Tipping the balance (unreported serious adverse drug reactions) Ovarian Cancer and Us OVARIAN CANCER and US Ovarian Cancer and Us

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Monday, March 21, 2016

Tipping the balance (unreported serious adverse drug reactions)

open access
Tipping the balance - Cover-Story - January-February-2016 Issue 70 - Cancer World - Shaping the future of cancer care

Almost four in ten serious adverse drug reactions now listed in the labels of 12 targeted cancer therapies were not mentioned in the studies that led to their approval. Half the serious reactions that were missed are potentially fatal. How can we improve the way we investigate and report the side effects of new drugs?

Questions are being raised about the accuracy and integrity of reports from pivotal clinical trials that provide the evidence for licensing cancer drugs. There is increasing concern that reports overstate the effectiveness of innovative drugs in a real world setting, because patients on trials are healthier and fitter than most of the people it will be used in, and understate side effects. This distorts the information used by clinicians to define the recommended dose, by regulators to assess the risk–benefit profile, and by patients to choose between treatment options.....


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