Riociguat for Pulmonary Hypertension REPLY

To the Editor: Reith et al. (Sept. 12 issue)(1) suggest that clinical trials comparing widely accepted therapies should not be held to the excessively detailed informed consent standards of trials involving new therapies. Their justification appears to be as follows: for treatment purposes, patients already accept the risks of well-understood therapies for which evaluative data are sparse, so why should clinicians and researchers need to adhere to more stringent consent standards when providing those same therapies in a research context? Clinical research is designed to narrow the scope of clinical uncertainty by identifying unknown risks and benefits and determining which ...