Despite widespread support for decentralization, real and perceived challenges remain, limiting wider implementation of decentralized elements. A new CTTI publication, published in the Journal of Therapeutic Innovation & Regulatory Science, explores three perceptions that are commonly heard as barriers to the adoption of decentralized approaches in clinical trials. Because the integration of these approaches has the potential to enhance accessibility, diversity, and to reduce the burden on participants and caregivers, it is crucial to understand which barriers can be readily ...

One of the ways that the Clinical Trials Transformation Initiative (CTTI) engages with and integrates patients into our work is by having patient/caregiver representatives on our Steering Committee. We are currently accepting applications for this position until 11:59 p.m. ET, Tuesday, April 2. We are looking for patients or caregivers who are self-starters, have personal experience and familiarity with clinical trials, and can work with stakeholders across the research community.  During their three-year term, CTTI Steering Committee patient/caregiver representatives contribute ideas ...

A recording of CTTI’s Feb. 29 webinar unveiling a new tool that aids in assessing the feasibility of embedding clinical trial elements into clinical practice is now available.  The one-hour webinar included a welcome from CTTI Director of Projects Sara Calvert; a project overview from CTTI Senior Project Manager Lindsay Kehoe; a panel discussion focused on stakeholder perspectives related to the practical use of the tool; and a request for input on how to optimize the tool’s use.   Embedding elements of clinical ...

CTTI will host a free public webinar on Thursday, Feb. 29 at 12:00 p.m. EST to unveil a new tool for assessing the feasibility of embedding clinical trial elements into clinical practice.   The webinar will include a welcome from Sara Calvert; a project overview from Lindsay Kehoe; a panel discussion that will focus on stakeholder perspectives related to the practical use of the tool; and an opportunity for you to help CTTI optimize its use.  Embedding elements of clinical trials, such as ...

The report on the two-day virtual public meeting, “Mitigating Clinical Study Disruptions During Disasters and Public Health Emergencies (PHEs),” convened by the U.S. Food and Drug Administration (FDA) in collaboration with the Clinical Trials Transformation Initiative (CTTI), is now available.  The meeting, which was held on October 18 and 19, 2023 with 720 global attendees, discussed recommendations provided by the FDA during the COVID-19 public health emergency to mitigate disruption of clinical studies, including recommendations detailed in the guidance entitled “Conduct ...

Timely, accurate, and complete registration and reporting of summary results information for applicable clinical trials on ClinicalTrials.gov allows access to current research and evidence for all partners in the clinical trials enterprise, including patients, providers, sponsors and investigators, regulators, payers, and health system leaders. Despite the regulatory requirements for applicable clinical trials and the importance of fostering transparency while increasing knowledge of potential new treatments in development, multiple publications have reported gaps in clinical trial registration and results information submission ...

Today, the U.S. Food and Drug Administration (FDA) and the Clinical Trials Transformation Initiative (CTTI) announced eight newly selected representatives for the Patient Engagement Collaborative (PEC). The group of 16 patients, caregivers, and patient group representatives meets with the FDA several times a year and discusses a variety of topics such as improving communication, education, and patient engagement related to medical product regulation. Those selected to the PEC are expected to serve for two years.  The eight new representatives are:   Anna Ball  Kelly ...

Today, Sally Okun, who has served as CTTI’s Executive Director since October 2021, is retiring after five decades in healthcare.   “On behalf of the entire CTTI community, we congratulate Sally on her exceptional career and on her retirement,” said CTTI’s incoming executive director, Morgan Hanger. “Sally’s tenacity and gift for storytelling have had a remarkable impact on bringing person-centered research and care into the mainstream. As we move into a phase of AI-driven innovation, her vision for ethical, patient-led data ...

Throughout this year, we’ve had the pleasure of crossing paths with many of you at diverse locations around the world – from San Francisco and Boston, to the nation’s capital and the Big Apple, to Montreal and Riyadh. We shared our work at more than two dozen meetings, conferences, and events, and it’s been truly gratifying to see our community actively engaged in our work on a global level.  In 2023, CTTI has redefined possibilities around some of the clinical trials ...

A recording for the virtual public workshop to enhance clinical study diversity convened by the U.S. Food and Drug Administration (FDA) and Clinical Trials Transformation Initiative (CTTI), held November 29 and 30, is now available.   Day 1 of the virtual public workshop opened with welcoming remarks from Karen A. Hicks, Deputy Director of the FDA’s Office of Medical Policy (OMP). Following the opening remarks, Patrizia Cavazzoni, Director of the FDA’s Center for Drug Evaluation and Research (CDER), delivered the keynote address. Following ...