Clinical Trials Transformation Initiative (CTTI)
A Clinical Trials Transformation Initiative (CTTI) is a public-private partnership between Duke University and FDA co-founded in 2007 that identifies practices for increasing the quality and efficiency of clinical trial.
- Context:
- Example(s):
- Counter-Example(s):
- See: Decentralized Autonomous Organization (DAO), Decentralized Clinical Trial, Duke Translational Medicine Institute, Telemedicine, Decentralized Networking System, Decentralized Application (DApp).
References
2021
- (CTTI, 2021) ⇒ https://ctti-clinicaltrials.org/who_we_are/ Retrieved: 2021-09-25.
- QUOTE: At its most fundamental level, the Clinical Trials Transformation Initiative (CTTI) is a group of individuals and organizations that want to improve the quality and efficiency of clinical trials. It was co-founded by Duke University and the U.S. Food and Drug Administration in 2007 in an effort to identify and address challenges to well-designed, properly executed clinical trials, and offer recommendations to improve and modernize research.
2020a
- (Apostolaros et al., 2020) ⇒ Maria Apostolaros, David Babaian, Amy Corneli, Annemarie Forrest, Gerrit Hamre, Jan Hewett, Laura Podolsky, Vaishali Popat, and Penny Randall. (2020). “Legal, Regulatory, and Practical Issues to Consider When Adopting Decentralized Clinical Trials: Recommendations From the Clinical Trials Transformation Initiative.” In: Therapeutic Innovation & Regulatory Science Journal, 54(4).
- QUOTE: ... Traditional clinical trials are often expensive, inefficient, include selected populations, and can create significant participant burden via travel and other logistical demands. Using new technologies and methodologies to promote a decentralized approach has the potential to improve the efficiency of clinical trials. The Clinical Trials Transformation Initiative (CTTI) — a public–private partnership to improve clinical trials — launched a multi-stakeholder Decentralized Clinical Trials (DCTs) Project to provide recommendations on addressing the actual and perceived legal, regulatory, and practical challenges with DCT design and conduct in the United States. ...
CTTI’s recommendations cover protocol design, use of telemedicine and mobile healthcare providers, medical product supply chain, investigator delegation and oversight, and safety monitoring considerations. By implementing these recommendations, sponsors, contract research organizations, and others can help advance successful medical product development using mobile technologies and methodologies in DCTs. ...
- QUOTE: ... Traditional clinical trials are often expensive, inefficient, include selected populations, and can create significant participant burden via travel and other logistical demands. Using new technologies and methodologies to promote a decentralized approach has the potential to improve the efficiency of clinical trials. The Clinical Trials Transformation Initiative (CTTI) — a public–private partnership to improve clinical trials — launched a multi-stakeholder Decentralized Clinical Trials (DCTs) Project to provide recommendations on addressing the actual and perceived legal, regulatory, and practical challenges with DCT design and conduct in the United States. ...
2000b
- (CTSI-Duke University, 2020) ⇒ https://ctsi.duke.edu/what-we-do/clinical-trials-transformation-initiative-ctti
- QUOTE: (...) The Clinical Trials Transformation Initiative (CTTI) is a public-private partnership of over 80 members that strive to identify and drive adoption of practices that will increase the quality and efficiency of clinical trials.
CTTI was established in 2007 through a partnership between the FDA and Duke, and is administered through the Duke Translational Medicine Institute.
CTTI's approach includes conducting projects to better understand the range of current practices, assess alternative approaches, understand barriers to change, and propose recommendations for improvement. Funding from member organizations provides support for projects and infrastructure, according to a published fee schedule. The Executive Committee oversees the use of these funds.
Resources provided by the CTTI include:
- Recommendations
- Implementation Tools
- Expert Meeting Materials
- Publications
- Webinars
- QUOTE: (...) The Clinical Trials Transformation Initiative (CTTI) is a public-private partnership of over 80 members that strive to identify and drive adoption of practices that will increase the quality and efficiency of clinical trials.
2018
- (Huang et al., 2018) ⇒ (2018). "Clinical Trials Recruitment Planning: a Proposed Framework from the Clinical Trials Transformation Initiative". In: Contemporary Clinical Trials - Elsevier, 66, 74-79.
- QUOTE: To advance a more comprehensive approach to trial recruitment, the Clinical Trials Transformation Initiative (CTTI) convened a project team to examine the challenges and to issue actionable, evidence-based recommendations for improving recruitment planning. These activities were conducted as part of CTTI's mission to develop and drive adoption of practices that will increase the quality and efficiency of clinical trials (...)
2011
- (Grignolo, 2011) ⇒ Alberto Grignolo (2011). "The Clinical Trials Transformation Initiative (CTTI)". In: Annali dell'Istituto superiore di sanita, 47, 14-18.
- QUOTE: The Clinical Trials Transformation Initiative (CTTI) is a public-private partnership created in 2007 between the United States Food and Drug Administration (FDA) and Duke University for the purpose of identifying practices that will increase the quality and efficiency of clinical trials. The initiative was generated from the realization that the clinical trials system in the United States has been suffering as a result of increasingly longer study start-up times, slowing enrollment of patients into trials, increasing clinical trial costs, and declining investigator interest in participating in clinical trials.