In a recent interview, the Director of the FDA’s Center for Drug Evaluation and Research (CDER), Dr. Janet Woodcock, was given the opportunity to share her vision for the center in 2015. When asked where she would most like to see advances in the realm of drug discovery, research, and development, Dr. Woodcock pointed to the need to reform the clinical trial system to reduce wastefulness. She cited CTTI’s role in analyzing and innovating different components of trial conduct and design; “I think we’ve made significant progress there,” stated Woodcock.

To read the transcript of the interview in full, click here.

CenterWatch’s Insider Insights is a semi-monthly publication that features organizations in the clinical trials space. Recently, Staff Writer Ronald Rosenberg sat down with CTTI’s Executive Director Pamela Tenaerts to discuss CTTI’s work. Their conversation touched upon the evolution of CTTI’s mission, which now includes an emphasis on the implementation of recommendations to improve clinical trial quality and efficiency. They also discussed CTTI’s pioneering approach to enhancing the patient voice, as well as the recently unveiled recommendations for streamlining GCP training practices. To read the article in full, click here.

“One of our biggest successes is [the] forum we created, in which there is trust for open dialogue… This atmosphere allows us to have all the stakeholders in clinical trials involved in being part of the solutions.”
-Pamela Tenaerts, M.D.

CTTI is pleased to announce the two newest additions to our Steering Committee, Diane Cook and Barbara LeStage.

As individual patient/caregiver representatives, they will collaborate with other stakeholders as equal partners to ensure that their unique perspective is represented in CTTI’s Steering Committee activities. These activities include analyzing existing research impediments and recommending consensus-driven, actionable solutions that will lead to a more sustainable and effective clinical trial system.

Cook and LeStage will be joining Stephen Mikita and Cynthia Geoghegan as individual patient/caregiver representatives at CTTI. To view a complete list of the membership organizations, including patient groups, click here.

We are honored to have such high quality patient/caregiver representatives to advocate for the patient voice at CTTI. Below, you will find additional information on each of our newest members.

 

Diane Cook

Diane Cook was diagnosed with Parkinson’s disease in 2008. She has participated in 10 clinical trials or research studies to date. Realizing the importance of the patient voice in clinical trials, Diane has gone on to partner with the research community to serve in roles such as co-principal investigator in hopes of developing higher quality, more efficient trials. Diane founded the Self-Efficacy Learning Forum (SELF) through which she has helped hundreds of recently diagnosed Parkinson’s patients increase their self-efficacy skills and behaviors to better manage their disease. She presented at the 2nd International Movement Disorders Congress in Sydney and served on the faculty of the 3rd World Parkinson’s Congress in Montreal. Her efforts to increase collaboration between the patient and research communities include the establishment of an annual Clinical Trial Research Forum in Denver, attracting hundred of patients and researchers, and a research study pairing local researchers and patients to identify opportunities and barriers to increased patient involvement in the research process. Diane serves as Patient Representative to the FDA, on the People with Parkinson’s Advisory Committee to the Parkinson’s Disease Foundation, as Colorado State Director for the Parkinson’s Action Network, as Advisory Committee Member of the University of Colorado Center for Movement Disorders and Neurorestoration.

 

Barbara LeStage

When Barbara was fifteen, her forty-one year old mother died of pancreatic cancer. In the 1970s her father was diagnosed with spindle cell carcinoma of the face requiring extensive surgery, radiation and plastic surgery. Barbara is a 19 year survivor of Stage 1 carcinoma of the breast. Her career as a cancer advocate began in 1975 when asked to volunteer for the American Cancer Society, eventually serving as Chair of the ACS Massachusetts Division Board and as a member the ACS National Board of Directors from 1988-1999. In 1993 Barbara’s focus began to shift to research advocacy. She served on three ACS national extramural research committees and the Council for Extramural Grants. She is past chair of the NCI Director’s Consumer Liaison Group (now the Council of Research Advocates) and a past member of NCI’s Central IRB, Advisory Committee to the Director, Informed Consent Template Update Working Group and Concise Informed Consent Document Planning Committee. She is currently serving as a member of NCI’s Clinical Imaging and Patient Advocate Steering committees and the Dana Farber/Harvard Cancer Center’s Breast Cancer Advocacy Group. Barbara chaired the Patient Advocacy Committee of the American College of Radiology Imaging Network (ACRIN) for seven years and was a member of protocol teams for two trials. She was a faculty member of the 2006 Clinical Trials Methodology Workshop conducted by the Radiological Society of North America. 2015 will be her fifth year as a faculty member of the ASCO/AACR Methods in Clinical Cancer Research Workshop.

Barbara received a B.S. from Denison University and a Master of Health Professions degree from Northeastern University’s Bouvé College of Pharmacy and Health Sciences. She is a graduate of the National Breast Cancer Coalition’s Project LEAD and the American Cancer Society’s Stakeholder Training. She twice attended the American Association for Cancer Research’s Scientist-Survivor program.