Clinical Trial Portfolios: A Critical Oversight in Human Research Ethics, Drug Regulation, and Policy

Hastings Center Report 49 (4):31-41 (2019)
  Copy   BIBTEX

Abstract

Regulators rely on clinical trials for drug approval and labeling decisions. Health systems and clinicians rely on the evidence from trials to determine treatment, and patients rely on it to decide which courses of care to undertake. Many of these stakeholders presume that the careful review of individual studies is enough to address the ethical and scientific questions that arise in clinical trials. In what follows, however, we demonstrate that explicit consideration of trial portfolios—series of trials that are interrelated by a common set of objectives—is crucial. the ethical acceptability and evidentiary probity of individual trials can change depending on the characteristics of the portfolios in which they are embedded. Second, how trial portfolios are composed, how well they are coordinated, and how efficiently they use information determines the balance of risks and benefits they present as well as their different prospects for generating socially valuable information; these three factors also raise distinct questions of justice.

Links

PhilArchive



    Upload a copy of this work     Papers currently archived: 93,745

External links

Setup an account with your affiliations in order to access resources via your University's proxy server

Through your library

Similar books and articles

Analytics

Added to PP
2019-08-21

Downloads
30 (#132,620)

6 months
6 (#1,472,471)

Historical graph of downloads
How can I increase my downloads?

Author's Profile

Alex John London
Carnegie Mellon University