PILOT TRIALS ON INNOVATIVE THERAPIES FOR RHEUMATIC AND SKIN DISEASES

Release Date:  February 4, 1999

RFP AVAILABLE:  NIH-NIAMS-BAA-99-02

P.T.

National Institute of Arthritis and Musculoskeletal and Skin Diseases

The National Institute of Arthritis and Musculoskeletal and Skin Diseases
(NIAMS), in collaboration with the National Institute of Allergy and Infectious
Diseases (NIAID) and the Office of Research on Women's Health (ORWH), announces
the availability of a Broad Agency Announcement (BAA) which describes in general
terms a research topic and outlines proposal preparation requirements.  The
purpose of this BAA is to solicit proposals for small, pilot, and feasibility
clinical trials of innovative therapies for the treatment of rheumatic and skin
diseases.  The goal of this initiative is to accelerate the application of new
drugs, biologicals and other non-behavioral interventions for the short and long
term management of symptoms, signs, systemic and structural changes in patients
with established disease and for the development of strategies for prevention of
disease onset, progression or structural damage to target organs in patients at
high risk.  New and emerging agents for the treatment of lupus, rheumatoid
arthritis, scleroderma, myositis, Sjogren's and other rheumatic diseases are
included.  In the skin diseases area, inflammatory, autoimmune and genetic skin
diseases are included as are small trials for innovative therapies on wound
healing.  In addition, Human Immunodeficiency Virus (HIV)-associated skin and
rheumatic diseases are included as appropriate responses to this solicitation. 
To achieve the main goal of this BAA, the NIAMS seeks to support small, pilot and
feasibility trials.  The trials should be designed so that the preliminary data
obtained would be sufficient to either design the next phase (for example, Phase
II/III), for which the investigators will have to seek separate funding or obtain
evidence of efficacy where a large, double-blind, placebo-controlled trial is not
feasible.  Also appropriate will be proposals that include a short initial phase
to complete pre-clinical testing of highly promising products/approaches. 
Another goal of this BAA is to improve understanding of disease pathogenesis and
the underlying mechanism of action of new therapies.  In the context of the
clinical trials, ancillary studies are being sought.

It is anticipated that six cost reimbursement contract awards will be made for
a maximum period of four years beginning on or about September 30, 1999.  The
solicitation, NIH-NIAMS-BAA-99-02, will be available electronically on or about
February 8, 1999 and may be accessed through the Internet at the following
address: http://www.nih.gov/niams/grants/rfp/rfplist.htm.  Proposals will be due
on or about April 12, 1999.  Offerors are responsible for downloading their own
copy of the solicitation and amendments and for routinely checking the Internet
site for any possible solicitation amendments that may be issued by the
Government.  All responsible sources may submit proposals which will be
considered by the Government.  This advertisement does not commit the Government
to award a contract.

INQUIRIES

Inquiries may be directed to:

Valerie Syed
Contracts Management Branch, EP
National Institute of Arthritis and Musculoskeletal and Skin Diseases
45 Center Drive, Room 5AS13A, MSC 6500
Bethesda, MD  20892-6500
Telephone:  (301) 594-2543
FAX:  (301) 480-5996
Email:  syedv@mail.nih.gov

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