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Practical Guide to Budgeting and Funding a Clinical Trial in Surgery

To identify the key insights or developments described in this article
1 Credit CME

The conduct of clinical research is a resource-intensive endeavor typically funded by the federal government, philanthropies, or manufacturing industry. Trailists who seek funding must reliably estimate the cost to conduct the research (Box). Although budgets seem mundane, financial backing requires an accounting of how the funds will be used to accomplish the stated objectives. Grant applications must offer a sound scientific rationale for the research, ensure the ethical treatment of the participants, and construct a realistic budget that justifies the investment. Herein, we review considerations for preparing the budget.1 Key determinants to the size of the budget include sample size, the need to render nonroutine clinical care, the overall timeline of the proposed work, and the number of sites participating in a trial. As each of these grows, so grows the number of research personnel and the overall budget. This review enumerates the different types of available funding2 and summarizes the way to apply for such funds, using the United States as an example. The budget and funding request are central to the planning of a serious research endeavor.

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CME Disclosure Statement: Unless noted, all individuals in control of content reported no relevant financial relationships. If applicable, all relevant financial relationships have been mitigated.

Article Information

Corresponding Author: Eric L. Lazar, MD, MBA, MS, Department of Surgery, Morristown Medical Center, Atlantic Health System, 100 Madison Ave, Box 88, Morristown, NJ 07960 (eric.lazar@atlantichealth.org).

Published Online: October 26, 2022. doi:10.1001/jamasurg.2022.4907

Conflict of Interest Disclosures: None reported.

References
1.
Lazar  EL . Budgeting for a clinical trial. In: Itani  K , Reda  D , eds.  Clinical Trials Design in Operative and Non-Operative Invasive Procedures. Springer; 2017, doi:10.1007/978-3-319-53877-8_50.
2.
Lazar  EL . Funding a clinical trial. In: Itani  K , Reda  D , eds.  Clinical Trials Design in Operative and Non-Operative Invasive Procedures. Springer; 2017, doi:10.1007/978-3-319-53877-8_51.
3.
National Institutes of Health. Grants and funding: salary cap summary. Updated February 10, 2021. https://www.grants.nih.gov/grants/policy/salcap_summary.htm
4.
Agency for Healthcare Research and Quality. Funding & grants. Accessed September 21, 2022. https://www.ahrq.gov/funding/index.html
5.
US Department of Veterans Affairs. Office of Research & Development: funding. Accessed September 21, 2022. https://www.research.va.gov/funding/
6.
National Institutes of Health, National Center for Advancing Translational Sciences. Clinical and Translational Science Awards (CTSA) program. Updated August 4, 2022. https://ncats.nih.gov/ctsa/
7.
Patient-Centered Outcomes Research Institute (PCORI). Funding opportunities. Accessed September 21, 2022. https://pcori.org/funding-opportunities
AMA CME Accreditation Information

Credit Designation Statement: The American Medical Association designates this Journal-based CME activity activity for a maximum of 1.00  AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to:

  • 1.00 Medical Knowledge MOC points in the American Board of Internal Medicine's (ABIM) Maintenance of Certification (MOC) program;;
  • 1.00 Self-Assessment points in the American Board of Otolaryngology – Head and Neck Surgery’s (ABOHNS) Continuing Certification program;
  • 1.00 MOC points in the American Board of Pediatrics’ (ABP) Maintenance of Certification (MOC) program;
  • 1.00 Lifelong Learning points in the American Board of Pathology’s (ABPath) Continuing Certification program; and
  • 1.00 CME points in the American Board of Surgery’s (ABS) Continuing Certification program

It is the CME activity provider's responsibility to submit participant completion information to ACCME for the purpose of granting MOC credit.

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