Digital Health Corner Editor: Parisa Vatanka, PharmD, CTTS
The pandemic has highlighted a need for improved communication channels that help patients participate in clinical trials. Rather than ask patients to take time off of work and make long trips as a requirement of participation or just to find out they are not eligible to participate, why not expand an existing communication channel?
The Avoca Group notes that “Decentralized clinical trials (DCTs) offer a more patient-centric approach, reflecting a transformational philosophy for the conduct of clinical trials in which fewer clinic visits are required and patient and caregiver burden is reduced.”1 From an implementation standpoint, clinical trials can continue to follow the existing model that centers on visits to the clinic for all interactions or they can adapt. It is increasingly apparent that the standard approach limits broad participation and sets-up multiple barriers and burdens for patients and their families. Instead, we can consider innovation centered on the patient. How do we conduct remote assessments, how do we bring services to patients or to places they frequently visit in daily life? The determination of what can be done remotely will be dependent upon the therapeutic area, what is involved in the trial, and what communication channels and technology solutions are available.
Technology solutions such as telehealth, connected devices, eConsent, and electronic clinical outcome assessments (eCOAs) have evolved to support the DCT model. Mobile and digital technologies replace written diaries with electronic diaries and collect data from wearable sensor devices. Many reliable devices are now available to remotely measure specific vitals such as heart rate variability, blood pressure, temperature, oxygen level, and more. But, despite the value of a more decentralized approach, for complex assessment needs that fall outside of current technology capabilities, clinical trials still experience challenges. How can we solve this problem?
Even during the pandemic, many of us have continued to regularly visit the pharmacy – it is often right next to or in the grocery store making it very convenient. In rural locations, the pharmacist knows almost everyone, and the pharmacy may well be closer than the doctor’s office. It can be a hub of social interaction (even six feet apart and masked) and many now resemble one-stop shops with groceries and essential hardware items like light bulbs. In other words, convenience, and products we use on a regular basis are accessible, why not expand this communication channel to make clinical trials more accessible?
Across the United States, COVID-19 has prompted new service offerings by pharmacists and pharmacy technicians including COVID-19 testing and vaccinations. For clinical trial screenings or on trial assessments that cannot be performed remotely or by a telehealth visit, reimbursement codes could be added to allow pharmacists to conduct these in-person. It would open up more treatment opportunities for patients regardless of physical location and could begin to chip away at disparities in clinical trial participation. Of course, no one solution will erase all the barriers, but given that pharmacists are already embedded in our communities, this would be a win for everyone.
Dr. Oakley-Girvan received her Ph.D. from Stanford University School of Medicine and her M.P.H. from Tulane University School of Public Health and Tropical Medicine. She is a member of the Stanford Cancer Institute, the Canary Center at Stanford for Cancer Early Detection, and is SVP of Research and Strategy at Medable Inc. Key accomplishments include clinical trials and research work in mobile and digital technology, particularly in oncology, device utilization, and behavioral health interventions. She has documented disparities in breast and prostate cancer in addition to investigating biomarkers – both digital and lab bench based. A hallmark of her work is combining multi-disciplinary studies and technology with business partnerships to more rapidly advance a direct-to-patient approach for impactful work that improves population and individual health.