NEW ANTIPSYCHOTIC DRUG TRIALS

Release Date:  November 6, 1998

RFP AVAILABLE:  NIMH-99-DS-001

P.T.

National Institute of Mental Health

The National Institute of Mental Health (NIMH) proposes to issue a
solicitation (RFP) No. NIMH-99-DS-0001 entitled "New Antipsychotic Drug
Trials" as Full and Open Competition under SIC Code 8093. 

The NIMH plans to award a five-year cost-reimbursement contract, and plans to
make the award by June 15, 1999.  This will be the initial award for this
requirement. 

The purpose of this contract is to study the comparative efficacy and
effectiveness of the new atypical antipsychotics through a series of clinical
trials in patients with schizophrenia, patients with psychotic depression, and
patients with Alzheimer's disease.  These trials will be based on a public
health model of interventions research, with a focus on effectiveness and
outcome, rather than efficacy alone.  Psychotic symptomatology will be
examined, but so will broader outcomes, including compliance, residual
disability, recovery from illness, and long term vocational and social
function. 

A major objective is generalizability, and the trials will be as inclusive as
possible.  Patients will be carefully diagnosed, characterized, and stratified
within trials, but comorbid psychiatric or medical disorders will not be
excluded (except for safety reasons).  A premium will be placed on demographic
(age, sex, and race) and geographic (urban and rural) diversity.  Multiple
treatment and residential settings will be studied.  These trials will be
useful only if their findings affect actual clinical practice.

NIMH anticipates and strongly encourages collaboration between multiple
research centers and between academic institutions and private businesses in
submitting proposals. An offeror may participate in multiple proposals as
subcontractor, co-investigator, or offeror, and may be the Principal
Investigator (PI) on a subcontract in more than one proposal. However, an
offeror may be overall PI or primary contractor on only one proposal. The
overriding concern is the technical merit and scientific quality of the
individual trials, and NIMH reserves the right to eliminate one or even two
trials from a proposal if they are deemed insufficiently meritorious.

Only FDA approved, marketed antipsychotics will be studied, but there will be
a mechanism for adding new drugs to the trial as they are released.  The
trials will provide data on the optimum choice of antipsychotic in different
subgroups, appropriate dose range, and any unique safety issues within each
group.  The primary independent variable will be the new drugs, but
interactive effects with psychosocial intervention and treatment setting will
be examined as well.

The specific aims and hypotheses tested in a trial will differ based on the
diagnostic group studied.  However, NIMH recognizes that the breadth of
objectives and desire for generalizability mean that these trials will to a
certain degree be descriptive and will generate hypotheses to be tested in
future studies.  One of the anticipated results of the present initiative is
the development of a network of sites and investigators able to respond to
future needs for outcome focused treatment research.

Request for Proposal (RFP) No. NIMH-99-DS-0001 will be available on or about
November 2, 1998 and the receipt date of proposal on or about January 25,
1999.  The RFP may be accessed through the NIMH Home Page by using the
following instructions: access the home page at http://www.nimh.nih.gov, first
select "Grants and Contracts," click on "Contracts," select "NIMH Request for
Proposals (RFP)," and lastly select "NIMH-99-DS-0001."

Please note that the RFP for this requirement will include the Statement of
Work, Deliverables and Reporting Requirements, the Technical Evaluation
Criteria, and proposal preparation instructions.  All information required for
the submission of an offer will be contained in the electronic RFP package. 
Following proposal submission and initial review process, offerors comprising
of the competitive range will be requested to provide additional documentation
to the Contracting Officer.  All responsible sources may submit a proposal
that will be considered by the NIMH.  This advertisement does not commit the
Government to award a contract.

INQUIRIES

Inquiries may be directed to:

Patricia L. Gibbons, Contracting Officer
Contracts Management Branch
National Institute of Mental Health
5600 Fishers Lane, Room 9C-15
Rockville, MD  20857-8030
Telephone:  (301) 443-2696
Email:  [email protected]

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