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Good Clinical Practice Guidance and Pragmatic Clinical Trials: Balancing the Best of Both Worlds.

Publication ,  Journal Article
Mentz, RJ; Hernandez, AF; Berdan, LG; Rorick, T; O'Brien, EC; Ibarra, JC; Curtis, LH; Peterson, ED
Published in: Circulation
March 1, 2016

Randomized, clinical trials are commonly regarded as the highest level of evidence to support clinical decisions. Good Clinical Practice guidelines have been constructed to provide an ethical and scientific quality standard for trials that involve human subjects in a manner aligned with the Declaration of Helsinki. Originally designed to provide a unified standard of trial data to support submission to regulatory authorities, the principles may also be applied to other studies of human subjects. Although the application of Good Clinical Practice principles generally led to improvements in the quality and consistency of trial operations, these principles have also contributed to increasing trial complexity and costs. Alternatively, the growing availability of electronic health record data has facilitated the possibility for streamlined pragmatic clinical trials. The central tenets of Good Clinical Practice and pragmatic clinical trials represent potential tensions in trial design (stringent quality and highly efficient operations). In the present article, we highlight potential areas of discordance between Good Clinical Practice guidelines and the principles of pragmatic clinical trials and suggest strategies to streamline study conduct in an ethical manner to optimally perform clinical trials in the electronic age.

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Published In

Circulation

DOI

EISSN

1524-4539

Publication Date

March 1, 2016

Volume

133

Issue

9

Start / End Page

872 / 880

Location

United States

Related Subject Headings

  • Research Design
  • Practice Guidelines as Topic
  • Humans
  • Clinical Trials as Topic
  • Cardiovascular System & Hematology
  • 4207 Sports science and exercise
  • 3202 Clinical sciences
  • 3201 Cardiovascular medicine and haematology
  • 1117 Public Health and Health Services
  • 1103 Clinical Sciences
 

Citation

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Chicago
ICMJE
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Mentz, R. J., Hernandez, A. F., Berdan, L. G., Rorick, T., O’Brien, E. C., Ibarra, J. C., … Peterson, E. D. (2016). Good Clinical Practice Guidance and Pragmatic Clinical Trials: Balancing the Best of Both Worlds. Circulation, 133(9), 872–880. https://doi.org/10.1161/CIRCULATIONAHA.115.019902
Mentz, Robert J., Adrian F. Hernandez, Lisa G. Berdan, Tyrus Rorick, Emily C. O’Brien, Jenny C. Ibarra, Lesley H. Curtis, and Eric D. Peterson. “Good Clinical Practice Guidance and Pragmatic Clinical Trials: Balancing the Best of Both Worlds.Circulation 133, no. 9 (March 1, 2016): 872–80. https://doi.org/10.1161/CIRCULATIONAHA.115.019902.
Mentz RJ, Hernandez AF, Berdan LG, Rorick T, O’Brien EC, Ibarra JC, et al. Good Clinical Practice Guidance and Pragmatic Clinical Trials: Balancing the Best of Both Worlds. Circulation. 2016 Mar 1;133(9):872–80.
Mentz, Robert J., et al. “Good Clinical Practice Guidance and Pragmatic Clinical Trials: Balancing the Best of Both Worlds.Circulation, vol. 133, no. 9, Mar. 2016, pp. 872–80. Pubmed, doi:10.1161/CIRCULATIONAHA.115.019902.
Mentz RJ, Hernandez AF, Berdan LG, Rorick T, O’Brien EC, Ibarra JC, Curtis LH, Peterson ED. Good Clinical Practice Guidance and Pragmatic Clinical Trials: Balancing the Best of Both Worlds. Circulation. 2016 Mar 1;133(9):872–880.

Published In

Circulation

DOI

EISSN

1524-4539

Publication Date

March 1, 2016

Volume

133

Issue

9

Start / End Page

872 / 880

Location

United States

Related Subject Headings

  • Research Design
  • Practice Guidelines as Topic
  • Humans
  • Clinical Trials as Topic
  • Cardiovascular System & Hematology
  • 4207 Sports science and exercise
  • 3202 Clinical sciences
  • 3201 Cardiovascular medicine and haematology
  • 1117 Public Health and Health Services
  • 1103 Clinical Sciences