Decentralized Clinical Trials: A New Era in Patient-Centered Research

 

Decentralized Clinical Trials (DCTs) are reshaping the landscape of clinical research by allowing participants to engage in studies without the need to visit traditional trial sites. DCTs, powered by technology like telemedicine, mobile apps, wearables, and remote monitoring, do research directly at the patient's home. As the pandemic altered travel possibilities, other models had to be looked into. 

According to Petrini et al. (2022), DCTs essentially place clinical trial interventions in the participant's home or locality as opposed to centralized trial sites. Such trials enhance the scope of flexibility, reduce logistical encumbrances, and perhaps increase visits to underrepresented groups or geographically distant populations. These trials basically serve as a proof of concept-the intervention was allowed by regulators because of the pandemic, temporarily to collect data remotely and deliver investigational drugs at home.

Ethical challenges exist in the DCTs as well. With the traditional face-to-face approach no longer used, the complexity of informed consent is increasing on the digital side. For patients to make decisions, they must thoroughly understand what they are agreeing to, especially vulnerable groups. Privacy is another issue since more actors (couriers, tech vendors) gain access to personal health information. Then there's another issue of the digital divide that might exclude participants lacking internet access or technology. Ethics committees face added complexity when reviewing DCTs, as highlighted by van Rijssel et al. (2022), who found that reviewers were often unsure how to assess the quality and validity of remote data collection methods.

In spite of such concerns, studies evidence that decentralized clinical trials could improve clinical outcomes. In 2020, a virtual trial on atopic dermatitis by Ali et al. demonstrated good adherence and minimal attrition rates. Patients preferred the convenience of participation from home and were positively engaged when there was digital literacy-based support and personalized communication. These results highlight the possibilities of DCTs to improve patient experience and retention.

Nevertheless, some trials remain ill-suited for decentralization. Some clinical procedures may require working with a subject in person or performing certain types of lab-based diagnostics. Hence, hybrid trials-from-the-site-to-distal-became increasingly popular. To enable ethical and successful DCT application, regulators, sponsors, and researchers should cooperate towards a widely accepted framework for best practices and to address issues of equity.

In summary, decentralized clinical trials seem to promise a more accessible, inclusive, and patient-centered future of research. Proper ethical oversight and technological support could allow DCTs to be a permanent research modality-that in essence bridges the gap between science and everyday life.

REFERENCES:

• Petrini, C., Mannelli, C., Riva, L., Gainotti, S., & Gussoni, G. (2022). Decentralized clinical trials (DCTs): A few ethical considerations. Frontiers in Public Health, 10, 1081150. https://doi.org/10.3389/fpubh.2022.1081150

• Van Rijssel, T. I., de Jong, A. J., Santa-Ana-Tellez, Y., Boeckhout, M., Zuidgeest, M. G. P., & van Thiel, G. J. (2022). Ethics review of decentralized clinical trials (DCTs): Results of a mock ethics review. Drug Discovery Today, 27(10), 103326. https://doi.org/10.1016/j.drudis.2022.07.011

• Ali, Z., Anderson, K., Chiriac, A., Andersen, A. D., Isberg, A. P., Moreno, F. G., et al. (2020). High adherence and low dropout rate in a virtual clinical study of atopic dermatitis through weekly reward-based personalized genetic lifestyle reports. PLoS ONE, 15(7), e0235500. https://doi.org/10.1371/journal.pone.0235500