Problems with ethical approval and how to fix them: lessons from three trials in rheumatoid arthritis

Clinical trials are subject to costly and onerous regulation that aims to ensure they are well designed, with risks to participants minimised wherever possible, and any serious outstanding risks communicated clearly to participants. We set out to assess how well current regulatory frameworks meet these aims, and the extent to which the relevant regulatory documentation can be accessed for independent scrutiny, using three recent trials of interventions for rheumatoid arthritis.

A recent study reported that over 10 000 people with rheumatoid arthritis have been randomised to control groups receiving ineffective treatment in trials of biological disease modifying antirheumatic drugs, risking “irreversible deterioration in condition.”1 We investigated the process of ethical approval, an­d the information given to patients, for two trials of ocrelizumab included in this study (STAGE2 and FEATURE3). We also reviewed documents for a homeopathy trial in rheumatoid arthritis because problems with ethical approval and informed consent in complementary and alternative medicine have been reported.4 Rheumatoid arthritis is a common disease for which many new therapies have been developed over the past two decades; it is therefore ideal for exploring these issues, which are relevant to clinical trials in all areas of medicine.