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 þPhase
IIþ trial may be persuasive, the þgold standardþ 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 þwin-winþ
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: changh@nih.gov


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