Site readiness practices for clinical trials – considerations for CTSA hubs

Viera, Laura; James, Laura; Shekhar, Anantha; Ioachimescu, Octavian C.; Buse, John B.

doi:10.1017/cts.2023.569

Cited by 5 publications

(3 citation statements)

References 5 publications

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Section: Discussionmentioning

confidence: 99%

“…A set of metrics should be identified to show progress over time as qualifications are being adopted. An accompanying perspective from the CTSA program provides suggestions of expanding and harmonizing trial site readiness processes relevant to health care systems [17]. Additionally, establishing site readiness practices across sites would represent a first step toward a more comprehensive system of widely accepted qualifications and credentialing.…”

Section: Discussionmentioning

confidence: 99%

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A framework for assessing clinical trial site readiness

Buse,

Austin,

Johnston

et al. 2023

J. Clin. Trans. Sci.

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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.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

A framework for assessing clinical trial site readiness

Buse,

Austin,

Johnston

et al. 2023

J. Clin. Trans. Sci.

Self Cite

View full text Add to dashboard Cite

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“…In addition, there may be opportunities to partner with academic institutions, private companies, or other organizations to expand engagement with potential trial participants. Clinical and Translational Science Award (CTSA) hubs [ 20 ] could provide support through their integrating special population cores. Finally, recruitment methods that are cost effective, such as social media platforms, can also be effective tools for reaching diverse communities.…”

Section: What Can You Do?mentioning

confidence: 99%

Diversity, equity, inclusion, and access are necessary for clinical trial site readiness

Carter-Edwards,

Hidalgo,

Lewis-Hall

et al. 2023

J. Clin. Trans. Sci.

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Clinical research has long struggled with diversity, equity, inclusion, and access (DEIA). Despite the increasing diversity of the U.S. population, marginalized groups continue to be underrepresented in clinical trials. The lack of representation in clinical trials has impeded innovation, compromised generalizability of evidence, and may undermine trust in the clinical trials enterprise [1]conclusions that FDA echoes in its guidance on diversity plans [2]. DEIA must inform clinical trials from design to dissemination to generate valid, generalizable evidence that meets the needs of an increasingly diverse population and addresses health inequities.In this commentary, we discuss select site readiness practices, outlined in a companion article [3], which are particularly relevant to promoting DEIA in clinical trials. This perspective focuses on race and ethnicity, though other aspects of diversity, such as ability, sex, gender, sexual orientation, and others, also are underrepresented in clinical research [1,4]. Addressing race and ethnicity is an opportunity to intentionally focus efforts on a long-standing area of exclusion in clinical trials. The companion article includes the full set of site readiness practices, methods for their selection, and a rationale for their use by clinical trial sites. Site readiness practices must include DEIA considerations to avoid perpetuating existing inequities and to help address known or suspected barriers to clinical trials accesssuch as language, transportation, or dependent care [5]. Additionally, site readiness practices should seek to address structural constructs perpetuated within the medical and clinical trial enterprise that impede progress on these issuesthrough insurance coverage, hiring practices, partnership with communities, and mentorship opportunities. To this point, improving DEIA should specifically and explicitly be expressed as both goals and metrics for progress. Effective DEIA efforts in research participation should begin early, during the design and budgeting stages. Site readiness often involves actions taken even before the project's conceptualization, such as modifying existing systems or policies. We believe that the site readiness practices discussed in this article (Table 1) support the development of a clinical research system that is intentionally inclusive, and therefore more closely aligned with the needs of patients.

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