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.
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.
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.
