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Clinical trial processes are unnecessarily inefficient and costly, slowing the translation of medical discoveries into treatments for people living with disease. To reduce redundancies and inefficiencies, a group of clinical trial experts developed a framework for clinical trial site readiness based on existing trial site qualifications from sponsors. The site readiness practices are encompassed within six domains: research team, infrastructure, study management, data collection and management, quality oversight, and ethics and safety. Implementation of this framework for clinical trial sites would reduce inefficiencies in trial conduct and help prepare new sites to enter the clinical trials enterprise, with the potential to improve the reach of clinical trials to underserved communities. Moreover, the framework holds benefits for trial sponsors, contract research organizations, trade associations, trial participants, and the public. For novice sites considering future trials, we provide a framework for site preparation and the engagement of stakeholders. For experienced sites, the framework can be used to assess current practices and inform and engage sponsors, staff, and participants. Details in the supplementary materials provide easy access to key regulatory documents and resources. Invited perspective articles provide greater depth from a systems, DEIA (diversity, equity, inclusion, and accessibility) and decentralized trials perspective.
Scientific discovery and clinical investigation are critical for developing and evaluating new treatments and can have substantial public health benefits. A detailed analysis of clinical trials funded by the National Institute of Neurological Disorders and Stroke found that the public return on investment in clinical trials has been substantial. In addition to the inherent risks involved in clinical trials, the challenges of translating scientific advances into new therapeutic advances are increasing. Many of the challenges of drug development are particularly acute for treatments of neurological conditions. The scope of clinical trials for neurological conditions is rapidly expanding to address orphan indications, biologics, medical devices, surgeries, and comparative effectiveness studies. In addition to drugs, clinical trials frequently evaluate devices for neurological conditions. High quality data on surgical interventions, such as temporal lobe resections for epilepsy are critical to understanding their relative risks and benefits in the target populations.
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