Investigator-initiated trials are more impartial

Institution/investigator-initiated clinical trials in Canada.

Institution/investigator-initiated clinical trials in Canada require adherence to similar regulations and processes required of large pharmaceutical manufacturers. This may require an investigator to file a Clinical Trial Application. This article outlines the responsibilities and actions that are required prior to, during, and after the conduct of an institution/investigator initiated trial.

International models of investigator-initiated trials: implications for Japan.

BACKGROUND Academic/institutional investigator-initiated clinical trials benefit individuals and society by supplementing gaps in industry-sponsored clinical trials. MATERIALS In May 2010, experts from Japan, the Republic of Korea, the UK, and the United States, met at a symposium in Tokyo, Japan, to discuss how policies related to the conduct of clinical trials, which have been shown to be e...

Ohio CTSAs implement a reliant IRB model for investigator-initiated multicenter clinical trials.

Introduction E ff ective clinical and translational research is an essential component of improving human health as delineated in the National Institutes of Health (NIH) roadmap, 1,2 yet effi ciently conducting that research remains problematic. 3,4 Challenges include the high costs of conducting research, a shortage of qualified investigators, 5 low subject enrollment rates, 6,7 slow dissemina...

Analysis of the Current Clinical Research Management System of Investigator Initiated Trials in China

Clin. Invest. (Lond.) (2017) 7(4), 153–161 ISSN 2041-6792 Introduction The number of clinical trials in China has increased rapidly in recent years. According to the data available on the two clinical trial registries in the U.S. (www.clinicaltrials. gov) and China (www.chictr.org.cn), not only the number of clinical trials for new drugs, new medical devices and in vitro diagnostic assays has i...

Lipid Core Cost for Investigator-Initiated Services