Contract research organization (CRO) Rho has joined the Decentralized Trials and Research Alliance (DTRA). The group is designed to bring together life science and healthcare organizations (50 to date) to accelerate the adoption of patient-focused decentralized clinical research.
According to organizers, the DTRA will welcome healthcare firms, regulators, patient groups, and research organizations. The stated mission is to increase the accessibility of clinical trial participation through advancement of policies, practice and digital technologies in studies.
Matt Healy, vice president of clinical operations with Rho, told Outsourcing-Pharma that the DTRA will help trial professionals better plan and organize their studies, especially when it comes to data.
“One of the challenges, with implementing a decentralized or hybrid approach, is understanding and having a plan for how data will be received, e.g., in real time or near-real time, and how it will be integrated and analyzed),” he explained. “For example, wearables have the ability to generate a large amount of data in short periods of time; understanding how that data is going to be used to support the success of a trial is important.”
Additionally, Healy commented, it is important for trials to consider a risk-based quality management (RBQM) approach, with a plan that fits with the studies, and to be flexible in adapting to the needs of various kinds of trials.
“It is also important to understand that different types of trials may require different solutions,” Healy added. “A fast-enrolling pain study may be managed very differently than a long-term rare disease trial.”
Further, Healy explained, the strain the COVID-19 pandemic has placed on the trial industry has caused research professionals to increasingly pursue decentralized options. While the surge continues, researchers are looking for ways maintain the safety of participants, as well as the quality and integrity of data.
“The decentralized trial solutions being implemented today are certainly going to persist following the resolution of the COVID-19 pandemic,” he said. "Sponsors and CROs, as well as investigative sites, will assess how the mitigations put in place during the pandemic served their trials and how trials will be designed and executed going forward.”
Amir Kalali, co-convener of DTRA and founder of several collaborative life science communities, said, “By advancing decentralized research, we can make the clinical trial process more patient-focused, increase trial efficiency and encourage use of technologies. We are excited by Rho’s commitment to embracing decentralized trials and changing the culture that has been a constant rate limiter to innovation.”
Craig Lipset, Kalali’s fellow co-convener, said the DTRA will enable companies to share ideas that could help “chart the future course” of decentralized trials.
“We have a responsibility to advance the health of people with unmet medical needs, and by convening stakeholders from pharma companies, regulators, technology leaders and patient communities, we can remove remaining barriers to adoption and impact patients today,” Lipset said.”