Considering entering a clinical trial? Do your homework, breast cancer consumer representative says

People considering entering a clinical trial should not be put off from all studies by some with financial ties between researchers and pharmaceutical companies, a long-time trial advisor says.

For more than 20 years, Linda Reaby has sat as a ‘citizen representative’ on the Australia and New Zealand Breast Cancer Trials Group and in more recent years advised the International Breast Cancer Intervention Study.

Clinical trials are used to investigate the safety of new medicines and medical devices and assess such products “efficacy” – or to what extent they actually work – before seeking government approval to put a medicine on the market.

It can cost a company hundreds of millions of dollars to conduct a rigorous trial, but the pay-offs can be in the billions and recent research has indicated links between financial ties between pharmaceutical companies, researchers and the “positive” outcomes of clinical trials.

But Ms Reaby said such links could also be due to companies funding trials for “more promising drugs”, while those less-promising drugs which would yield more “negative” results may not proceed to a full trial.

Ms Reaby said while there were some studies that weren’t up to scratch on conflicts of interest, academic independence and data integrity, most of those conducted in Australia were subject to strict oversight.

“But the corruption of other studies taints the efforts of unbiased researchers seeking medical advancements,” she said.

She said people considering entering a clinical trial were often not making decisions based on the best evidence available, as their judgement could be clouded by the uncertainty surrounding their diagnosis.

“People are not often thinking about the evidence, their thinking is often clouded by the disease, so it’s important to have someone there (you trust) to ask the tough questions and work with you,” she said.

Ms Reaby, who has suffered breast cancer and has participated in a clinical trial, also recommended people ask their GP if they can record appointments, so they can go back to the recording to ask questions they forget to ask during appointments.

She said there were also several things for people to look out for when considering entering a clinical trial including an independent, ethical, committee overseeing the trial, with a majority of “non-industry” people on such committees.

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