One of the most notable impacts of the COVID-19 pandemic on the biopharma industry has been on the conduct of clinical trials, with clinical research disrupted worldwide as a result of the virus’ global spread. According to a recent Lancet article, patient enrollment was either halted or paused this spring in 80% of non-COVID-19-related studies, with only some patients already enrolled continuing to receive treatment.
The main driver of this: patient safety, especially for the many who were already immunocompromised and could be put at risk of exposure to the virus by visiting hospitals or study centers. FDA guidelines on clinical trials issued in March and updated in July mandated that patient safety be the foremost consideration, even if studies needed to be discontinued to reduce patient risk.
As a result of the pandemic’s constraints on traditional clinical trials and the deleterious effects that such delays have had on development timelines, companies have been driven to re-consider how clinical research is performed. One consequence is that a slowly growing trend towards decentralized trials has significantly accelerated. Life science data analytics firm GlobalData recently reported that 67% of those conducting or sponsoring clinical research either use or plan to use decentralized trials in the near future, almost twice as many as before the pandemic. Decentralized trials are those conducted remotely, allowing patients to remain at home during much or all of the study. In many cases, patient recruitment and informed consent are being accomplished remotely. Often, physician visits are made via telehealth or using local/mobile healthcare providers, and remote patient monitoring technologies are enabling significant amounts of data gathering at a distance.
Helping to speed the adoption of these methods, regulators have eased some clinical trial restrictions during the COVID-19 pandemic to accommodate its many challenges and put patient safety foremost. In particular, FDA Guidance has encouraged the use of decentralized methods for procedures like informed consent and sets out advice for addressing and reporting protocol changes, as well as explaining missing data and other aspects of a clinical trial likely to be affected by the pandemic. It remains uncertain, however, what the regulations governing decentralized clinical trials may look like post-COVID-19.
But the advantages of decentralized trials go far beyond reducing the risks of viral exposure during a pandemic. Such trials are much more patient-centric and can greatly increase patient access and improve their experience. Because the patient doesn’t need to visit the trial site as frequently (if at all), scheduling and travel burden to patients, families, and caregivers are drastically reduced. More patients with mobility issues, such as the elderly or those living far from a trial site, can still participate, enabling some trials to take on a more global format. The greater patient access may especially benefit recruitment for rare disease studies by potentially lowering the disruption to patients’ and families’ everyday life, as well as reducing financial burdens of trial participation. For companies, the greater ease for patients taking part in decentralized trials also has the potential to increase the diversity of those who enroll (not only geographically, but also by economic, social/ethnic, and other factors), as well as improve patient retention. Decentralized trials may also help reduce costs to both drug developers and trial sites compared to traditional trials.
Challenges do remain. Some of these relate to the logistics of distributing investigational products to remote locations, and issues around overseeing compliance and study procedures when patients are treated and evaluated in their own home, rather than during a site visit. There may also be issues relating to validation of the specific devices employed, connectivity, reliability and robustness of data, as well as concerns about data privacy.
Many of these concerns are being addressed through new technologies and collaborations, such as the partnership between Medable, Covance, and Datavant, to develop platforms aimed at better informing and more securely connecting patients, investigators and trial sites, and sponsors. Even blood drawing, traditionally performed during a laboratory visit, can now be painlessly performed by a patient in their home through a device developed by Tasso, Inc.
We believe that decentralized trials are here to stay. We expect companies to increasingly adopt such strategies outright or incorporate them in hybrid formats combining traditional and decentralized approaches – both to continue and protect patients in cases of another pandemic, but even more as a means of improving patient representation and, potentially, reducing the time and cost of clinical trials overall. This is especially true for studies in diseases where the barriers to remote monitoring are low, such as in diabetes where connected devices are already a routine part of patient management, at least for type 1 diabetes, or where such monitoring can enhance patient evaluation and participation, such as for movement disorders (e.g., multiple sclerosis and Parkinson’s disease).
We encourage the FDA and other regulators, as well as policy makers, to embrace the idea of decentralized clinical trials and continue supporting and promoting them even post-COVID-19. A clearer roadmap will enable companies to better plan and more quickly advance their adoption of these strategies, which have the potential of benefiting patients and drug developers alike. In parallel, we believe pharma and biotech companies should research and invest in technologies that support decentralized clinical trials, including patient monitoring devices and digital biomarkers that have the potential to enable superior data collection.