Evaluation criteria for anticancer drugs: statistical differences or clinical benefits?

In recent years, there have been more and more randomized controlled trials (RCTs) on cancer treatment. The number of tumor-related RCTs published on PubMed from 2012 to 2016 exceeded 10 000, twice as many publications as in 2000-2004. How to evaluate such complex research results and apply these results to clinical decision-making is a question worth considering. The evaluation of the value of anti-cancer drugs includes not only its influence on the survival of patients, but also adverse reactions and economic factors. Therefore, we urgently need new standards to comprehensively evaluate the clinical benefits of anti-cancer drugs. Recently, the European Society for Medical Oncology (ESMO) and the American Society of Clinical Oncology have successively issued a standard for assessing clinical benefits, that is, Magnitude of Clinical Benefit Scale (ESMO-MCBS) and Value Framework (ASCO-VF). Through the above criteria, we have found that when evaluating clinical research results, statistical differences alone are not enough. The evaluation of clinical studies of anticancer drugs should be based on statistical differences, and aim at clinical benefit, in order to improve the survival of tumor patients.