Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13
Before new prescription medicines are allowed onto the market, they must be tested in studies and show, to the satisfaction of drug regulatory agencies, that their benefits outweigh the harms of drug toxicity.
"Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13" source
"The most informative and valuable studies are those providing robust evidence from well designed randomised controlled trials that a new drug has a significant effect on outcomes that are important to patients and that the magnitude of those effects, compared with other treatment options, are clinically meaningful. Although the goal of cancer treatment is to improve the quantity and quality of life, clinical trials designed to gain regulatory approval for new drugs often evaluate indirect or “surrogate” measures of drug efficacy. These endpoints show that an agent has biological activity, but they are not reliable surrogates for improved survival or quality of life in all settings, and two recent systematic reviews suggest that the strength of association between surrogates in cancer clinical trials and life extension is generally low. Moreover, there is growing concern that the benefits offered by many new treatments for cancer—often discussed and promoted as “breakthroughs”—are marginal and might not be clinically meaningful to patients, despite rapidly escalating costs. Consequently, there have been calls to raise the evidence bar for market authorisation of new cancer drugs."
"Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13" source, read more