How technology is making clinical trials more accessible
Decentralized clinical trials (DCTs) are the remote work equivalent of clinical trials for new drug therapies and medical devices. The COVID-19 pandemic caused major disruptions for clinical trials, which typically required regular in-person visits by research participants to a study site, such as a hospital or clinic. As in-person gatherings were restricted during the pandemic, trial sponsors and contract research organizations had to move to remote solutions to protect participants and researchers. As a result, 76% of more than 200 clinical trial sponsors conducted most or all patient monitoring remotely in 2020, up from just 18% in 2019.1
While most people are now back to in-person activities, DCTs are likely here to stay, with trials that are either fully or partially remote. The U.S. Food and Drug Administration issued new guidance in early 2023 that covers everything from design consideration to the use of digital technology and obtaining informed consent from participants for DCTs.
Some of the technologies used to conduct trials remotely aren’t much different from those that help people work from home. Trial participants need secure communication channels to share electronic patient-reported outcomes (ePRO) or to receive information about the trial to give informed consent. They also often need secure video conferencing for telehealth sessions with healthcare providers. The providers themselves may visit participants’ homes, meaning they need access to the participants’ information via a secure mobile device.
Remote patient monitoring is also growing in popularity. These may include wearable devices such as glucose or heart monitors that automatically transmit data to the research team. These IoT devices are the second-most-used virtual technology in DCTs after telemedicine.2 The real-time data from these devices can improve accuracy over participant-reported outcomes.
The addition of connected technology makes security a big concern for all DCTs, as intellectual property and protected health information are attractive to attackers. The large volumes of data being generated and processed need to be transferred and analyzed securely to avoid loss of sensitive data or corruption that could disrupt the study. DCTs are using security solutions from SD-WAN to zero-trust network access to protect their critical data.
Improving Trial Diversity through Technology
Recruiting suitable participants is a major hurdle for clinical trials. A frequently-cited study found that 70% of potential trial participants live more than two hours away from a study center.3 When regular site visits are required, this becomes inconvenient or even impossible for many people, especially those with conditions that limit mobility or their ability to drive. These challenges also lead to trial participants that don’t represent overall demographics. White participants are overrepresented in U.S. clinical trials compared to U.S. census data, as are people under age 65.4
In a study of current and former cancer patients, the majority said they’d be more likely to enroll in a clinical trial if the participation-related time and travel burden decreased.5 Researchers hope DCTs can attract a more diverse participant pool who lack the schedule flexibility or transportation required for traditional clinical trials.
Faster Trials and Larger ROI
Clinical trials are generally a long process. Phase 2 trials often take three to four years while phase 3 trials (the final step) take four to five years. A study found DCTs were completed much faster than traditional trials: 246 days faster for phase 2 and 360 days faster for phase 3.6 Reasons cited included lower screen failure rates (when someone completes the screening process but doesn’t enroll), lower dropout rates, and fewer amendments to the study. The study also found that a 10% shorter trial cycle results in a 5x ROI and $10 million increase in expected net present value.7
If you’re interested in participating in a clinical trial to help further medical research, you can find a database of studies in over 200 countries at clinicaltrials.gov.
- Florence, 2021 State of Clinical Trial Technology Industry Report, May 2021
- Clinical Trials Arena, Digital clinical trials: Trends to watch in 2023, April 2023
- Fierce Biotech, Sanofi launches new virtual trials offering with Science 37, March 2017
- Flores LE, et al. Assessment of the Inclusion of Racial/Ethnic Minority, Female, and Older Individuals in Vaccine Clinical Trials, JAMA Network Open, February 2021
- Adams DV, Long S, Fleury ME, Association of Remote Technology Use and Other Decentralization Tools With Patient Likelihood to Enroll in Cancer Clinical Trials, JAMA Network Open, July 2022
- Clinical Research News, Tufts Study Provides ‘First Hard Metrics’ Around Decentralized Clinical Trials, July 2022
- Ibid.
