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The Food and Drug Administration and pragmatic clinical trials of marketed medical products.

Publication ,  Journal Article
Anderson, ML; Griffin, J; Goldkind, SF; Zeitler, EP; Wing, L; Al-Khatib, SM; Sherman, RE
Published in: Clin Trials
October 2015

Pragmatic clinical trials can help answer questions of comparative effectiveness for interventions routinely used in medical practice. Pragmatic clinical trials may examine outcomes of one or more marketed medical products, and they are heterogeneous in design and risk. The Food and Drug Administration is charged with protecting the rights, safety, and welfare of individuals enrolled in clinical investigations, as well as assuring the integrity of the data upon which approval of medical products is made. The Food and Drug Administration has broad jurisdiction over drugs and medical devices (whether or not they are approved for marketing), and as such, clinical investigations of these products are subject to applicable Food and Drug Administration regulations. While many pragmatic clinical trials will meet the criteria for an exemption from the requirements for an investigational new drug application or investigational device exemption, in general, all clinical investigations of medical products that fall under Food and Drug Administration jurisdiction must adhere to regulations for informed consent and review by an institutional review board. We are concerned that current Food and Drug Administration requirements for obtaining individual informed consent may deter or delay the conduct of pragmatic clinical trials intended to develop reliable evidence of comparative safety and effectiveness of approved medical products that are regulated by the Food and Drug Administration. Under current regulations, there are no described mechanisms to alter or waive informed consent to make it less burdensome or more practicable for low-risk pragmatic clinical trials. We recommend that the Food and Drug Administration establish a risk-based approach to obtaining informed consent in pragmatic clinical trials that would facilitate the conduct of pragmatic clinical trials without compromising the protection of enrolled individuals or the integrity of the resulting data.

Duke Scholars

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Published In

Clin Trials

DOI

EISSN

1740-7753

Publication Date

October 2015

Volume

12

Issue

5

Start / End Page

511 / 519

Location

England

Related Subject Headings

  • United States Food and Drug Administration
  • United States
  • Statistics & Probability
  • Patient Selection
  • Patient Safety
  • Investigational New Drug Application
  • Informed Consent
  • Humans
  • Drugs, Investigational
  • Clinical Trials as Topic
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Anderson, M. L., Griffin, J., Goldkind, S. F., Zeitler, E. P., Wing, L., Al-Khatib, S. M., & Sherman, R. E. (2015). The Food and Drug Administration and pragmatic clinical trials of marketed medical products. Clin Trials, 12(5), 511–519. https://doi.org/10.1177/1740774515597700
Anderson, Monique L., Joseph Griffin, Sara F. Goldkind, Emily P. Zeitler, Liz Wing, Sana M. Al-Khatib, and Rachel E. Sherman. “The Food and Drug Administration and pragmatic clinical trials of marketed medical products.Clin Trials 12, no. 5 (October 2015): 511–19. https://doi.org/10.1177/1740774515597700.
Anderson ML, Griffin J, Goldkind SF, Zeitler EP, Wing L, Al-Khatib SM, et al. The Food and Drug Administration and pragmatic clinical trials of marketed medical products. Clin Trials. 2015 Oct;12(5):511–9.
Anderson, Monique L., et al. “The Food and Drug Administration and pragmatic clinical trials of marketed medical products.Clin Trials, vol. 12, no. 5, Oct. 2015, pp. 511–19. Pubmed, doi:10.1177/1740774515597700.
Anderson ML, Griffin J, Goldkind SF, Zeitler EP, Wing L, Al-Khatib SM, Sherman RE. The Food and Drug Administration and pragmatic clinical trials of marketed medical products. Clin Trials. 2015 Oct;12(5):511–519.
Journal cover image

Published In

Clin Trials

DOI

EISSN

1740-7753

Publication Date

October 2015

Volume

12

Issue

5

Start / End Page

511 / 519

Location

England

Related Subject Headings

  • United States Food and Drug Administration
  • United States
  • Statistics & Probability
  • Patient Selection
  • Patient Safety
  • Investigational New Drug Application
  • Informed Consent
  • Humans
  • Drugs, Investigational
  • Clinical Trials as Topic