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Biased by design? Clinical trials and patient benefit in oncology

Biased by design? Clinical trials and patient benefit in oncology

A discussion on the design characteristics and the risk of bias of clinical trials in oncology by Pan Pantziarka, Ciska Verbaanderd and Lydie Meheus from the Anticancer Fund, has been published in Future Oncology, a highly respected cancer research journal with an international reach.

The discussion was prompted by a recent study published in the British Medical Journal (BMJ, Naci et al, 2019) that examined the design characteristics, risks of bias and reporting adequacies of pivotal randomised controlled trials of cancer drugs approved by the EMA in the period 2014–2016. It reported that 49% of trials were judged to be at high risk of bias based on aspects of their design, conduct or analysis. Only 26% randomised controlled trials measured overall survival as a primary end point, with the majority of trials evaluating surrogate metrics such as progression free survival or response rates. Furthermore, there were also discrepancies between scientific publications and regulatory documentation, thereby raising concerns of reporting inadequacies and risks of bias in both sources of information.

The editorial by the group from the Anticancer Fund assessed recent trends in oncology trials with the evidence suggesting that many new cancer drugs approved by EMA and the FDA are not delivering meaningful clinical benefit to patients. These findings add to the existing body of evidence that suggests drug development in oncology is not delivering the clinical benefits that are required to meet the high unmet needs of cancer patients. A number of recommendations are made to address this important medical issue.

Read the full article here
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