[Federal Register: March 23, 1999 (Volume 64, Number 55)]
[Notices]               
[Page 14001-14002]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23mr99-86]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

 
Public Comments Meeting on a Proposed Hematopoietic Cell 
Transplant Network

    Notice is hereby given of the NIH Public Comments Meeting on a 
Proposed Hematopoietic 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.
    The purpose of this meeting is to discuss a joint NHLBI/NCI effort 
to provide an opportunity for collaborative studies in hematopoietic 
cell transplantation. The objective is to organize a network of 
transplant centers to review current progress, design and conduct a 
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 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 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 
mechanisms 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 Webpages for public review. 
The implementation of this project will create a ``win-win'' situation 
for physicians, patients, federal agencies, and healthcare 
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.
    Individuals wishing to provide oral comments at the meeting, or to 
provide written comments, should contact: Henry Chang, M.D., Director, 
Blood Resources Program, NHLBI, Division of Blood Diseases and 
Resources, MSC 7950, 6701 Rockledge Dr., Room 10170,

[[Page 14002]]

Bethesda, MD 20892-7950, Phone: 301-435-0067, FAX: 301-480-1060, E-
Mail: changh@nih.gov.

    Dated: March 8, 1999.
Barbara Alving,
Director, Division of Blood Diseases and Resources.
[FR Doc. 99-6954 Filed 3-22-99; 8:45 am]
BILLING CODE 4140-01-M