A new CTTI publication, published in the Journal of Ethics and Human Research, explores stakeholder reflections on implementing the National Institutes of Health’s policy on single Institutional Review Boards (sIRB). CTTI interviewed 34 stakeholders with various roles in the single IRB process to gather perspectives about their experiences implementing the sIRB model, focusing specifically on the six goals of the NIH sIRB policy. Some stakeholders suggested that using the sIRB model has streamlined and reduced inefficiencies associated with local IRB ...

A recording of the virtual public meeting “Mitigating Clinical Study Disruptions During Disasters and Public Health Emergencies (PHEs),” convened by the U.S. Food and Drug Administration (FDA) and Clinical Trials Transformation Initiative (CTTI) held October 18th and 19th, is now available.   Day 1 of the virtual public meeting opened with welcoming remarks from Janet Woodcock, FDA’s Principal Deputy Commissioner. Following the opening remarks, Jacqueline Corrigan-Curay of the FDA’s Center for Drug Evaluation and Research (CDER) provided an overview of the FDA’s ...

Today, CTTI proudly announced Morgan Hanger as its next Executive Director.   “CTTI has been at the center of advancing clinical trial transformation through public-private collaboration, and that leadership will continue under Morgan Hanger,” said Dr. Mark McClellan, CTTI Executive Committee Chair, and Founding Director, Duke-Margolis Center for Health Policy. “Combined with Sally Okun’s lasting contributions, a thoughtful transition plan, and a strong team, CTTI is uniquely positioned—at critical time—to identify and support innovative strategies to speed the development of better clinical ...

Clinical trials are critical components of the evidence generating system in research. Launched in 2021, CTTI’s Transforming Trials 2030 vision outlines five pillars for how clinical trials should be performed by 2030. This vision establishes that clinical trials need to be patient centered and easily accessible, fully integrated into health processes, designed with a quality approach, maximally leveraging all available data, and improving population health. Currently, the TT2030 vision lacks metrics to demonstrate progress towards the vision’s five central goals. ...

The U.S. Food and Drug Administration (FDA), in collaboration with the Clinical Trials Transformation Initiative (CTTI), is convening a virtual public workshop to solicit input on increasing the enrollment of historically underrepresented populations in clinical studies and encouraging clinical study participation that reflects the prevalence of the disease or condition among demographic subgroups.   The free two-day virtual public workshop will be held on November 29 and 30, 2023, from 10 a.m. – 2 p.m. EST on both days. Registration for the ...

I wanted to let you know that after much consideration and reflection I am retiring from my position as Executive Director of the Clinical Trials Transformation Initiative by the end of 2023.   My time at CTTI has been incredibly rewarding both professionally and personally and my decision to retire was not an easy one. I am grateful for the support, opportunities, and camaraderie I have experienced throughout my time here. As I prepare to embark on a new chapter after five ...

The Food and Drug Administration (FDA), in collaboration with the Clinical Trials Transformation Initiative (CTTI), is convening a virtual public meeting on Oct. 18 and 19, 2023 to discuss recommendations provided by the FDA during the COVID-19 public health emergency (PHE) 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.” Registration for the meeting is now ...

The FDA and CTTI are currently accepting applications from patient advocates interested in becoming members of the Patient Engagement Collaborative (PEC). The PEC is an ongoing, shared forum in which the patient community (PEC members), FDA, and CTTI discuss a variety of topics such as improving communication, education, and patient engagement related to medical product regulation. Applicants will be selected based on their ability to meaningfully contribute to the PEC, represent and express the patient voice for their constituency, work in ...

A new CTTI publication, published in Digital Biomarkers, investigates the challenges sponsors encounter when using digitally derived endpoints and offers potential solutions. Digital health technologies – including mobile apps, smart devices, sensors, and wearables – can capture robust data from participants’ daily lives. These digital tools allow researchers to collect data for novel endpoints that can provide a broader view of health and treatment effects using measures that matter to patients. Despite these benefits to clinical trial quality and efficiency, ...

A recording of CTTI’s May 18 webinar unveiling the new recommendations on increasing diversity in clinical trials is now available.  The one-hour webinar includes a welcome from Sally Okun, CTTI; opening remarks from Richardae Araojo, U.S. Food and Drug Administration (FDA); a project overview from Luther Clark, Merck; a maturity model overview from Dawn Corbett, NIH; and a panel discussion moderated by Sara Calvert, CTTI. The panel discussion focused on stakeholder perspectives related to the integration of the of the new diversity ...