CLINICAL COORDINATING CENTER FOR FEASIBILITY STUDIES ON RETINOID TREATMENT IN
EMPHYSEMA

Release Date:  January 29, 1999

RFP AVAILABLE:  NHLBI-HR-99-02

P.T.

National Heart, Lung, and Blood Institute

The overall objective of this research contract program is to conduct
feasibility studies at four to five clinical centers on the use of retinoids
in the treatment of emphysema.  The specific objectives of the program are to
identify optimal patient populations, retinoids, doses, dosing schedules,
routes of administration, and outcome measures preparatory to conducting a
larger, controlled, clinical trial on the efficacy of retinoid therapy in the
management of emphysema, should such a study be indicated.  This program will
be conducted in three phases.  During Phase I (6 Months), investigators will
meet to discuss, critique, and assess the complementary aspects of their
respective protocols, develop common definitions, standardize common
procedures across centers, develop cooperatively common data reporting
formats, and establish and train staff.  During Phase II (up to 24 Months),
each investigator will be expected to recruit, enroll, treat, and follow
emphysema patients according to their protocol.  Investigators will collect
and forward data to the Clinical Coordinating Center (CCC).  During Phase III
(6 Months), investigators will interact with other study investigators and the
Project Office in the preparation and writing of reports and manuscripts for
publication and work with the CCC to provide data and related information
necessary for data analysis.  A clinical center awarded a contract (RFP NHLBI-
HR-99-01) will execute its protocol according to the technical approach it has
proposed, though clinical center contractors shall work collaboratively during
Phase I to refine complementary aspects of their respective protocols, develop
common definitions, consider common outcomes, standardize common procedures
across centers, develop cooperatively common data reporting formats, and
generally work so that the different studies are comparable and complementary. 
The CCC will be responsible for 1) assuming leadership in areas of statistical
analyses, including sample size determinations, for each study and across
studies; 2) participating in a cooperative effort with the other investigators
in the formation of a Steering Committee, development of comparable and
complementary protocols, development and testing of compatible reporting forms
for each study, and development of the manual of operations; 3) preparing the
agendas for, coordinating, and managing the meetings and calls of the Steering
Committee, its subcommittees, and the Data and Safety Monitoring Board; 4)
preparing and distributing minutes of Steering Committee meetings; 5)
standardizing, printing, and distributing reporting forms, the study
protocols, and manual of operations; 6) developing and establishing methods
for data entry, data collection, and data transmission and training clinical
center staff in these methods; 7) receiving, collecting, processing, storing,
and analyzing data collected from the clinical centers; 8) assuring that data
are forwarded in accordance with an established time schedule and are reviewed
for accuracy and completeness; 9) assuring that quality control is maintained
during the collection and processing of all measurements; and 10) describing
the progress of the program and program results to the Steering Committee,
Program Office, and the Data and Safety Monitoring Board; 11) preparing and
distributing periodic technical and statistical reports, and 12) cooperating
in the reporting of the data results.  The proposed staff of the CCC must have
demonstrated experience in conducting multi-center trials, in working with
clinical investigators from multiple sites, in the development of study
protocols and Manual of Operations, in the monitoring the clinical centers to
ensure that data are reviewed for completeness and that quality control is
maintained prior to processing, and in conducting proper statistical analyses
of the data.  The staff must have appropriate biostatistical and statistical
experience relevant to multi-center clinical research studies.  Meta-analysis
methodology may be necessary to analyze data across studies.  The Principal
Investigator must have demonstrated leadership experience in large data
management systems, in protocol development for large multicenter studies, and
interaction with clinical center investigators from multiple sites.  The CCC
must have regular commitment of a physician(s) with strong medical and
scientific knowledge and experience in care and treatment of patients with
emphysema.  The Steering Committee will be composed of the principal
investigator from each site, the clinical coordinating center and
representatives from the NHLBI.  The Steering Committee will meet three times
in Phase I, twice a year in Phase II, and twice in Phase III.  An independent
Data and Safety Monitoring Board appointed by the NHLBI will oversee the
safety of all research protocols.

This is not a Request for Proposals (RFP).  It is anticipated that RFP
NHLBI-HR-99-02 will be available on or about January 23, 1998, with proposals
due on or about March 22, 1999.  The RFP will be available electronically at
the following URL: http://www.nhlbi.nih.gov/nhlbi/rafs/rfas.htm.

INQUIRIES

Inquiries regarding this notice may be directed to:

Ms Joanne Deshler
Telephone:  (301) 435-0340
Email:  jd52g@nih.gov.

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