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Showing 1 - 3‘Unrealistic Optimism’ Poses Ethical Challenges, May Affect Informed Consent Process
Does a patient’s optimistic expectation of reaping a health benefit from participating in phase I and phase II oncology studies, even when he understands that these early trials are not designed to provide direct therapeutic benefit, compromise the informed consent process? And, does that...
Expert Point of View: Kevin P. Weinfurt, PhD
Our work suggests three specific recommendations for researchers and care providers who are discussing with patients the possibility of enrolling in a phase I clinical trial. First, we should always communicate the likelihood of benefit in terms of the number of participants expected to derive...
Patient Expectations of Benefit in Early-phase Trials: Ethics Issues in Informed Consent
It has been found that many patients in early-phase oncology trials believe their chance of benefit to be much higher than estimates derived from historical data.1-3 In a recently reported study in Journal of Clinical Oncology, Kevin P. Weinfurt, PhD, of Duke Clinical Research Institute, and...
