Clinical trials not always benign for patients who volunteer

The large number of patients with rheumatoid arthritis exposed to placebo or ineffective treatments in clinical trials poses an ethical dilemma for investigators and clinicians.

Rheumatologist Dr Sam Whittle, coauthor of a BMJ article calling for transparency around clinical trial design and ethics approvals, said his concern was for patients unduly deprived of effective treatment.

“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’,” the BMJ article said.

In their own analysis of the ethical processes surrounding two clinical trials of ocrelizumab and a third study of a homeopathic remedy, the authors found insufficient evidence that potential harms were minimised.

Dr Whittle told the limbic the ethics committee structure was overdue for reform when poorly designed trials were approved that could lead to structural damage, excess pain or functional impairment in patients with active disease.

“In rheumatology and in other clinical areas, placebo controlled trials continue where it would be preferable to conduct trials comparing active agents,” he said.

“What is the process in ethics committee deliberations that allows this to happen? People who participate in clinical trials are a precious but finite resource. We want to prioritise the important trials and ensure the right patient is in the right trial at the right time.”

He said there was also concern about how potential risks were communicated to participants.

“There is a subjective component to the way risks are presented. All risks are typically framed around potential risks of the active drug with no mention of the risks of placebo which we think is an oversight,” he said.

“Most patient information forms are also densely worded and legalistic which is not necessarily the best way.”

He said the entire process should be more transparent and democratic with all stakeholders including patients contributing to improve research quality.

 Dr Whittle is involved in the development of the Australia & New Zealand Musculoskeletal (ANZMUSC) Clinical Trials Network.

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