There’s an interesting comment piece by Professor Mary Dixon-Woods in the Lancet Oncology this week. The ‘Research Ethics Committee’ approval, which is required before a clinical trial can begin, has been criticised by some doctors as being too slow, too burdensome, and inconsistent. The concern has been that the process of gaining ethical approval for a study is, amongst other things, so bureaucratic that important questions about treatments are not being asked, because it is too hard to get permission to do so. This comment piece looks at the reasons why Research Ethics Committees decide not to approve trials. The major reason, the authors found, was to do with informed consent. In some cases, the REC was concerned that the trial was couched in overly enthusiastic terms, eg a patient information sheets said ‘we hope that participation in the trial will help you by providing the best available treatment for your cancer’.
This is especially interesting, particularly given the recent coverage of the prostate cancer drug abiraterone (see blog post below.) So far, there is one published clinical trial; a study of just 21 men. How are patients going to feel about entering into a trial where they may not get this (overly hyped) drug?