With this in mind, we wonder if DCTs are a short-lived reaction to the pandemic or if they will be here to stay. This article will try to answer these questions by exploring the power and potential of DCTs, as well as unpacking the challenges that may need to be overcome.
COVID-19 and the Modernization of Clinical Trials
Conventional clinical trials require participants to attend scheduled visits at clinical research sites, such as hospitals or specialized clinics. DCTs allow trial participants to have digital check-ins instead of in-person visits. This can be done in the individual’s home environment.
Decentralized clinical trials can also involve home visits, direct-to-patient drug delivery, and the use of local healthcare facilities.
The concept of conducting clinical trials without site visits is not new: mail-based randomized trials and phone-call follow-ups have been conducted since the 1980s. The REMOTE trial, conducted in 2011, was the first entirely web-based trial.
Preserving Trial Continuity in Challenging Times
Yet it was the pandemic that generated the real shift towards DCTs. As access to trial sites decreased by 80% within the first few months of the pandemic, sponsors had to quickly make sure trials were continued, while maintaining participant retention and data integrity. As a result, the number of DCTs worldwide more than doubled between 2020 and 2022.
The pharmaceutical industry has noticed this shift. As McKinsey reported in December 2019, 38% of pharma and contract-research organizations (CROs) expected DCTs to form a major part of their portfolios. A year later, 2020, and that percentage jumped to 100%.
Clinical Trials: The Burden of Enrolment
Clinical trials are a necessary pathway for bringing new drugs to market. Typically, trials cost millions of dollars and take an average of 7.5 years to complete. Approximately 30-40% of that time is taken up by participant enrolment.
Despite having a large number of participants at the beginning of a trial, it is not a guarantee of success.
Over 80% of clinical trials report difficulties with participant retention, and one in five clinical trials are terminated early due to declining participant numbers.
If a trial has a high drop-out rate, one way to counteract that is by enrolling more trial participants than necessary. However, this strategy can significantly increase costs.
Patients as the Focus of Decentralized Clinical Trials
One appeal of DCTs is their convenience and simplicity for participants. In the US, many potential trial participants live over two hours from a clinical research site. Reducing travel times can help increase participation in a trial, as well as improve participant diversity, leading to more reliable results.
Decentralizing some trial components, such as using a smartphone to monitor heart rate or having patients bring their own devices to a health clinic, boosts trial recruitment and retention rates.
Studies have demonstrated that involving participants in data collection improves engagement in the trial. Self-reporting and getting direct feedback on results makes participants feel they are the critical factor in the success of the trial, and this patient-centricity provides a better patient experience.
Digital Technology Opening Doors for Clinical Trials
Digital technology has facilitated the transformation of clinical trials in many ways, mainly through teleconferences with healthcare providers (HCPs), web-based questionnaires, online reporting tools such as electronic Clinical Outcome Assessments (eCOA) or electronic Patient Reported Outcomes (ePROs), and real-time patient monitoring using sensors and wearables.
The pandemic may have forced the health industry to adopt new technologies out of necessity, but it has also brought forth a multitude of digital solutions, apps, and platforms.
Digital solutions that are easy to use can collect more data than those specified in clinical trials, often in real time. As the data is delivered directly from the trial participant, data verification steps can be simplified.
Electronic consent forms (or eConsent) for trial participation mean that trial participants can become familiar with the processes and expectations within the comfort of their home and at their own pace. No need to read paper documents on-site. Adding educational content like short videos to eConsent was found to increase participant enrolment, especially among disadvantaged groups.