The rapid adoption of decentralized clinical trials (DCTs), also known as remote clinical trials, has revolutionized pharmaceutical research and the approach taken by clinical operations teams in conducting their clinical trials.
While such changes began prior to the pandemic, COVID-19 accelerated this trend, allowing clinical research and drug development to continue in an era of social distancing.
With the pandemic over, this new paradigm of decentralized trials is becoming the mainstay across the pharmaceutical and health sciences sectors. Why? That’s what we’re exploring in this article.
In this article:
What are Decentralized Clinical Trials (DCTs)?
In a traditional clinical trial, investigators establish sites in key locations. Patients recruited into the trial must then attend these sites (site visits) for testing, evaluation, and treatments.
However, electronic data capture (EDC) allows investigators and researchers to collect and analyze data remotely. Patients no longer need to attend the site; decentralized trials harness commonplace technologies like smartphones, health wearables, and tablets to monitor symptoms, complete enrollment and consent, and even collect more data than under traditional circumstances.
Pfizer was among the first to trial DCTs in 2011, conducting the first-ever “virtual” clinical trial1. Uptake was slow in the years after but accelerated as technologies advanced and the pandemic forced the change.
So, what are the key benefits of remote clinical trials? And why are they the future of clinical research?
1. Real-Time Data Collection
Rather than sacrificing data collection for convenience, EDC allows for ever greater data capture. Real-world, continuous data collection through health wearables provides a trove of realistic, accurate data outside of the artificial clinical setting.
Moreover, continuous monitoring can detect fluctuations in a patient’s symptoms or vitals previously unnoticeable under conventional practices—for example, changes in blood pressure during sleep, long-term trends in sleep patterns, or daily fluxes in blood glucose monitoring.
Indeed, even basic wearables like Fitbit, Omron, and Dexcom collect everything from heart rate, sleep analysis, blood pressure, glucose levels, activity, and more.
2. Reduced Travel Times
Accessibility is a critical battle in all clinical trials. Remote or under-served areas are often ignored and neglected when conducting a trial. That’s possible for large treatment populations, e.g., diabetes mellitus or breast cancer. However, when dealing with rare diseases, investigators must cater to patients wherever they are based. Usually, that meant paying for travel costs and hotel stays to attend site visits.
Currently, trial participants travel 67 miles one way, on average, to visit clinical trial sites; and rare disease patients travel 135 miles to sites2.
Decentralized clinical trials do away with this hassle. Trial populations can live anywhere and participate with ease. And, if necessary, the few in-person visits required can occur at the participants’ homes rather than forcing them to travel to the site.
Some trial testing, such as sleep studies, even required patients to stay overnight in a hospital. As an experienced endocrinologist (working in a high-profile hospital) noted, nocturnal monitoring is easier than ever through remote monitoring. It also allows researchers to compare sleep data to exercise data and other day-time information to look for correlations – all without hospitalizing the patient.
3. Lower Trial Costs
DCTs don’t just eliminate the need for site visits; they eliminate sites altogether. Site selection and establishment is a critical element that slows down clinical trials. No rent, utilities, or on-site staff means trials can be conducted at a fraction of their original cost. Indeed, administrative staff costs represent 11% to 29% of the total trial budget, while site monitoring costs added a further 9% to 14%3.
Meanwhile, reduced travel expenses and increased convenience for patients work synchronously to improve patient retention. Not only does that reduce costs, but it also speeds up patient recruitment – one of the costliest elements of all clinical trials: approximately 10% of a trial’s budget4.
In the “first hard metrics” analysis of decentralized clinical trials, Tufts identified key economic savings from reduced cycle times, improved patient screening and enrollment, and fewer protocol amendments5. Consider that the cost of delay per day can range from $600,000 to $8 million, and the benefits are staggering6.
4. Larger Patient Populations
Fewer overheads and lower costs per participant allow trials, if necessary, to recruit larger patient populations. That’s especially helpful in rare disease trials where the costs of site visits prohibitively impact recruitment.
Such trials can improve their overall statistical power and increase the diversity of the patient population. This, in turn, enhances the external validity of the trial, making it more representative of the real-world population.
Furthermore, enabling the inclusion of participants from different geographical locations, such as rural or underserved regions, broadens the recruitment base. Indeed, WEIRD (Western, Educated, Industrialized, Rich, and Democratic) populations have long been noted to differ in everything from behavior to diet compared to the rest of the world7.
5. Improve Participant Retention
Participants want to help. But clinical trials don’t exactly make life easy for them. With patient location no longer a factor, convenience can take the driving seat. No matter the disease under study, investigators and researchers can design trials around the participant – not the other way around.
Participating, after all, no longer involves a several-hour round trip but little more than wearing a device 24/7 and answering the phone every week or so.
The analysis by Tufts noted lower screen failure rates and lower dropout rates as key benefits of DCTs5. And lower dropout rates mean, for most trials, fewer patients are required in the first place.
Final Thoughts
Decentralized clinical trials are revolutionizing the clinical research landscape, enabling greater patient accessibility, data collection, and overall cost-efficiency.
To simplify your transition to DCTs, consider CDConnect, our user-friendly electronic data capture system designed to integrate data from popular health wearables seamlessly. Harness the power of remote monitoring clinical trials with CDConnect – your easy-to-use solution for efficient and effective data capture. Get in touch to learn more today.
Sources:
- https://www.medable.com/knowledge-center/guides-back-to-basics-what-is-a-decentralized-clinical-trial
- https://www.outsourcing-pharma.com/Article/2022/11/09/clinical-trial-participants-travel-67-miles-to-study-sites-on-average-analysis-finds
- Sertkaya A, Wong HH, Jessup A, Beleche T. Key cost drivers of pharmaceutical clinical trials in the United States. Clinical Trials. 2016 Apr;13(2):117-26.
- https://www.clinithink.com/white-papers/a-paradigm-shift-in-patient-recruitment-for-clinical-trials
- DiMasi JA, Smith Z, Oakley-Girvan I, Mackinnon A, Costello M, Tenaerts P, Getz KA. Assessing the Financial Value of Decentralized Clinical Trials. Therapeutic Innovation & Regulatory Science. 2023 Mar;57(2):209-19.
- https://pharmafile.com/features/clinical-trials-and-their-patients-rising-costs-and-how-stem-loss/
- Gurven MD, Lieberman DE. WEIRD bodies: mismatch, medicine and missing diversity. Evolution and Human Behavior. 2020 Sep 1;41(5):330-40.
