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In terms of methodological deficiencies in clinical trials, it is essential to distinguish between what is unavoidable and avoidable.
Fremont, CA: With the rise in population, correspondingly, the number of people living with cancer is on the rise. Drug regulators are ready to speed up the approvals of novel cancer therapies through mechanisms like accelerated approval pathways that are granted to drug development programs. According to a recent cross-sectional analysis published in the British Medical Journal by academics in the UK, US and Canada, the need for speed comes at a cost. And the study analyzed 39 randomized controlled trials which support new cancer drug approvals from the European Medicines Agency (EMA) between 2014 and 2016. This is a gold standard method for evaluating if a treatment works.
In the analysis, out of 39 trials, 19 of them had a high risk of bias. In terms of trial outcomes, the efficacy of a cancer drug could be measured by looking at its effect on overall survival, and it is regarded as the best way. But not many drugs in the sample were evaluated based on overall survival. Instead, they were assessed on the basis of less objective surrogate measures such as progression-free survival. It means that if the investigators are aware of the information about the type of treatments received by the patients, it could either knowingly or unknowingly influence the assessment of that outcome.
The other elements of trial design driving the risk of bias include Cochrane risk-of-bias tool compromising five domains such as randomization. There were cases where the trial was labelled as a randomized controlled trial. Also, at a few instances learnt from EMA reports, there were significant protocol deviations that could potentially influence the outcomes and magnitude of the benefit. Another issue will be the missing outcome data when patients withdrew their consent to continue taking part in the trial. For those clinicians who are considering treatment strategies, the lack of clarity around outcome data will create a confusing landscape for patients and them. However, blindly accepting the fact that overall survival is the best way to measure cancer drug outcomes is not advised as there are many alternative endpoints other than survival
Further, there should be a better way to communicate the findings of studies to patients and doctors and is possible with the creation of a database that can be accessed publicly. This allows the patients themselves can examine the risk of bias in the trials that support the regulatory approval of these drugs.
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