by Raphael Yaakov
September 18, 2020
After 9 months of an unwavering level of cooperation among academic, industry and policy makers, and over three thousand COVID-19 trials, there are still no clear answers on how to curtail the virus.1 The studies underway have some obvious limitations, including lack of blinding or masking and small sample size, which renders the results less meaningful and applicable to the real-world. Moreover, earlier studies distorted public perceptions, therapeutic decision-making and investment in healthcare. Adding to the problem, there is a lack of due consideration for high standards and ethics. For a closer look at the ethical implications of SARS-CoV-2 research, see Dr. Carter’s recent blog.
There continues to be a great need to speed up innovation and bring effective therapies to patients sooner. The gap between scientific discovery and successful drug development can exceed 10 years. Site identification to site initiation alone can take up to 8 months.2 Furthermore, majority of the clinical studies often experience lengthy delays; 81% will reach delays up to 6 months.3 It is disconcerting that the clinical trial cycle is not getting any faster compared to findings 10 years ago.2 While mobile technology is becoming more pervasive in healthcare, it has not been leveraged to the full extent in the clinical research space.
It was not until recently that telehealth became mainstream. Despite garnering major attention, the use remains limited to clinical practice. Telehealth modalities coupled with connected devices, sensors, and wearables are paving the path for a new paradigm. Pragmatic, hybrid and fully decentralized trials (DCTs) offer a new, agile and more efficient way to conduct trials that incorporate real-world evidence. It can reduce administrative burden, lower costs, and accelerate study timeline without compromising the quality and integrity of the data.
Tech giants like Apple (Cupertino, CA) and Google (Mountain View, CA) have been preparing to encroach this space for years. Especially noteworthy is the Apple Heart Study (AHS) which evaluates use of photoplethysmography to intermittently measure blood flow activity and detect subtle changes that indicate an irregular heartbeat.4 The study included 419,297 self-enrolled patients from all 50 states. Detection of repeat irregular pulse within a 48-hour period triggered a notification, which prompted participants to contact the study doctor through the video consultation app. The positive predictive value (PPV) for the tachogram was 71% and the PPV for notification was 84%.4 While this study relied on patient-reported data, it is the largest study of its kind that spanned only 8 months.
Most recently, in collaboration with eKare Inc (Fairfax, VA), TissueTech (Miami, FL) launched a phase 3 diabetic foot ulcer study that utilize risk-based remote monitoring.5 eKare’s patient app enables wound images to be captured by a patient at home and measured automatically without the need for reference or calibration markers. The clinician can review the images and accept tracing in real-time. eKare’s telehealth platform is fully integrated with inSight, which allows patient records to be easily accessed at the time of teleconsultation.
These early studies represent a paradigm shift for how clinical research can be conducted beyond the public health emergency. DCTs can increase patient-centricity, improve resource management, minimize recruitment and retention barriers and accelerate the clinical trial cycle. Risk-based remote monitoring ensures high quality of clinical data and enhances patient safety. Moreover, when studies are performed in the real-world setting, the results are highly generalizable and actionable at a fraction of the cost and time needed for a traditional randomized clinical trial.
- NIH U.S. National Library of Medicine. https://clinicaltrials.gov/ct2/results?cond=COVID-19&term=&cntry=&state=&city=&dist=.
- Tufts Center for the Study of Drug Development (CSDD). First comprehensive clinical site initiation benchmark, developed by Tufts CSDD, finds study startup is lengthy and inefficient. https://csdd.tufts.edu/csddnews/category/Press+Release. 2018.
- Aldrich S. Clinical trial outsourcing report. https://www.contractpharma.com/issues/2012-03/view_features/clinical-trial-outsourcing-report.2012.
- Apple. Stanford Medicine announces results of unprecedented Apple Heart Study. https://www.apple.com/newsroom/2019/03/stanford-medicine-announces-results-of-unprecedented-apple-heart-study/. 2019
- Miseta, E. How TissueTech managed growth, virtual trials, and survived COVID-19. https://www.clinicalleader.com/doc/how-tissuetech-managed-growth-virtual-trials-and-survived-covid-0001. 2020