December 9, 2010
8:00 a.m. – 5:30 p.m.
December 10, 2010
8:00 a.m. – 1:00 p.m.
Workshop Goals and Objectives
The Food and Drug Administration (FDA) is announcing a two-day public workshop entitled “Product Development Program for Interventions in Patients with Severe Bleeding Due to Trauma or Other Causes.” The purpose of this public workshop is to discuss possible paradigms for the evaluation of products indicated for use to stop severe bleeding. The public workshop will include presentations and panel discussions by experts from academic institutions, government agencies and industry.
Severe bleeding may be encountered in both traumatic and non-traumatic clinical situations. New products for the treatment of severe bleeding are needed to reduce the need for blood transfusions, minimize complications resulting from blood loss and improve patient outcomes. The development and approval of new products for use in treatment of severe bleeding, particularly severe bleeding resulting from trauma, has been complicated by the lack of a consensus definition of severe bleeding as well as the need to identify appropriate clinical endpoints for assessment of product safety and efficacy. Clinical endpoints may vary depending on the product indications, patient characteristics, nature of injury, whether the product acts locally or systemically, the nature of the product (e.g., device, drug, biologic, or combination) and conditions of use.
Because it may not always be feasible to obtain standard informed consent, clinical trials of products used for the treatment of life-threatening severe bleeding resulting from trauma may raise significant ethical and legal considerations. Researchers studying products for use in such circumstances may need guidance to carry out appropriate consultation with representatives of the communities in which the clinical investigation will be conducted and from which the study participants will be selected. Clinical trials on products intended for use in trauma are also complicated by the difficulty of identifying patients who may meet study inclusion criteria. Given these challenges, further discussion is needed about how products approved for use for treatment of severe bleeding occurring during surgery or due to non-surgical conditions may best be evaluated for use in treatment of severe bleeding in trauma.
The first day of the workshop will include presentations and panel discussions on the following topics: (1) Current clinical scientific knowledge concerning the pathophysiology of trauma and assessment of severe bleeding; (2) currently available locally acting and systemic products used to treat severe bleeding in trauma and non-trauma settings; (3) animal models for pre-clinical evaluation of products; (4) ethical considerations for clinical trials to evaluate products used in treatment of severe bleeding in trauma; and (5) clinical evaluation of products for bleeding interventions, including clinical trials and endpoints. The second day of the workshop will include a discussion of whether products with an indication for use in severe bleeding due to trauma can be evaluated in clinical settings other than a trauma clinical trial and a summary of the sessions presented at the workshop.
10 Center Drive, Building 10
National Institutes of Health*
Bethesda, MD 20892
*Please visit http://www.nih.gov/about/visitor/index.htm for NIH campus maps and NIH visitor information on security requirements, visitor parking and public transportation.
There is no registration fee for the workshop. Early registration is recommended before November 19, 2010, as seating is limited. Registration on the day of the workshop will be provided on a space available basis beginning at 7:30 a.m. To register, complete the attached registration form in this announcement and mail, fax or e-mail it to Rhonda Dawson, Food and Drug Administration, HFM-302, 1401 Rockville Pike, Rockville, MD 20852; Fax: 301-827-2843; E-mail: email@example.com Registrants will receive an e-mail confirmation.
If you need special accommodations due to a disability, please contact Rhonda Dawson at least seven days in advance of the workshop.
Food and Drug Administration
Office of Blood Research & Review
Center for Biologics Evaluation and Research
1401 Rockville Pike, HFM-302
Rockville, MD 20852