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

Pulford DJ1, Harter P2, Floquet A3, Barrett C4, Suh DH5, Friedlander M6, Arranz JA7, Hasegawa K8, Tada H9,10, Vuylsteke P11, Mirza MR12, Donadello N13, Scambia G14, Johnson T15, Cox C15, Chan JK16, Imhof M17, Herzog TJ18, Calvert P19, Wimberger P20, Berton-Rigaud D21, Lim MC22, Elser G23, Xu CF15, du Bois A2.

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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).