COVID-19 News

VA Lessons From Partnering in COVID-19 Clinical Trials

Fed Pract. 2023 November;40(5):S18 | doi:10.12788/fp.0415

References

2. Garcia AP, Huang GD, Arnheim L, Ramoni R, Clancy C. The VA research enterprise: a platform for national partnerships toward evidence building and scientific innovation. Fed Pract. 2023;40(suppl 5):S12-S17. doi:10.12788/fp.0425

3. Johnston SC, Lewis-Hall F, Bajpai A, et al. It’s time to harmonize clinical trial site standards. NAM Perspectives. October 9, 2017. Accessed August 28, 2023. https://nam.edu/wp-content/uploads/2017/10/Its-Time-to-Harmonize-Clinical-Trial-Site-1.pdf

4. Condon DL, Beck D, Kenworthy-Heinige T, et al. A cross-cutting approach to enhancing clinical trial site success: the Department of Veterans Affairs’ Network of Dedicated Enrollment Sites (NODES) model. Contemp Clin Trials Commun. 2017;6:78-84. Published 2017 Mar 29. doi:10.1016/j.conctc.2017.03.006

5. US Food and Drug Administration. Master protocols: efficient clinical trial design strategies to expedite development of oncology drugs and biologics guidance for industry. March 2022. Accessed August 23, 2023. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/master-protocols-efficient-clinical-trial-design-strategies-expedite-development-oncology-drugs-and

6. IOM Roundtable on Value & Science-Driven Care; Institute of Medicine. Continuous learning and improvement in health care. In: Integrating Research and Practice: Health System Leaders Working Toward High-Value Care: Workshop Summary. National Academies Press (US); 2015:chap 2. Accessed August 28, 2023. https://www.ncbi.nlm.nih.gov/books/NBK284654 7. Institute of Medicine (US). Building an infrastructure to support clinical trials. In: Envisioning a Transformed Clinical Trials Enterprise in the United States. National Academies Press (US); 2012:chap 5. Accessed August 28, 2023. https://www.ncbi.nlm.nih.gov/books/NBK114656

8. Park JJH, Harari O, Dron L, Lester RT, Thorlund K, Mills EJ. An overview of platform trials with a checklist for clinical readers. J Clin Epidemiol. 2020;125:1-8. doi:10.1016/j.jclinepi.2020.04.025

9. Meeker-O’Connell A, Glessner C, Behm M, et al. Enhancing clinical evidence by proactively building quality into clinical trials. Clin Trials. 2016;13(4):439-444. doi:10.1177/1740774516643491

10. McClure J, Asghar A, Krajec A, et al. Clinical trial facilitators: a novel approach to support the execution of clinical research at the study site level. Contemp Clin Trials Commun. 2023;33:101106. doi:10.1016/j.conctc.2023.101106

Internal and External Communication

The value of communication—both internal and external—cannot be understated. Minimizing confusion, managing expectations, and ensuring consistent messaging were essential for rapid trial execution. Despite being the second largest federal agency, the VA did not have a seat at the study leadership table for several protocols. When it joined later, several study aspects were set and/or difficult to revise. Challenges affecting time and securing resources have been noted. The ability to plan and then share expectations and responsibilities across and within the respective participating organizations early in the process was perhaps the single factor that was most addressable. The VA enterprise organization and integration with other units could accentuate key communications that would be essential in time-sensitive activities.

VA as a Partner for Future Research

Before the pandemic, the VA had already undertaken a path to enhance its ability to partner as part of the national biomedical research enterprise. The need for COVID-19 therapeutic and vaccine trials accelerated opportunities to plan and develop processes and capabilities to advance this path. As a key strength for VA scientific activities, clinical trials represent a primary medium by which to develop its partnerships. Learning and development have become part of a culture that expedites opportunities for veterans who actively seek ways to contribute to medical knowledge and treatments for their peers and the nation.

