The Clinical Trials Transformation Initiative (CTTI) has named a 14-member executive committee, resetting CTTI’s strategic direction and ensuring that the organization informs and facilitates meaningful improvements to clinical trial design and conduct.

“Clinical trials are a critical component of how we develop medical evidence, and they are not meeting the societal need for answers about which strategies and therapies are most effective,” said Robert Califf, M.D., co-chair of the CTTI executive committee, vice chancellor for clinical and translational research at Duke University Medical Center, and director of the Duke Translational Medicine Institute. “We believe we can improve the system in a major way through focused effort of the entire clinical research community, including patients themselves. The CTTI executive committee understands the need to transform clinical trials, as well as how to do so in ways that align the mutual interests of patients, investigators and companies that develop medical products. Under this new leadership, CTTI will be able to make substantial improvements to the conduct of clinical trials.”

Established by the FDA and Duke University as a public-private partnership in 2007, CTTI comprises 60 member organizations working to identify practices that will improve the quality and efficiency of clinical trials. FDA and European regulators have cited this work in their efforts to modernize clinical trials.  

The CTTI executive committee includes distinguished U.S. and international thought leaders in government, academia, industry and patient advocacy who are experienced at envisioning and facilitating improvements in health care and medical research systems. 

“Because of the broad array of engaged stakeholders, CTTI is in a unique position to drive major changes in the clinical trial system in the midst of massive global reforms.” said Rachel Sherman, M.D., co-chair of the CTTI executive committee, and director for the office of medical policy at the Center for Drug Evaluation and Research, FDA. “There are a number of other initiatives focused on improving the clinical trials enterprise and our executive committee will enable us to better integrate and align these collective efforts.”

In addition to Califf and Sherman, the new CTTI executive board members are:

• Hans-Georg Eichler, MD, MSc, senior medical officer, EMA
• Michael Lauer, MD, director, division of cardiovascular sciences, National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health
• Elliott Levy, MD, senior vice president, global pharmacovigilance and epidemiology, Bristol-Myers Squibb
• Freda Lewis-Hall, MD, DFAPA, executive vice president and CMO, Pfizer
• Briggs Morrison, MD, executive vice president of global medicines, AstraZeneca Pharmaceuticals
• Garry Neil, MD, partner and head of R&D, Apple Tree Partners
• Richard Platt, MD, MSc, professor and chair, department of population medicine, Harvard, Pilgrim Health Care Institute and Harvard Medical School
• Nancy Roach, patient advocate, Colorectal Cancer Coalition
• Jean Rouleau, MD, FRCPC, FACC, scientific director, Institute of Circulatory and Respiratory Health of the Canadian Institutes of Health and Research
• Robert Temple, MD, deputy center director for clinical science, CDER,FDA
• Professor Tom Walley, CBE, MD, FRCP, director NIHR evaluations trials and studies, National Institute for Health Research
• Bram Zuckerman, MD, director of cardiovascular devices, Center for Devices and Radiological Health, FDA