Abstract
s / Resuscitation 96S (2015) 43–157 119 makes it difficult to obtain informed consent (IC) for clinical studies/trials. Some countries have codified the conditions inwhich the necessity of trial consent is waived in emergency research. Inmany countries, however, IC requirement remains a formidable barrier to conducting such studies. It is important to examine which conditions are effective and advisable in promoting clinical studies/trials in this field. Methods: From the WHO ICTRP (International Clinical Trials Registry Platform) database, trial information, registered in the between 2005 and 2014, was extracted and aggregated for several European countries, the United States and Japan. Overall numbers of registered trials, and those in emergency situations (entries which have “emergency” in title, condition or intervention) were counted. They were tabulated by the study design and countries. Results: Overall, 79,998 clinical trials were registered during the study period. Among this, the number of global clinical trials was 9296(11.6%). The total number of randomised controlled trial (RCT)was 30,717 (38%). Thenumbers of trialswithRCTdesignwere 12,022 (15%) in Europe, 10502 (13%) in the U.S., and 13,317 (17%) in Japan. Among all of clinical trials, 286 (0.36%) were the number of emergency clinical trials; 68 (24%) in Europe, 91 (32%) in the U.S., and 24 (8%) in Japan. The proportions of emergency trials with RCT among all RCT clinical trials in each country were 0.32% in Europe, 0.53% in the U.S., and 0.05% in Japan. Conclusion: There are not many clinical trials conducted in emergency situations. The case is more remarkable with RCTs. This might reflect the difficulty in implementing research due to the conditions and considerations specific to this field. However, the number of RCTwas relatively larger in the U.S., where the guidance on exception from informed consent requirements for emergency research was issued by its regulatory authority. More international exchange of information and discussion is advisable.1,2
Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
