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Methodology

  • Arthur L. Caplan
  • Barbara K. Redman
Chapter

Abstract

Research integrity is now being redefined to require a higher level of methodological quality than has historically been the case. Innovations to reach this new standard fall into several categories: increased use of alternative trial designs with questions about how subject protection can be applied; need to move away from ‘P’ values and toward effect sizes in statistical analysis and full reporting of research methods including methods of analysis and modified endpoints. Driven by the recognition that the historically dominant standard of the randomized placebo-controlled trial (RCT) is not economically, politically, or scientifically always useful, new trial designs recognize the heterogeneity of disease, the need for timely answers in humanitarian emergencies or for the seriously ill, improvement in trial recruitment and receipt of appropriate treatment, and recognition of the need to synthesize information across trials.

Keywords

Scientific quality Trial design Reporting requirements 

References

  1. Berry D. Emerging innovations in clinical trial design. Clin Pharmacol Ther. 2016;99(1):82–91.CrossRefPubMedGoogle Scholar
  2. Grinnell F. Research integrity and everyday practice of science. Sci Eng Ethics. 2013;19(3):193–9.CrossRefGoogle Scholar

Additional Suggested Reading

  1. Berry D. Emerging innovations in clinical trial design. Clin Pharmacol Ther. 2016;99(1):82–91. (Provides a review of emerging clinical trial designs driven by increasing recognition that diseases and patients are heterogeneous.)CrossRefPubMedGoogle Scholar
  2. Grinnell F. Research integrity and everyday practice of science. Sci Eng Ethics. 2013;19(3):685–701. (Notes that “science is traditionally taught as a linear process based on logic and carried out by objective researchers following the scientific method” is not accurate. Research integrity should be taught as it is carried out in the everyday practice of science.) CrossRefPubMedGoogle Scholar
  3. Weintraub W, Luscher T, Pocock S. The perils of surrogate endpoints. Eur Heart J. 2015;36(33):2212–8. (Describes the difficult but necessary steps in validating surrogate endpoints.)CrossRefPubMedPubMedCentralGoogle Scholar

Copyright information

© Springer International Publishing AG, part of Springer Nature 2018

Authors and Affiliations

  • Arthur L. Caplan
    • 1
  • Barbara K. Redman
    • 1
  1. 1.New York University Langone Medical CenterNew YorkUSA

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