Communicating BRCA research results to patients enrolled in international clinical trials: Lessons learnt from the AGO-OVAR 16 study

Giovanni Scambia, David J. Pulford, Philipp Harter, Anne Floquet, Catherine Barrett, Dong Hoon Suh, Michael Friedlander, José Angel Arranz, Kosei Hasegawa, Hiroomi Tada, Peter Vuylsteke, Mansoor R. Mirza, Nicoletta Donadello, Toby Johnson, Charles Cox, John K. Chan, Martin Imhof, Thomas J. Herzog, Paula Calvert, Pauline WimbergerDominique Berton-Rigaud, Myong Cheol Lim, Gabriele Elser, Chun-Fang Xu, Andreas Du Bois

Risultato della ricerca: Contributo in rivistaArticolo in rivista

1 Citazioni (Scopus)

Abstract

Background: The focus on translational research in clinical trials has the potential to generate clinically relevant genetic data that could have importance to patients. This raises challenging questions about communicating relevant genetic research results to individual patients. Methods: An exploratory pharmacogenetic analysis was conducted in the international ovarian cancer phase III trial, AGO-OVAR 16, which found that patients with clinically important germ-line BRCA1/2 mutations had improved progression-free survival prognosis. Mechanisms to communicate BRCA results were evaluated, because these findings may be beneficial to patients and their families. Results: Communicating individual BRCA results was not anticipated during clinical trial design. Consequently, options were not available for patients to indicate their preference for receiving their individual results when they signed pharmacogenetic informed consent. Differences in local requirements, clinical practice, and opinion regarding the ethical aspects of how to convey genetic results to patients are all potential barriers to returning individual BRCA results to patients. Communicating the aggregate BRCA result from this study provided clinical investigators with a mechanism to disseminate the overall study finding to patients while taking individual circumstances, local guidelines and clinical practice into account. Conclusion: This study illustrates the importance of increasing the clarity and scope of informed consent and the need for patient engagement to ensure clinical trial participants can indicate their preference regarding receipt of potentially important individual pharmacogenetic results. Trial registration: This study was registered in the NCT Clinical Trial Registry under NCT00866697 on March 19, 2009, following approval from participating ethics committees (Additional file 1).
Lingua originaleEnglish
pagine (da-a)1-11
Numero di pagine11
RivistaBMC Medical Ethics
Volume17
DOI
Stato di pubblicazionePubblicato - 2016

Keywords

  • BRCA mutation
  • Bioethics
  • Health (social science)
  • Health Policy
  • Incidental finding
  • Issues, Ethics and Legal Aspects
  • Ovarian cancer
  • Pharmacogenetic research

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