CTTI now comprises more than 80 organizations from across the clinical trial enterprise. Members include representatives of government agencies, industry representatives, patient advocacy groups, professional societies, investigator groups, academic institutions, and other interested parties.
CTTI Policy Impact
CTTI has been cited in the NIH draft Policy on single IRB of record in multi-center trials, the FDA’s newest draft guidance on IND safety reporting, the FDA's Guidance on Risk-Based Monitoring, an EMA Reflection Paper, and 21st Century Cures.
Adoption of CTTI's QbD Framework
CTTI’s Quality by Design framework is being used at AstraZeneca, DCRI, The Medicines Company, PCORNET, Pfizer, Seattle Genetics, Target Health Inc, and the University of Oxford.
Adoption of Central IRB's
CTTI’s Central IRB tools & recommendations have been implemented at Celgene Corporation, National Institute of Neurological Disorders and Stroke (NIH), and North Shore-LIJ Health System.