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ECCO 2017 | The disadvantages of randomised clinical trials

Ian Tannock • 27 Jan 2017

Ian Tannock, MD, PhD, DSc, from the University of Toronto, Toronto, Canada, discusses the disadvantages of randomised trials at the European Cancer Congress of the European Cancer Organisation (ECCO) 2017 in Amsterdam, Netherlands. Randomised trials are considered the gold standard for testing novel treatments, however, there are some disadvantages. Firstly, participants are carefully selected, and will rarely have a comorbid disease. The drugs tend to therefore be more efficacious in clinical trials than they do in practice. Clinical trials are now commonly funded by pharmaceutical companies. This means that progression free survival is often used as an endpoint, as it is the minimum at which the FDA and the EMA will approve registration. An improvement in progression free survival, however, is not always indicative of an improvement in overall survival. Therapies shown to be statistically significant are usually approved by the FDA and the EMA, and new therapies can be expensive. Their cost, however, has no correlation to their efficacy. ESMO and ASCO have introduced value scales, balancing toxicity with the benefits, in the hope of determining clinically important treatment, not just statistically significant.