Press Releases

Expert Meetings

  • CTTI Launches New Online Digital Health Trials Hub April 6, 2022
    CTTI Project: Developing Novel Endpoints, Planning Decentralized Trials Today the Clinical Trials Transformation Initiative (CTTI) announced a new online Digital Health Trials Hub featuring enhanced recommendations and additional resources. Download Press Release
  • CTTI Names Sally Okun as New Executive Director October 11, 2021
    The Clinical Trials Transformation Initiative (CTTI), a public-private partnership co-founded by Duke University and the U.S. Food and Drug Administration (FDA), today announced Sally Okun as its new executive director.
  • Investigators from Multiple U.S. Organizations Collaborate on First Embedded Pragmatic Clinical Trial Using National Health Plans’ Data September 1, 2020
    Today, at the ESC Congress 2020 – The Digital Experience, a group of U.S. investigators from several organizations announced their collaborative findings from the Implementation of a randomized controlled trial to imProve treatment with oral AntiCoagulanTs in patients with Atrial Fibrillation (IMPACT-AFib), the first trial to use the U.S. Food and Drug Administration’s (FDA) FDA-Catalyst System network of electronic health data from a diverse group of national health plan data partners.  Download Press Release (444.98 KB)
  • CTTI Releases New Recommendations and Resources for Using Real-World Data to Plan Trial Eligibility Criteria and Recruit Participants October 17, 2019
    CTTI Project: Real World Data During a public webinar today, the Clinical Trials Transformation Initiative (CTTI) will release new recommendations and resources on how to use real-world data (RWD) to evaluate trial eligibility criteria and recruit potential research participants.  Download Press Release (417.83 KB)
  • CTTI Releases Recommendations for Engaging Patients and Sites in Mobile Clinical Trials February 21, 2019
    During a public webinar today, the Clinical Trials Transformation Initiative (CTTI) will release new recommendations and resources for engaging patients and research sites when planning and conducting mobile clinical trials. By doing so, sponsors, contract research organizations, and other stakeholders can maximize the opportunities of mobile technologies to advance the development of new medical products.  Download Press Release (486.5 KB)
  • CTTI and FDA Convene Workshop on Including Patient Perspectives in Clinical Trials January 28, 2019
    The Clinical Trials Transformation Initiative (CTTI) will convene a public workshop, “Enhancing the Incorporation of Patient Perspectives in Clinical Trials,” in collaboration with the U.S. Food and Drug Administration (FDA) on Mon., March 18, from 9:00 a.m. to 5:00 p.m. at the Tommy Douglas Conference Center in Silver Spring, Md.  Download Press Release (262.53 KB)
  • CTTI to Support NIH Workgroup in Developing Evaluation Plan for Single IRB Policy December 13, 2018
    The National Institutes of Health (NIH) has selected the Clinical Trials Transformation Initiative (CTTI) to support a workgroup that will develop a comprehensive plan for assessing the NIH’s new single institutional review board (sIRB) policy. The policy, which became effective in January, requires U.S. sites participating in nonexempt multicenter human subjects research funded by the NIH to use a sIRB for ethical review, with the goal of improving the quality and efficiency of clinical research.  Download Press Release (128.03 KB)
  • CTTI Offers Path Forward for Using Decentralized Clinical Trials September 26, 2018
    The Clinical Trials Transformation Initiative (CTTI) will unveil new recommendations to speed the use of decentralized clinical trials (DCTs)-trials run through telemedicine and mobile health care providers-today at the DPharm: Disruptive Innovations to Advance Clinical Trials conference in Boston, Mass.  Download Press Release (267.49 KB)
  • CTTI Holds Special Event at the FDA to Launch Mobile Technologies Recommendations July 16, 2018
    In a special event at the U.S. Food and Drug Administration (FDA) today, the Clinical Trials Transformation Initiative (CTTI) will unveil recommendations for the use of mobile technologies in clinical research. The evidence-based recommendations and resources address an unmet need by outlining best practices for the use of mobile devices and applications to capture objective data-an approach that has the potential to increase the quality and efficiency of clinical trials.  Download Press Release (134.56 KB)
  • CTTI and the FDA Select Representatives for Patient Engagement Collaborative July 12, 2018
    The Clinical Trials Transformation Initiative (CTTI) and the U.S. Food and Drug Administration (FDA) announced newly selected representatives for the Patient Engagement Collaborative (PEC) today. The group of 16 patients, caregivers, and patient group representatives will meet with the FDA several times a year to discuss topics such as communication, transparency, and the best ways for patients to participate in the FDA’s regulatory discussions about medical products.  Download Press Release (280.48 KB)