A framework for assessing clinical trial site readiness

Abstract

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.

Successful transport across continents of GMP-manufactured and cryopreserved culture-expanded human fetal liver-derived mesenchymal stem cells for use in a clinical trial

“…We began by identifying the areas that require special attention in order to achieve the goal of a well characterized cell therapy product with retained quality when administered to the patient [ 6 , 9 ]. Thus, a site assessment of the receiving site was performed to confirm that the conditions in terms of staff, facilities, equipment, storage and handling was in place [ 12 , 23 ]. Thereafter we transferred knowledge, protocols and methods for the thawing, reconstitution and quality control of the cells to the clinical site [ [24] , [25] , [26] ].…”

Scientia pro bono humani generis: Science for the benefit of humanity

“…Their effort is to develop a framework for clinical trial site readiness based on existing trial site qualifications from industry sponsors across six domains: research team, infrastructure, study management, data collection and management, quality oversight, and ethics and safety. Implementation of the framework is expected to reduce inefficiencies, serve as guidance to new sites wishing to enter the clinical trial enterprise, and increase engagement with underrepresented communities [ 6 ]. Institutional infrastructure investments, such as the adoption and implementation of a robust clinical trial management system, can provide an approach to monitor enterprise-wide metrics for clinical trial operations, enabling the identification of factors within the institution that contribute to inefficiencies.…”

Site readiness practices for clinical trials – considerations for CTSA hubs

“…Industry, federal, and foundation sponsors consider these factors in their assessment of site readiness when selecting sites to execute clinical trial protocols. While site selection factors vary somewhat depending on sponsor and trial type, "A Framework for Assessing for Clinical Trial Site Readiness" has identified a core set of site readiness practices that are recommended for all sites interested in initiating and executing clinical trials [5]. The site readiness practices include factors spanning domains of research team, infrastructure, study management, data collection and management, quality oversight, and ethics and safety (Table 1).…”