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: pgibbons@nih.gov
Return to NIH Guide Main Index
Office of Extramural Research (OER) |
National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892 |
Department of Health and Human Services (HHS) |
||||||||