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Developing and Implementing Performance Outcome Assessments: Evidentiary, Methodologic, and Operational Considerations.

Publication ,  Journal Article
Richardson, E; Burnell, J; Adams, HR; Bohannon, RW; Bush, EN; Campbell, M; Chen, WH; Coons, SJ; Papadopoulos, E; Reeve, BR; Rooks, D; Daniel, G
Published in: Ther Innov Regul Sci
January 2019

The use of performance outcome (PerfO) assessments to measure cognitive or physical function in drug trials presents several challenges for both sponsors and regulators, owing in part to a relative lack of scientific guidance on their development, implementation, and interpretation. In December 2016, the Duke-Margolis Center for Health Policy convened a 2-day workshop to explore the evidentiary, methodologic, and operational challenges associated with PerfO measures, and to identify potential paths to addressing these challenges. This paper presents both a summary of the discussion as well as additional input from a working group of experts from FDA, industry, academia, and public-private consortia. It is intended to advance the discussion around the development and use of PerfO measures to assess patient functioning in clinical trials intended to support registration of new treatments, and to highlight the key gaps in knowledge where additional research, collaboration, and discussion are needed.

Duke Scholars

Published In

Ther Innov Regul Sci

DOI

EISSN

2168-4804

Publication Date

January 2019

Volume

53

Issue

1

Start / End Page

146 / 153

Location

Switzerland

Related Subject Headings

  • Outcome Assessment, Health Care
  • Humans
  • Clinical Trials as Topic
 

Citation

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Chicago
ICMJE
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Richardson, E., Burnell, J., Adams, H. R., Bohannon, R. W., Bush, E. N., Campbell, M., … Daniel, G. (2019). Developing and Implementing Performance Outcome Assessments: Evidentiary, Methodologic, and Operational Considerations. Ther Innov Regul Sci, 53(1), 146–153. https://doi.org/10.1177/2168479018772569
Richardson, Elizabeth, Jessica Burnell, Heather R. Adams, Richard W. Bohannon, Elizabeth Nicole Bush, Michelle Campbell, Wen Hung Chen, et al. “Developing and Implementing Performance Outcome Assessments: Evidentiary, Methodologic, and Operational Considerations.Ther Innov Regul Sci 53, no. 1 (January 2019): 146–53. https://doi.org/10.1177/2168479018772569.
Richardson E, Burnell J, Adams HR, Bohannon RW, Bush EN, Campbell M, et al. Developing and Implementing Performance Outcome Assessments: Evidentiary, Methodologic, and Operational Considerations. Ther Innov Regul Sci. 2019 Jan;53(1):146–53.
Richardson, Elizabeth, et al. “Developing and Implementing Performance Outcome Assessments: Evidentiary, Methodologic, and Operational Considerations.Ther Innov Regul Sci, vol. 53, no. 1, Jan. 2019, pp. 146–53. Pubmed, doi:10.1177/2168479018772569.
Richardson E, Burnell J, Adams HR, Bohannon RW, Bush EN, Campbell M, Chen WH, Coons SJ, Papadopoulos E, Reeve BR, Rooks D, Daniel G. Developing and Implementing Performance Outcome Assessments: Evidentiary, Methodologic, and Operational Considerations. Ther Innov Regul Sci. 2019 Jan;53(1):146–153.
Journal cover image

Published In

Ther Innov Regul Sci

DOI

EISSN

2168-4804

Publication Date

January 2019

Volume

53

Issue

1

Start / End Page

146 / 153

Location

Switzerland

Related Subject Headings

  • Outcome Assessment, Health Care
  • Humans
  • Clinical Trials as Topic