Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2023 May 8;7(1):e151.
doi: 10.1017/cts.2023.541. eCollection 2023.

A framework for assessing clinical trial site readiness

John B Buse  1 , Christopher P Austin  2 , S Claiborne Johnston  3 , Freda Lewis-Hall  4 , Andrew N March  5 , Carolyn K Shore  5 , Pamela Tenaerts  6 , Joni L Rutter  7
Affiliations

A framework for assessing clinical trial site readiness

John B Buse et al. J Clin Transl Sci. .

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.

Keywords: Clinical trial sites; adoption and implementation; evaluation; quality improvement; site readiness practices.

PubMed Disclaimer

Conflict of interest statement

JBB has contracted consulting fees and travel support for contracted activities paid to the University of North Carolina by Novo Nordisk; grant support paid to the University of North Carolina by Dexcom, NovaTarg, Novo Nordisk, Sanofi, Tolerion and vTv Therapeutics; payments for consultation from Alkahest, Altimmune, Anji, AstraZeneca, Bayer, Biomea Fusion Inc., Boehringer-Ingelheim, CeQur, Cirius Therapeutics Inc., Dasman Diabetes Center (Kuwait), Eli Lilly, Fortress Biotech, GentiBio, Glycadia, Glyscend, Janssen, MannKind, Mediflix, Medscape, Mellitus Health, Moderna, Pendulum Therapeutics, Praetego, ReachMD, Sanofi, Stability Health, Valo, Zealand Pharma; stock/options in Glyscend, Mellitus Health, Pendulum Therapeutics, PhaseBio, Praetego, and Stability Health.

Figures

Figure 1.
Figure 1.
Common principles and domains for site readiness practices for clinical trial site readiness.
See this image and copyright information in PMC

References

    1. The Pharmaceutical Research & Manufacturers of America, Improving clinical trial diversity is critical to health equity, https://phrma.org/Equity/clinical-trial-diversity, Accessed October 28, 2022.
    1. Schneeman K, Sud A. Building community-based infrastructure for inclusive research: lessons from the pandemic for federal action. FasterCures, a Center of the Milken Institute, https://milkeninstitute.org/sites/default/files/2022-05/Building%20Commu..., Accessed October 28, 2022.
    1. National Academies of Sciences, Engineering, and Medicine. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop, The National Academies Press, 2022:138. - PubMed
    1. Vose JM, Levit LA, Hurley P, et al. Addressing administrative and regulatory burden in cancer clinical trials: summary of a stakeholder survey and workshop hosted by the American Society of Clinical Oncology and the Association of American Cancer Institutes. J Clin Oncol. 2016;34(v 1):3796–3802. doi: 10.1200/jco.2016.69.6781. - DOI - PubMed
    1. Woodcock J, Araojo R, Thompson T, Puckrein GA. Integrating research into community practice — toward increased diversity in clinical trials. N Engl J Med. 2021;385(15):1351–1353. doi: 10.1056/NEJMp2107331. - DOI - PubMed

LinkOut - more resources