Dr. Reem Yunis serves as the Director of Clinical Affairs at Medable. She holds a PhD in Genetics from the Hebrew University of Jerusalem. Dr. Yunis has multidisciplinary research experience in the mechanism of diseases including cancer. She has expertise in clinical research, operations, and regulatory.
Dr. Oakley-Girvan received her Ph.D. from the Stanford University School of Medicine and her M.P.H. from Tulane University School of Public.
Save the Date!
The future is here.
For all its terrible consequences on humanity, COVID-19 has spurred a notoriously risk-averse life sciences industry to embrace a new clinical trial model along with the remote technologies that patients and clinicians have wanted for years. Today, researchers are suddenly conducting clinical outcome assessments (COAs) remotely through applications like Medable TeleCOA. Remote eCOA solutions and other technologies that allow a decentralized clinical trial model offer the potential to upend the current research paradigm.
According to a new PPD survey, nearly half (45%) of respondents cited eCOAs as having the most positive on trial performance. Also, remote eConsent (42%), televisits (41%), home healthcare (37%), direct-to- and direct-from-patient services (35%).
Of central importance is the potential for decentralized clinical trial (DCT) models and supporting solutions to enable a level of patient care and trial access that has never been possible before. Their adoption could close the clinical trial inequality and improve diversity. Telemedicine enabled eCOA solutions can open trial participation by enabling recruitment of patients who are no longer limited by proximity to the clinical site, an obstacle for recruiting minorities and people in lower socioeconomic environments.
Ironically, it’s a simple idea – by conducting patient assessments remotely, fewer in-person visits are needed. As a result, more rural patients, busy single-parent patients, and patients with less access to health care may be more willing to participate in trials that allow for more remote interactions with site teams.
TeleCOA can also eliminate healthcare burdens such as the stress of taking time off from work and lost wages, and long commutes to and from the site. A Harvard School of Medicine study, in fact, showed that an in-person doctor visit in the U.S. takes about 121 minutes – and only 20 minutes of that time is spent face-to-face with a doctor. This amounts to 1.1 billion wasted hours each year and $25 billion in lost productivity from employed adults!
Utilizing TeleCOA in clinical trials also has the potential to better capture the natural history of disease, and enhance recruitment and retention of patients with rare diseases by offering remote access to specialized medical care. For instance, a recent study was designed to test the utilization of Televisits and TeleCOA for patients with narcolepsy, a rare underdiagnosed disorder that requires a multidisciplinary approach for its diagnosis, monitoring, and management, allowing more patients to participate in the study. Remotely managing patients at their home eliminates the need to travel to seek consultation at the scarce number of sleep centers and allows a longer monitoring period compared to the limited one conducted at sleep center visits. It also provided a better understanding of the disorder within the patients’ natural environments for collection of richer real-world data.
TeleCOA provides an extraordinary opportunity, too, to capture longitudinal data that allows for more precise and rapid assessment to changes in health. With this data, trial teams know more about how patients are doing in real time because visits are less likely to be missed (due to travel or work issues) and assessments can be done with greater frequency. More frequent assessments also provide better insight into interim outcomes and provide patients with that gold level of care.
Take, for example, cancer patients in the COVID-19 pandemic: concerned about their safety, many avoided office visits, impacting their performance assessments and, subsequently, their treatment plans. When clinics adopted televisit models, clinicians were able to conduct TeleCOA by remotely observing their patients and asking them to complete specific physical activities live and on-screen, allowing in-home clinical assessment of patient’s physical capability and better informing clinical decisions and treatment plans.
Having their clinic visit from the comfort of their home, patients are likely to be more relaxed and, as behavioral health literature suggests, more accurate data may be captured for some measures versus in-office visits when many patients experience high blood pressure (BP) due to the anxiety from the “white-coat” effect. White coat hypertension increases the risk for cardiovascular diseases and overall mortality as was found in a metanalysis by Cohen et al (2019).
Monitoring and recording BP at home between clinic visits is also becoming an integral part of a patient’s care management plan for many chronic diseases, and it must be correctly captured. In another example of better data capture and care, if there is a concern that an Alzheimer's drug may increase or decrease BP, a patient could easily be provided with a remote BP cuff and participate in more frequent assessments than would normally be done through office visits. In a TeleCOA visit, visual assessment of the BP measurement process could be observed and if the patient is improperly conducting the measurement such as incorrectly placing the BP cuff, standing up, or crossing their legs, this could be instantly addressed and fixed. Moreover, TeleCOAs might drive early insight into previously unexpected symptoms such as dehydration prompting doctors to offer rapid advice – improving patient care and preventing patients from dropping out of a trial unnecessarily.
Additionally, it is commonly understood that patients may provide a rosier picture of their health when meeting doctors in person and are reluctant to provide more sensitive data. TeleCOAs could reduce these effects and instead allow patients to feel more comfortable providing a more realistic picture of health concerns. For example, if early data suggests an oral chemotherapy may cause sexual dysfunction, patients might provide a true accounting of this information over a televisit but not in person. Regular longitudinal critical data could also reveal these early health concerns during a time period in which they can be easily addressed rather than when the situation is either acute or entrenched and then requires significant intervention or causes the patient to drop out of the trial.
It is impossible to know what the future still holds, but one thing is for certain – remote clinical trial technologies like TeleCOA have permanently changed how research is conducted. Now, regular clinical outcome assessments can be easily done from the comfort of the patient's home, which improves the quality of data captured to expand trial participation and indications. It enables a wholesale improvement on the patient experience, real potential for increased diversity in enrollment, increased trial efficiency, fewer trial dropouts, and ultimately shorter trial timelines. It’s a win, win, win, win.