CLINICAL CENTERS FOR PRELIMINARY STUDIES ON RETINOIC ACID TREATMENT IN EMPHYSEMA

Release Date:  November 25, 1998

RFP AVAILABLE:  NHLBI-HR-99-01

P.T.

National Heart, Lung, and Blood Institute

The overall objective of this Broad Agency Announcement research contract program
is to conduct preliminary studies preparatory to conducting a randomized,
controlled, clinical trial on the efficacy of retinoic acid therapy in the
management of emphysema.  Objectives are to identify optimal patient populations,
drugs and dosing schedules, and outcome measures for a larger study, if
indicated.  It is expected that proposals submitted in response to this RFP for
Clinical Centers will have varying technical approaches, but will have many
measures and procedures in common.  It is expected that this program will involve
4-5 clinical centers and a Data Coordinating Center.  A separate request for
proposals will be released for the Data Coordinating Center.  Offerors will be
expected to submit protocols that have been reviewed and approved by their
Institutional Review Board.  During Phase I (3 Months), investigators will meet
to discuss, critique, and assess the complementary aspects of their respective
protocols, develop common definitions, standardize procedures across centers,
develop cooperatively common data reporting forms, and establish and train staff. 
During Phase II (up to 27 Months), investigators will be expected to recruit,
enroll, treat and follow patients according to their protocols.  Investigators
will collect and forward data to the Data Coordinating Center.  During Phase III
(6 Months), investigators will interact with other study investigators in the
preparation and writing of reports and manuscripts for publication and work with
the Data Coordinating Center to provide data and related information necessary
for data analysis.  Offerors will be required to document access to the patient
population proposed and specific plans for recruitment and patient
retention/follow-up.  Offerors must include sample size justifications and plans
for data collection, management and statistical analysis.  A Data Coordinating
Center will collect, verify, store and analyze data from the Clinical Centers and
describe the progress of the study to the Steering Committee, Program Office and
the Data and Safety Monitoring Board (DSMB).  The Steering Committee will be
composed of the principal investigator from each site, the data coordinating
center and a representative from the Program Office.  The Steering Committee will
meet twice a year to review progress of the studies.  An independent DSMB will
be appointed by the NHLBI to oversee the safety of all research protocols.

This is not an RFP.  It is anticipated that RFP NHLBI-HR-99-01 will be available
on or about December 1, 1998, with proposals due on or about March 15, 1999.  The
RFP will be available via the NHLBI Website at:
http://www.nhlbi.nih.gov/nhlbi/rafs/rfas.htm.

INQUIRIES

Correspondence regarding the RFP may be directed to:

Mr. Douglas Frye
Heart, Lung, and Vascular Diseases Contracts Section
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 6106
Bethesda, MD  20892
Telephone:  (301) 435-0340
Email:  df23a@nih.gov

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

Department of Health and Human Services

National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892