he Clinical Trials Transformation Initiative (CTTI) identifies and promotes practices to increase the quality and efficiency of clinical trials through projects that generate empirical data on how trials are currently conducted, leading to recommendations for improvement.
- Clinical trials: rethinking how we ensure quality. Drug Inf. J. 46, 657–660 (2012). et al.
- Optimizing expedited safety reporting for drugs and biologics subject to an investigational new drug application. Ther. Innov. Regul. Sci. 48, 200–207 (2013). et al.
- US FDA. Investigational new drug safety reporting requirements for human drug and biological products and safety reporting requirements for bioavailability and bioequivalence studies in humans. Fed. Regist. 75, 59935–59963 (2010).
- The paradoxical problem with multiple-IRB review. N. Engl. J. Med. 363, 1591–1593 (2010).
- Using central IRBs for multicenter clinical trials in the United States. PLoS ONE 8, e54999 (2013). et al.
- Supplementary information S1 (figure) (167 KB)
Clinical Trial Transformation Initiative member organizations