CONCLUSIONS

Challenges associated with rapid startup and completion of clinical trials have been discussed for some time. During the pandemic, needs and barriers were magnified because of the heightened urgency for evidence-based therapeutics and vaccines. While the VA faced similar problems as well as those specific to it as a health care system, it had the opportunity to learn and more systematically implement solutions to help in its partnered efforts.¹⁰ As an enterprise, the VA hopes to apply lessons learned, strategies, and best practices to further its goals to enhance veteran access to clinical trials and respond to any future need to quickly establish evidence bases in pandemics and other health emergencies that warrant the rapid implementation of research.

Acknowledgments

The activities reported here were supported by the US Department of Veterans Affairs, Office of Research and Development.

References

1. Hays MT; US Department of Veterans Affairs, Veterans Health Administration, Office of Research and Development. A historical look at the establishment of the Department of Veterans Affairs Research & Development Program. Accessed August 28, 2023. https://www.research.va.gov/pubs/docs/ORD-85yrHistory.pdf

2. Garcia AP, Huang GD, Arnheim L, Ramoni R, Clancy C. The VA research enterprise: a platform for national partnerships toward evidence building and scientific innovation. Fed Pract. 2023;40(suppl 5):S12-S17. doi:10.12788/fp.0425

3. Johnston SC, Lewis-Hall F, Bajpai A, et al. It’s time to harmonize clinical trial site standards. NAM Perspectives. October 9, 2017. Accessed August 28, 2023. https://nam.edu/wp-content/uploads/2017/10/Its-Time-to-Harmonize-Clinical-Trial-Site-1.pdf

4. Condon DL, Beck D, Kenworthy-Heinige T, et al. A cross-cutting approach to enhancing clinical trial site success: the Department of Veterans Affairs’ Network of Dedicated Enrollment Sites (NODES) model. Contemp Clin Trials Commun. 2017;6:78-84. Published 2017 Mar 29. doi:10.1016/j.conctc.2017.03.006

5. US Food and Drug Administration. Master protocols: efficient clinical trial design strategies to expedite development of oncology drugs and biologics guidance for industry. March 2022. Accessed August 23, 2023. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/master-protocols-efficient-clinical-trial-design-strategies-expedite-development-oncology-drugs-and

6. IOM Roundtable on Value & Science-Driven Care; Institute of Medicine. Continuous learning and improvement in health care. In: Integrating Research and Practice: Health System Leaders Working Toward High-Value Care: Workshop Summary. National Academies Press (US); 2015:chap 2. Accessed August 28, 2023. https://www.ncbi.nlm.nih.gov/books/NBK284654 7. Institute of Medicine (US). Building an infrastructure to support clinical trials. In: Envisioning a Transformed Clinical Trials Enterprise in the United States. National Academies Press (US); 2012:chap 5. Accessed August 28, 2023. https://www.ncbi.nlm.nih.gov/books/NBK114656

8. Park JJH, Harari O, Dron L, Lester RT, Thorlund K, Mills EJ. An overview of platform trials with a checklist for clinical readers. J Clin Epidemiol. 2020;125:1-8. doi:10.1016/j.jclinepi.2020.04.025

9. Meeker-O’Connell A, Glessner C, Behm M, et al. Enhancing clinical evidence by proactively building quality into clinical trials. Clin Trials. 2016;13(4):439-444. doi:10.1177/1740774516643491

10. McClure J, Asghar A, Krajec A, et al. Clinical trial facilitators: a novel approach to support the execution of clinical research at the study site level. Contemp Clin Trials Commun. 2023;33:101106. doi:10.1016/j.conctc.2023.101106

The VA Research Enterprise: A Platform for National Partnerships Toward Evidence Building and Scientific Innovation

VA Lessons From Partnering in COVID-19 Clinical Trials

References

Internal and External Communication

VA as a Partner for Future Research

CONCLUSIONS

Acknowledgments

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