It’s no secret that clinical trials have struggled to adequately reflect changing demographics and real-world patient populations. White Americans represent 61.6% of the population, the FDA reports that 75% of participants in 2020 clinical trials that resulted in the approval of novel drugs were White. Only 2% of clinical trial participants identify as African American, and less than 5% as Latinx. And yet, people of color suffer from significantly higher rates of chronic disease and mortality than their White counterparts, demonstrating the need for therapeutics tested for efficacy within marginalized communities.
In our recent webinar, “There’s No Place Like Home… to Conduct Decentralized Clinical Trials,” Marcia Brown-Rayford, VP of Global Life Sciences and R&D Leader at RGP and R’Kes Starling, CEO of Reveles Clinical Services, explored how decentralizing clinical trials with digital health technologies and home-based services can help researchers overcome barriers to recruitment, retention, data collection, and integration —enhancing clinical data quality and study outcomes.
Despite the historical challenges to adopting advanced digital platforms and technologies in healthcare, COVID-19 has been the key igniter driving the use of technology in the rapidly growing DCT world. The clinical trials industry continued to move towards a decentralized model when patients could no longer travel to sites for participation. As a result, leveraging technology was paramount in sustaining those clinical trials that weren’t delayed or canceled altogether. While hurdles to adoption still exist, digital technologies are undoubtedly transforming the way clinical trials are designed and implemented in multifaceted ways.
Removing Barriers to Recruitment, Retention, and Trial Success
Decentralizing clinical trials reduce barriers to patient participation, allowing researchers and study sites to cast a broader net while also endeavoring to improve the patient experience and alleviate the patient burden. This is particularly helpful for patients with rare diseases who may benefit from a treatment through research and yet be unable to find a nearby trial. Reaching patients in remote regions that are located far distances from clinical research sites expands the available patient pool and can help not only accelerate recruitment but also sustain trial enrollees.
For patients, DCTs reduce the time commitment, along with the need and potential complexity of traveling to and from sites, increasing their likelihood of continuing in the study once enrolled. The ability to participate from the comfort of their own home also can mitigate trust issues within patient populations that have experienced historic unfair, unsafe mistreatment from medical and research professionals as encountered in the Tuskegee Airmen Experiment, the Havasupai diabetes project, and others. Seventy-five percent of potential trial participants surveyed by Tufts reported being open to having a nurse come to their home or collecting their own data through such digital enablements as electronic patient-reported outcomes (ePRO) and direct data capture (DDC) platforms.
Advancements in digital health technologies, like the availability of wearables for data collection, have made this possible. Supported by distributed networks of nurses for at-home lab collection, drug administration, and more, along with blockchain-enabled direct shipping and delivery of drug products. These digital advancements can greatly reduce the need for patients to travel to a research site for trial-related treatment, monitoring and to collect quality data. The interoperability of advanced digital platforms can further enable making DCTs faster and more efficient in bringing technological and therapeutic innovations to the participating clinical patients – one home and one trial at a time.
We discussed these topics and more in our recent webinar.
Watch the video below to learn:
- The difference between traditional and decentralized clinical trials
- How digital technologies can assist with recruitment, retention, and DE&I in clinical trials
- Ways block-chain solutions are changing how at-home DCTs are conducted
- Effective approaches to technology interoperability in DCTs, and their benefits
- Best practices for conducting DCTs, including patient engagement strategies