Informed Consent and Decision Making Among Participants in Novel-Design Phase I Oncology Trials.

ABSTRACT:

Background

Although phase I clinical trials are the gateway to progress in cancer therapies, this setting poses ethical challenges to ensure that patients provide consent free from misunderstandings of therapeutic intent or unrealistic expectations of benefit. The design of phase I oncology trials has evolved rapidly over time and today includes more targeted agents and combinations of experimental drugs with standard drugs, which may further complicate how patients understand phase I research participation.

Methods

We conducted semistructured interviews regarding motivations, decision making, and understanding of trial purpose nested within a phase I clinical trial of a novel PI3kinase inhibitor combined with a standard oral chemotherapy in 18 participants.

Results

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SUBMITTER: Reeder-Hayes KE 

PROVIDER: S-EPMC5640413 | biostudies-literature | 2017 Oct

REPOSITORIES: biostudies-literature