment and completion of clinical trials. Clinical trials industry segments like CROs and research sites are now open to taking the approach of involving patients via their established physicians who may have an interest in patient referrals, screening, or even participating as Investigators. Physicians expect transparency and accountability from a somewhat unfamiliar landscape of clinical trials, including reimbursement structure and value of clinical care gratification. Employed physicians are looking for incentive structures like Relative Value Units (RVUs) for patient screening or even to be part of a clinical trial as an investigator.
Health Wizz, is an innovative platform enabling Physicians to facilitate database search and identify patients to suit clinical trials that might fit their needs efficiently.