Author/Editor		Zwitter, Matjaž
Title		Implications of evidence-based medicine for the methodology and ethics of randomised clinical trials
Type		članek
Source		In: Zwitter M, Ećimović P, editors. Advanced course on ethics in oncology: program and course material; 2000 Jun 25-28; Bled. Ljubljana: Institute of oncology,
Publication year		2000
Volume		str. 113-7
Language		eng
Abstract		Evidence-based medicine may influence our approach to clinical trials. When preparing a systemic review, the quality of individual trials is of far greater importance than their individual results. Unbiased randomisation, attention to the treatment protocol and to the rules of good clinical practice and honest evaluation of experience are essential; less important are the power of an individual trial and statistically significant difference between the treatment arms. The recruitment period should be short and preferably not longer than three years, followed by timely publication of a report. Since systematic reviews and meta-analyses include and quote all available information, clinical researches and editors should be less influenced by publication bias. These changes in methodology open clinical trials to new innovative ideas difficult to test in large multi-institutional trials, rend clinical investigators less dependent on commercial sponsors and might bring more patients into clinical research. Greater respect of the autonomy of individual physicians and less interference with the uncertainty principle could contribute to reduced ethical costs.
Descriptors		EVIDENCE-BASED MEDICINE RANDOMIZED CONTROLLED TRIALS ETHICS, MEDICAL CLINICAL PROTOCOLS PROFESSIONAL AUTONOMY CLINICAL TRIALS, PHASE II PATIENT SELECTION