Patient Involvement With Life Threatening Diseases

"Respect for Patients' autonomy
is now considered
Fundamental to the practice of medicine."
Norman J. Levinsky, M.D.
New England Journal of Medicine
February 22, 1996

Patient Representatives

Patient Representative Program, The Patient Representative is responsible for providing the Food and Drug Administration (FDA) and the advisory committee the unique perspective of patients and family members directly affected by a serious or life-threatening disease. (September 13, 2001)
When a Patient Speaks ... Patient Representatives to FDA Advisory Committees, March 30, 1998
The Value of Patient's Perspective in the FDA Decision Process, Sharon Smith Holston, Deputy Commissioner, FDA, November 3, 1997
FDA Advisory Committees, FDA Dockets - information about contacts, background, transcripts and the Federal Advisory Committee Act
Getting Outside Advice for "Close Calls", by Dixie Farley, FDA Consumer Special Report on New Drug Development in the United States, January 1995
Cancer Patient Representative Nomination Package, current as of April 18, 2001
Patient Representative for the Antiviral Drugs Advisory Committee, current as of April 18, 2001
Guidelines for Speakers at the Open Public Hearing of an FDA Advisory Committee Meeting

Investigational Products

Participation of Racial/Ethnic Groups in Clinical Trials and Race-Related Labeling: A Review of New Molecular Entities Approved 1995-1999, Brenda Evelyn, Office of Special Health Issues, October 16, 2001.
Women's Participation in Clinical Trials and Gender-Related Labeling: A Review of New Molecular Entities Approved 1995-1999, Brenda Evelyn, Office of Special Health Issues, June 2001.
Draft Guidance for Industry - Information Program on Clinical Trials for Serious or Life-Threatening Disease; implementation Plan, June 2001, This is the second draft guidance document intended to assist companies when submitting clinical trial information to the Clinical Trials Data Bank as required by Section 113 of the Food and Drug Administration Modernization Action of 1997 (FDAMA) Text Version , PDF Version Federal Register Notice, July 9, 2001 Text Version , PDF Version
Why Should FDA Regulate Drugs?, An Interview with Janet Woodcock, M.D., Director of FDA's Center for Drug Evaluation and Research, by Tamar Nordenberg, FDA Consumer Magazine, September-October 1997
Understanding Clinical Trials From The Patient's Perspective, by Patty Delaney, Coping, May/June 1997
The FDA - What Does It Do For Cancer Patients?, by Patty Delaney, Coping, September/October 1997
Clinical Trials of Medical Treatments: Why Volunteer? (FDA 98-1294)
The Truth About Choosing Medical Treatments (FDA 00-1248)
[382K PDF file]
[HTML file]
Thalidomide Information Page, FDA/CDER information about thalidomide
Thalidomide: Potential Benefits and Risks, an open public scientific workshop, September 9-10, 1997, Natcher Conference Center, National Institutes of Health, Bethesda, Maryland
Executive Summary
Transcript for September 9, 1997, (approximately 140 pages)
Transcript for September 10, 1997 (approximately 100 pages)
Giving Thalidomide a Second Chance, by Herbert Burkholz, FDA Consumer, September-October 1997
Deadly Diseases and People of Color: Are Clinical Trials an Option?
Howard University, Washington, DC, October 25, 1996
University of Miami School of Medicine, Miami, FL, May 5, 1997
Treatment IND definition and discussion
Treatment INDs which were allowed to proceed, updated September 24, 1999 (current as of April 18, 2001)
Demographic Subgroups, Federal Register notice to amend regulations for NDAs to clearly define in NDA format and content regulations the requirement to present effectiveness and safety data for important demographic subgroups, specifically gender, age, and racial subgroups, February 11, 1998.

Related Information

National Institutes of Health Clinical Trials Database http://clinicaltrials.gov
The MedWatch Program is to enhance the effectiveness of postmarketing surveillance of medical products as they are used in clinical practice and to rapidly identify significant health hazards associated with these products. Visit the MedWatch page and learn how to work with your health care professional to report possible adverse reactions. The patients identity is kept confidential. This section also contains extensive information about the safety of medical products, with summaries of safety-related labeling changes presented on a month-by-month basis.
Cancer Liaison Program Index
HIV/AIDS Program Index
Consumer Drug Information, CDER, consumer drug information sheets which provide basic information about medications recently approved by the FDA.
Food & Drug Interactions, Many medicines have powerful ingredients that interact, and diet and lifestyle can sometimes have a significant impact on a drug's ability to work in the body. Certain foods, beverages, alcohol, caffeine can interact with medicines. This brochure (in PDF format) has information about possible interactions between many common prescription and nonprescription (over-the-counter) drugs with food, alcohol and caffeine. National Consumers League, 1998.
National Women's Health Information Center (NWHIC) the governments focal point for women's health issues.
Consumer Health Page, Agency for Healthcare Research and Quality (AHRQ)
Your Guide to Quality Health Care, was developed to help you make health care decisions using information about quality. The Guide is based on research about the information people want and need when choosing health plans, doctors, treatments, hospitals, and long-term care. These are the major decisions most people face at one time or another during their lives—either for themselves or for a loved one, Agency for Healthcare Research and Quality (AHRQ).
MEDLINEplus, information pages designed to direct you to resources containing information that will help you research your health questions.

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