Virtual or remote clinical trials (decentralized clinical trials or DCT) became a necessity during COVID-19. In the beginning of 2023 it was predicted that the majority of trials will integrate at least some features of the DCT technology right from the beginning of trial design. Experts suggested that the conversation will be more on what aspects of a clinical trial can be decentralized, rather than whether or not to use DCT technology. Moreover, a study from the Tufts CSDD showed that impressive return on investments achieved by DCTs will accelerate the adoption of DCTs. The study found that DCTs can achieve net financial benefits ranging from 5-13 times, equating to a ROI of roughly $10 million for Phase 1 and $39 million for Phase II trials. Moreover it predicted that the time saving for study teams and benefits of increased access and convenience for participants will compel sites and sponsors to leverage a variety of tools of the DCT technology. 

Fast forward to mid 2023, the U.S. Food and Drug Administration (USFDA) released a draft guidance in May 2023 supporting the use of DCTs for drugs, biologics and devices, where some or all the trial-related activities occur at locations other than traditional clinical trial sites. It provides recommendations for sponsors, investigators and other stakeholders regarding the implementation of DCTs to advance medical product development and research. The draft guidance also encourages use of some elements of “digital” in clinical trials, for example, use of telemedicine for follow up visits, use of apps and wearable devices to collect study data remotely including conducting lab tests at local facilities rather than a research medical center. 

Presentations on digital therapeutics took centerstage with AI being at the forefront of many discussions at the recently held Digital Health Innovation Summit in San Francisco which connected thought leaders from Pharma, Healthcare, and the MedTech industry. Similarly, recently held DIA2023 covered several sessions on DCT with topics ranging from impact of DCTs, oversight and responsibility insights, regulatory insights, including thoughts of patients and care partners about DCT. 

Here’s How DCTs are changing the patient landscape?

Decentralization of trials is often referred to as “patient-centric”, and rightly so. Here, the fundamental operations, such as recruitment, engagement, data capture, etc., are brought together using technology. The facilities are built around patients rather than the research sites. This type of modular framework in DCTs, involving apps, automated reminders and tracking, makes it easy not only for patients but also for the site staff and sponsors in terms of speed, compliance and efficiency.

Here are some aspects of DCTs that can transform the existing patient landscape.

1. Decentralization and hybrid modes offer flexibility and enable patients to choose a method of care that suits their circumstances and health conditions. Enhancing the patient experience is likely to lead to (a) improved retention and reduction in patient drop out rates and (b) increased patient-to-patient referrals, as opposed to only physician referrals in conventional trials. 
2. Technologies such as telemedicine and home health services allow better accessibility, reduces the risk of exposure, lessens travel burden, and provides convenience for participants.
3. The use of electronic data collection and reporting methods, such as direct data capture (eSource), electronic informed consent form (eICF), electronic patient reported outcomes (ePRO), and electronic diary (eDiary) can improve patient engagement and management.
4. Virtual doctor-patient interactions can occur more frequently and at times and locations suitable for the participant, thereby improving compliance and protocol adherence. However, engagement strategies must emphasize regular communications with patients, caregivers, and advocates to understand each patient’s trial experience and challenges.
5. DCT’s have the potential to improve inclusion and diversity. Patient recruitment is now possible from new geographic locations, including remote communities and cross-border regions which were previously less served due to inaccessibility to the sites. This can result in a more diverse patient pool, strengthening the validity of clinical data.
6. DCTs offer cost benefits and a wider reach for patient recruitment companies. Study teams can share their clinical trials on digital channels that can reach a wider audience. Moreover, patients may be more receptive to digital advertising.      

Overall, a DCT approach has the potential to speed up patient enrollment and expedite the trial. Making digital a priority, has gone from a nice-to-have to must have. More and more companies running trials are now realizing the benefit in streamlining the clinical trials process, providing better data, reducing in-clinic time burden, speeding up recruitment and reducing pre-screen failures and associated costs. 

How is TrialX facilitating decentralized clinical research on earth and in space?

TrialX xPAND is enabling decentralized clinical research here on earth and in space. In addition to helping clinical trials investigators collect study data remotely, we are proud to support pre and post flight data collection for historic space missions such as Axiom-2. EXPAND DB – the database built for TRISH using TrialX xPAND, is the first database of human health & environmental data from commercial space flights designed to support a variety of data types across a multitude of individual research studies. The database currently houses data from subjects across five space missions – Inspiration 4, MS-20, Axiom-1, Axiom-2 and Polaris Dawn. TrialX xPAND database equips space researchers to reuse and integrate research data across different research studies and unlock innovative actionable insights.