Sometimes it takes an unprecedented event to drive positive change. In the case of clinical trials, the COVID-19 pandemic did just that – turning the assumption on its head that patients had to be physically present at a hospital or research center for a clinical trial to progress in a safe, reliable and compliant manner.
In a matter of weeks and months in 2020, clinical trial sponsors had to switch to remote trials, also known as decentralized clinical trials (DCTs). Though DCTs have been in practice for more than 20 years, when faced with few other options, sponsors accelerated their use which ultimately lead to widespread acceptance that this process is efficient and that patients had a positive experience. Analysis by McKinsey found that almost three-quarters of physicians reported similar or better experiences with remote engagement compared to in-person visits. Up to 98% of patients reported being satisfied with telemedicine.
Also known as hybrid trials, virtual(ized) clinical trials, remote trials, and direct-to-patient trials, at its core a DCT allows many elements of a clinical trial to be carried out remotely, rather than requiring patients to travel to a central clinical facility. The Association of Clinical Research Organizations (ACRO), which represents global clinical research and technology organizations, described a decentralized clinical trial as one that:
“Brings the trial to the patient by utilizing local healthcare providers, optimizing digital health technologies, and enabling the voice of the patient in order to accelerate medical product development, speed delivery of therapies to patients, and create efficiencies across clinical research processes.”
According to the US Food and Drug Administration (FDA), a decentralized clinical trial is where some or all the trial-related activities occur at a location separate from the investigator’s location.
What are the benefits of decentralized clinical trials?
By doing things differently, whether that’s switching from face to face to video call assessments, enabling remote patient consent and monitoring, or dispensing therapies and drugs at the patient’s home, decentralized clinical trials allow organizers to remove barriers that traditionally stood in the way of people taking part.
With a decentralized clinical trial, it’s no longer an issue if a patient lives too far away, even if they’re in a different country, from a research center. Patients that were unable to attend regular in-person appointments can participate from home instead.
When you consider that 85% of clinical trials fail to retain enough patients and the average dropout rate hovers around 30%, the need reduce the burden on patients and improve the overall experience is clear. Through decentralized clinical trials, researchers are able to:
- Broaden clinical trial access to a wider number of patients
- Engage a more diverse range of patients
- Reduce the burden and time commitment required of patients
- Accelerate participant recruitment and improve retention rates
- Improve data quality and continuity across the entire clinical trial process.
How do digital health technologies make decentralized clinical trials possible?
Industry regulatory bodies like the FDA have begun to put guidance in place to support decentralized clinical trials, focused particularly on the digital health technologies required to facilitate the entire process, including cloud-based data platforms, advanced medical devices and sensors.
In its latest guidance, the FDA asks clinical trial investigators and sponsors to ensure, among other things, that the technology is suitable and easy for the trial population to use and that it delivers comprehensive data privacy and security.
Dassault Systèmes Medidata is at the forefront of the transition to decentralized clinical trials. Medidata ran the first DCT with Pfizer over 20 years ago. It supports the largest fully virtual DCT, the ADAPTABLE study, and it supported the clinical trials for Moderna’s COVID-19 vaccine. Medidata’s mission is to transform clinical development across the globe. The Medidata Decentralized Clinical Trials Program delivers all the capabilities required to support fully decentralized or hybrid clinical studies, covering:
- Technology and workflows to virtually manage patient participation
- Full data monitoring and oversight activities to ensure patient safety and data integrity
- Direct-to-patient services, including drug dispensation and supply management.
“Every aspect of clinical trials — the life-blood of life sciences — is being transformed by technological innovation,” Rama Kondru, co-CEO and head of R&D at Dassault Systèmes Medidata, wrote in a Compass column. “Today, we can more effectively recruit and onboard patients, manage trial supplies and collect, analyze and protect data. Behind these improvements are robust, collaborative, cloud-based platforms that eliminate the myriad of challenges that thwarted past trials.”
By bringing together the technology and workflows required to support the remote clinical trial experience for patients, sites and sponsors, Medidata is able to capture and monitor all data across a clinical trial, helping to enhance data quality, ensure patient safety and deliver the insights that lead to better research and patient outcomes.
Scaling up patient-centric decentralized trials
Medidata recently supported the first fully decentralized clinical mega-trial, called ADAPTABLE (Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-term Effectiveness), led by researchers at the Duke Clinical Research Institute (DCRI). Using Medidata’s technology, ADAPTABLE was able to enroll thousands of patients at a scale never seen before without requiring anywhere near the usual number of clinical sites.
“When compared with traditional cardiovascular trials that engage hundreds or thousands of sites, this technology allowed us to enroll 15,000 participants from 40 centers,” said Dr. Schuyler Jones, ADAPTABLE co-principal investigator and associate professor of medicine at Duke University Medical Center, in a press release.
The ADAPTABLE team said the decentralized trial not only saved significant time and money, but also shifted the role of the patient from participant to partner. This shift is indicative of a wider trend towards patient-centric healthcare, as consumer expectations continue to evolve and healthcare providers seek new ways of engaging patients.
According to ACRO, the convenience of a decentralized approach “will lead to improved recruitment and participation, ultimately benefiting both participants, drug developers and future patients in the longer term.”
