Technology-Enabled Clinical Trials: Transforming Medical Evidence Generation.

The complexity and costs associated with traditional randomized, controlled trials have increased exponentially over time, and now threaten to stifle the development of new drugs and devices. Nevertheless, the growing use of electronic health records, mobile applications, and wearable devices offers significant promise for transforming clinical trials, making them more pragmatic and efficient. However, many challenges must be overcome before these innovations can be implemented routinely in randomized, controlled trial operations. In October of 2018, a diverse stakeholder group convened in Washington, DC, to examine how electronic health record, mobile, and wearable technologies could be applied to clinical trials. The group specifically examined how these technologies might streamline the execution of clinical trial components, delineated innovative trial designs facilitated by technological developments, identified barriers to implementation, and determined the optimal frameworks needed for regulatory oversight. The group concluded that the application of novel technologies to clinical trials provided enormous potential, yet these changes needed to be iterative and facilitated by continuous learning and pilot studies.

Opportunities and counterintuitive challenges for decentralized clinical trials to broaden participant inclusion.

Traditional clinical trials have often failed to recruit representative participant populations. Just 5% of eligible patients participate in clinical research. Participants, particularly those from minority groups, cite geographical constraints, mistrust, miscommunication, and discrimination as barriers. Here, an intersectional view of inclusion in clinical trials provides significant insights into the complex and counterintuitive challenges of trial design and participant recruitment. The US FDA have recently proposed that decentralized clinical trials (DCTs) might reduce barriers and appeal to a wider range of participants by reducing the costs and commitments required for patients to participate. While common sense and early evidence suggests that allowing participants to take part in trials at or near home has advantages in terms of convenience, travel, and perhaps even infection control, it remains to be seen if DCT approaches will yield significant improvements on participant inclusivity. Some digital studies aiming to be more inclusive on a single element of inclusion, such as race, have experienced unintended consequences in other elements, like education or gender. Implementing DCTs presents new challenges including the digital divide, the exclusion of certain tests and procedures, complexities of at-home medication delivery, and the need to build new infrastructure. We present a range of challenges and opportunities for researchers to adopt and adapt DCT approaches to create reliable evidence that applies to all of us.

Current status of hypnotic prescribing habits in the United States.

Prescription data suggests that outside of primary care physicians, psychiatrists represent the second largest prescriber of sleep aids, accounting for 11 percent of total prescriptions. Use of individual agents do not differ between psychiatrists, primary care physicians, and neurologists.