PUBLIC COMMENTS MEETING ON A PROPOSED HEMATOPOIETIC STEM CELL TRANSPLANT NETWORK Release Date: April 1, 1999 P.T. National Heart, Lung, and Blood Institute Notice is hereby given of the NIH Public Comments Meeting on a Proposed Hematopoietic Stem Cell Transplant Network which will be held Tuesday April 6, 1999 in the Lister Hill Auditorium of the National Library of Medicine, National Institutes of Health, 9000 Rockville Pike, Bethesda, MD 20892. The conference begins at 8:30 a.m. on April 6 and will adjourn at approximately 4 p.m. The agenda will be available on the NHLBI Web page: http://www.nhlbi.nih.gov/nhlbi/nhlbi.htm The purpose of this meeting is to discuss a joint NHLBI/NCI effort to provide an opportunity for collaborative studies in hematopoietic stem cell transplantation. The objective is to organize a network of transplant centers to review current progress, design and conduct definitive clinical trials, generate and analyze data, and provide information to physicians, scientists, and the public. This resource will establish an infrastructure to expeditiously perform multi-center clinical trials, and improve therapies. It is hoped that the meeting will address the merits of the transplant network, recommendations as to the best structure and procedures to accomplish the desired goals, and suggestions as to the development and prioritization of studies to improve hematopoietic stem cell transplantation as a treatment for various diseases. The plan is to be flexible to the needs of the transplant centers, and it will be tested for 5 years. It is not intended to replace the R01 or P01 grant mechanisms. Hematopoietic stem cell transplantation is a curative therapy for a variety of hematologic diseases. In recent years, the number of transplant centers has increased, but there has been no simple mechanism for collaboration among them to address potentially pivotal clinical questions. While promising techniques have been tried, and encouraging pilot data obtained, definitive collaborative studies to improve efficacy and reduce toxicity have not been initiated in many areas. Frequently, clinical trials in this field have been performed at single institutions without controls, or used historic controls for comparison, or were retrospective and used matched contemporary controls. These kinds of studies are useful to generate hypotheses, and while a well-designed Phase II trial may be persuasive, the gold standard remains prospective, randomized, controlled trials, which are more difficult to perform. Not only is patient accrual hampered by investigator bias, competing protocols, rapidly changing technologies, and public perception, but many of the conditions treated are not prevalent. Even large medical centers may not have enough subjects for this type of study, and a mechanism to facilitate collaboration with other investigators is needed. This project attempts to address these issues, and is expected to provide a coordinated, flexible mechanism to accept ideas and build consensus from the transplant community, which will develop protocols for prompt evaluation. Furthermore, the role of physician bias and media hype in hampering accrual should be addressed by beginning randomized studies early, and posting data from completed trials, ancillary analyses, and interpretations on Web pages for public review. The implementation of this project will create a win-win situation for physicians, patients, federal agencies, and health care organizations. NHLBI and NCI propose to use a standard NIH competitive mechanism to support this network. The goal is to test new approaches generated by R01/P01 grants in a timely fashion through definitive trials, based on sound experimental designs. A national transplant trials group would be open to everyone, and accept input on how to prioritize the clinical trials. All interested individuals are invited to attend the public comments meeting. NIH staff will explain the purpose of the network, solicit comments, and answer questions. Directions to the building and information about accommodations in the area are available upon request. INQUIRIES Individuals wishing to provide oral comments at the meeting, or to provide written comments, should contact: Henry Chang, M.D. Division of Blood Diseases and Resources National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 10170, MSC 7950 Bethesda, MD 20892-7950 Telephone: (301) 435-0067 FAX: (301) 480-1060 Email: [email protected]

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