[New recommendations for evaluating the effectiveness of treatment of solid tumors and principles of the Guidelines for Clinical Practice (GCP)].
A new WHO protocol for measuring tumor during clinical studies using upgraded methods of tumor diagnosis was released in 1994. The recommendations based on the examination of over 4,000 patients included measuring greatest diameter of tumor and evaluation of treatment effect by changes of a sum total of largest diameters. Therapeutic effect is established by a decrease in the sum by at least 30%, while tumor progression--by an increase by at least 20%. The GCP provide standards for planning, implementing, monitoring, auditing and documentation of clinical trials and submitting their findings. These standards guarantee the accuracy and reliability of data, patients' rights of health protection and anonymity of those taking part in trials. Today, these rules are binding for the European Community, Japan and the USA. All Russian medical establishments running clinical tests are to observe the rules.
Gorbunova
V A
VA
N.N. Blokhin Center for Oncology Research, Russian Academy of Medical Sciences, Moscow.
Orel
N F
NF
Zaruk
V A
VA
D002986:Clinical Trials as Topic / Q000592:standards*; D005062:European Union; D005500:Follow-Up Studies; D006801:Humans; D007564:Japan; D009369:Neoplasms / Q000175:diagnosis / Q000628:therapy*; D017410:Practice Guidelines as Topic; D011788:Quality of Life; D012426:Russia; D013997:Time Factors; D014481:United States; D014944:World Health Organization