The FDA’s new draft guidance on Decentralized Clinical Trials (DCTs) is a landmark moment for the industry, emphasizing the importance of virtual trials for improving patient access to groundbreaking research while providing recommendations on how to incorporate remote trial elements safely. In this new guidance, the FDA encourages the use of remote clinical trial visits and clinical trial-related activities as important strategies to make trials more convenient and more accessible to participants. The FDA also underscores the need for sponsors to work with experienced vendors that can help navigate the complexities of DCTs while ensuring the safety of participants and the integrity of the trial data.
The FDA acknowledges that DCTs offer significant benefits, but they also require careful planning and coordination. Clinical trial sponsors need to consider unique aspects of virtual trials and ensure appropriate oversight. The guidance highlights the importance of collecting accurate, complete, and reliable data, ensuring data privacy and security, and using mobile health technologies effectively. To facilitate virtual clinical trials, specific plans must be in place, such as utilizing local healthcare facilities, local healthcare professionals, and local labs, as well as visits to participants’ homes and direct distribution of the investigational medicinal product (IMP). Appropriate training and oversight are critical to successfully implement a decentralized clinical trial.
The FDA further recommends the use of DCTs to help increase diversity in clinical trials. By utilizing outreach through local healthcare institutions and bringing trials to participants’ homes, the need for travel is reduced, and potential participants who have difficulty accessing traditional research sites can be better engaged. Additionally, the use of local HCPs may improve diversity in trial populations and reduce cultural or linguistic barriers to participation.
DCTs are no longer just a novelty or an experimental approach but a legitimate and encouraged approach to clinical trial conduct. Virtual clinical trials enhance patient participation while reducing patient burden, ultimately providing a more flexible trial model. The successful implementation of these trials requires a well-trained team that can navigate the complexities of remote study conduct and ensure the quality and integrity of the data collected.
With the FDA’s acceptance and encouragement of decentralized trials, we can expect to see a continued shift towards remote trial conduct, virtual sites, and the use of innovative digital technologies. As the industry continues to embrace these advancements, we can look forward to a future where clinical research is more accessible, patient-centered, and ultimately more successful in delivering breakthrough therapies to those who need them most.
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