Incentives and payments in pragmatic clinical trials: Scientific, ethical, and policy considerations.

Journal Article (Journal Article)

Pragmatic clinical trials are increasingly used to generate knowledge about real-world clinical interventions. However, they involve some distinctive ethical and regulatory challenges. In this article, we examine a set of issues related to incentives and other payments to patients in pragmatic clinical trials. Although many of the ethical concerns related to incentives and payments in explanatory trials pertain to pragmatic clinical trials, the pragmatic features may introduce additional challenges. These include those related to the risk of incentives and payments undermining the scientific validity and social value of pragmatic clinical trials, the sources of data used in pragmatic clinical trials, and when the pragmatic clinical trials are conducted under waivers of consent. Based on our examination of these matters, we offer some preliminary recommendations regarding incentives and payments in pragmatic clinical trials, recognizing that additional data and experiences are needed to refine them.

Full Text

Duke Authors

Cited Authors

  • Garland, A; Weinfurt, K; Sugarman, J

Published Date

  • December 2021

Published In

Volume / Issue

  • 18 / 6

Start / End Page

  • 699 - 705

PubMed ID

  • 34766524

Pubmed Central ID

  • PMC8597901

Electronic International Standard Serial Number (EISSN)

  • 1740-7753

Digital Object Identifier (DOI)

  • 10.1177/17407745211048178

Language

  • eng

Conference Location

  • England