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New CTTI Steering Committee Positions Open for Patient/Caregiver Representative(s)

Posted on by Hannah Faulkner

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 for projects, participate in their conduct and analysis, and are committed to disseminating CTTI recommendations and encouraging adoption of system changes that will improve the efficiency and quality of clinical trials. 

To learn more about this opportunity and apply, please visit the patient/caregiver page on our website.  You can also meet our current patient/caregiver representatives. 

Recording Now Available: CTTI Unveils New Tool for Embedding Clinical Trials into Clinical Practice

Posted on by Hannah Faulkner

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 trials, such as patient identification, informed consent, and data acquisition, into routine care reduces duplication of trial and care activities and promotes the development of a learning health care system. This can naturally lead to better decision-making,  treatment options, and outcomes for patients.  

This tool is a part of CTTI’s Embedding Trials in Clinical Practice work, which aims to enable health care settings to participate in embedded trials and assists sponsors with their design and conduct.  

View the slide deck to learn more. 

CTTI to Launch New Embedding Trials Feasibility Assessment Tool

Posted on by Hannah Faulkner

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 patient identification, informed consent, and
data acquisition, into routine care reduces duplication of trial and care activities and promotes the
development of a learning health care system. This can naturally lead to better decision-making,
treatment options, and outcomes for patients. 

However, integrating interventional clinical trials into clinical practice is complex, and operational direction is needed. Supporting recently released recommendations, CTTI created a new tool that aims to aid sponsors involved in early planning and design of a clinical trial by providing insight into site readiness and feasibility of integrating trials into clinical practice. 

Register for the free 60-minute webinar. 

Report Now Available: Mitigating Clinical Study Disruptions During Disasters and Public Health Emergencies

Posted on by Hannah Faulkner

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 of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency, Guidance for Industry, Investigators, and Institutional Review Boards.” The meeting also featured speakers and panelists from across the clinical trials enterprise, including representatives from Medtronic, the National Cancer Institute (NCI), the National Institutes of Health (NIH), Roche, and many more, who shared the experiences, best practices, and strategies they used to effectively navigate disruptions to clinical studies during the COVID-19 public health emergency.  

The meeting fulfilled a requirement under section 3605 of the Food and Drug Omnibus Reform Act of 2022 (FDORA). For more information about this meeting, visit CTTI’s website to view the resources including the final report, the presentation slides and the recording of the meeting.