Informed consent: meet patients' needs

摘要

We agree that informed-consent forms should be improved (Nature 482,16; 2012) beyond shortening and simplifying them. Participants need to know whether a trial is addressing an unmet clinical need, and that the test is necessary to answer a key question.For example, a 'me-too' drug that seeks marketing authorization by comparison against a placebo, rather than against alternative products, will not solve a patient's unmet need.