Curebase thought leaders look ahead to 2023
By: Jane Myles, VP of Clinical Trial Innovation, Sean Lynch VP of Clinical Operations, and Whitney Stewart, Director of Clinical Project Management at Curebase
In 2023 the decentralized clinical trial industry is expected to accelerate the adoption of patient-centric technology and approaches. As regulators continue to engage more deeply with the industry on the understanding of what decentralized clinical trial (DCT) actually means, better guidance and guardrails will continue to be put forth. As a result, major players in commercial pharmacies will be able to further enter the more regulated DCT space. Not only will this expand the DCT industry, but more importantly, patients will have better access to care options and opportunities to participate in trials.
Regulations and standardizations
The future of decentralized clinical trials will become clearer as the industry evolves and as governing bodies clarify regulations around the globe. This past year there has been a push for more industry-aligned guidance throughout the modern clinical trials space. we’ve seen the Decentralized Trials & Research Alliance (DTRA) put forth a glossary to unify terminology among stakeholders as well as the Digital Therapeutics Alliance (DTA)’s release of a whitepaper, in partnership with Curebase, on Setting the Stage for a Fit-For-Purpose DTx Evidentiary Standard. This trend is far from over.
As we move into the new year, we can expect a series of guidance documents in the digital therapeutics (DTx) space standardizing methods, helping navigate regulatory compliance, and aiding in overall industry alignment from DTx industry leaders such as the DTA. Furthermore, the release of ICH E6 will distill many aspects of data expectations and standards. The more the industry can align on terminology, standards, and regulations, the better the likelihood for important advancements in the DCT space.
We will likely see our industry continue to shift to running more patient-centric trials. Over the past year, some of the largest dispensing commercial pharmacies in the world have moved into the DCT space, as patients are proving to prioritize location alongside technology solutions, to simplify participation.
Patients will continue to seek trial options with functions like online data entry, telehealth, and utilizing local providers. The industry is quickly learning that a patient-centered approach is necessary, as are results in improved compliance, recruitment, participant diversity, and speed to completion. The complexity of the evolving modern trial landscape, combined with prioritizing patient needs, means that a one-size-fits-all approach is no longer possible. In the new year, focusing on the needs of patients and their experiences will continue to bring players with widely distributed locations into the industry.
Sites and vendors
DCT vendors have also begun leveraging smaller more research-naive practices that have strong relationships with patients to participate as sites in clinical trials. In order for these practices to participate in trials, however, they need to be properly supported by sponsors and vendors. These practices can and have been used to successfully recruit qualified patients to clinical trials for oncology, acute illness diagnostics, and many others.
In 2023 we will only continue to see success in leveraging site networks made up of local care facilities of all sizes to recruit and run clinical trials. The site landscape for clinical trial conduct will continue to evolve with new players like Walgreens, Walmart, Best Buy, etc. getting involved. These large-scale commercial players entering the clinical landscape will rapidly evolve how trials are conducted.
Take a look at Curebase’s end-of-year recap to learn about some of the notable accomplishments, milestones, and highlights of 2022 that have accelerated Curebase’s growth, impacted the industry, and furthered the company mission.