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
. 2015 Sep 19:21:2794-800.
doi: 10.12659/MSM.894327.

Perspectives on a Multidisciplinary Team Approach to Implementation of Planned Emergent Use Research

Affiliations

Perspectives on a Multidisciplinary Team Approach to Implementation of Planned Emergent Use Research

Carlos J Racedo Africano et al. Med Sci Monit. .

Abstract

In this paper we present the viewpoints of three members of a research team, on the approach to teamwork in the development of an emergent use clinical trial when dealing with diversity of opinions, in order to facilitate stakeholder buy-in. We also discuss a specific approach to the coordination of the team members, which in our opinion had a positive impact on the implementation of the project. We also comment on the influence of the team organization in the timeline and completion of a clinical trial. We hope to start a conversation on team dynamics in the design of clinical trials, especially in the context of emergent use research.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Organizational flow chart of study sections and tasks within each section.

Similar articles

Cited by

  • Clinical trials.
    Polidori P, Makridaki D, Kohl S; delegates of the 52nd EAHP General Assembly. Polidori P, et al. Eur J Hosp Pharm. 2024 Feb 22;31(2):162-164. doi: 10.1136/ejhpharm-2022-003471. Eur J Hosp Pharm. 2024. PMID: 36931719 Free PMC article. No abstract available.

References

    1. Hoffman A, Montgomery R, Aubry W, Tunis SR. How best to engage patients, doctors, and other stakeholders in designing comparative effectiveness studies. Health Aff. 2010;29(10):1834–41. - PubMed
    1. US Department of Health and Human Services, editor. Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors Exception from Informed Consent Requirements for Emergency Research, F.a.D.A. Silver Spring, MD: 2011. updated 2013.
    1. Smischney NJ, Onigkeit JA, Hinds RF, Nicholson WT. Re-evaluating ethical concerns in planned emergency research involving critically ill patients: an interpretation of the guidance document from the United States food and drug administration. J Clin Ethics. 2015;26(1):61–67. - PubMed
    1. Gawande A. The checklist manifesto: How to get things right. 1st ed. New York: Metropolitan Books; 2010. p. 209.
    1. Pronovost P, Needham D, Berenholtz S, et al. An intervention to decrease catheter-related bloodstream infections in the ICU. N Engl J Med. 2006;355(26):2725–32. - PubMed

MeSH terms