National Institute of Mental Health, Contracts Management Branch, 5600 Fishers Lane, Rm. 9C-15, Rockville, MD, 20857-8030

A -- CLINICAL TRIALS OF THE NEW ANTIPSYCHOTICS SOL NIMH-98-RFI-01 DUE 090998 POC Patricia Gibbons, Contracting Officer, (301)443-2696 E-MAIL: Click here to contact the contracting officer via, pgibbons@mail.nih.gov. REQUEST FOR INFORMATION -- NIMH-98-RFI-01 "CLINICAL TRIALS OF THE NEW ANTIPSYCHOTICS" This Request For Information (RFI)/Sources Sought Notice (SS) is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the National Institute of Mental Health (NIMH). The purpose of this RFI/SS is to identify potential sources that may be interested in and capable of performing the work described herein. NIMH welcomes comments from all individuals on each or all of these questions. The NIMH does not intend to award a contract on the basis of responses nor otherwise pay for the preparation of any information submitted or NIMH's use of such information. Acknowledgment of receipt of responses will not be made, nor will respondents be notified of the NIMH's evaluation of the information received. As a result of this RFI/SS, the NIMH may issue a Request for Proposals (RFP). In the event a RFP will be issued, Standard Industrial Classification (SIC) code 8093 will apply. However, should such a requirement materialize, no basis for claims against the NIMH shall arise as a result of a response to this RFI or the NIMH's use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement. Request for Information: The NIMH seeks input and comment on its plans to study the comparative efficacy and effectiveness of the new atypical antipsychotics. NIMH intends to award a single contract with multiple scientific and administrative components to conduct trials of these drugs in patients with schizophrenia, patients with psychotic depression, and patients with dementia. NIMH expects to fund three, scientifically independent treatment trials along with a shared administrative/logistical core. 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, coinvestigator, 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. The trials will be based on a public health model of interventions research, with a focus on effectiveness and outcome, rather than efficacy alone. They will also examine cost-effectiveness and the impact of external factors on treatment delivery, compliance, and eventual outcome. A major objective is generalizability: the trials will be as inclusive as possible; a premium will be placed on demographic (age, sex, and race) and geographic (urban and rural) diversity; and multiple treatment and residential settings will be included. Subjects with comorbid disorders (e.g., drugabuse) will not be excluded, and will be actively recruited. Only FDA approved, marketed antipsychotics will be studied. 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. At this time NIMH is considering the following aims and hypotheses for each trial: In schizophrenia, the overriding issue will be how these drugs affect long-term outcome: not only positive and negative symptoms, but overall level of function in multiple domains including cognition, mood, suicidality, interpersonal interactions, vocational achievement, and quality of life. In psychotic depression, the objectives are to determine the relative risks and benefits of chronic, prophylactic treatment with the atypicals. In patients with dementia, the questions have to do with acute efficacy and safety: defining which symptoms and behaviors are appropriately treated with the new antipsychotics, unique safety issues, and effects on long-term outcome. To aid in the design of a possible future solicitation, we ask that interested organizations submit comments on the following issues: 1) Are the specific aims stated above for each diagnosis (trial) the most important objectives for an NIMH sponsored trial of the new atypical antipsychotics? Are there other questions that are more compelling, and if so, what are they? 2) How needed are acute efficacy studies in psychotic depression and Alzheimer's Disease, and is this more urgent than long-term outcome data. 3) For each trial (schizophrenia, psychotic depression, and dementia), approximately how many subjects will be needed (assuming that a 10% difference in outcome is the minimum non-trivial effect) in order to reach acceptable power? How long a trial is needed? 4) How might non-pharmacological (psychosocial) interventions be handled so that interactive effects with the new antipsychotics can be accounted for (short of a randomized trial of combined psychosocial/psychopharmacological intervention)? 5) What are the appropriate control, "standard" treatments for each trial, keeping in mind the balance between the need for scientific rigor with ethical treatment of subjects. 6) How might practitioners at sites not previously involved in psychopharmacological trials, particularly those in the managed care or public setting, be involved in these trials? 7) How might the trials be more inclusive -- minimizing exclusion criteria and maximizing subject retention. NIMH welcomes responses from all individuals and organizations on each or all of these questions. Responses should be limited to approximately one (1) page per question, and are due by September 9, 1998. Sources Sought: Interest organizations should submit a capability statement of approximately 10 pages that details the ability to perform the aspects of the effort described above. All proprietary information should be marked as such. Responses will be reviewed only by NIH personnel and will be held in a confidential manner. All respondents are asked to indicate the type and size of your business organization, e.g., Large Business, Small Business, Small Disadvantaged Business, Women-Owned Business, 8(a), Historically Black College or University/Minority Institution (HBCU/MI), educational institution, profit/non-profit hospital, or other nonprofit organization, in their response. Responses should be identified with NIMH-98-RFI-01, and are due by September 9, 1998. Please submit three (3) copies of your response to the attention of: Patricia L. Gibbons, Contracting Officer, Contracts Management Branch, National Institute of Mental Health, NIH, 5600 Fishers Ln., Rm 9C-15, Rockville, MD 20857-8030. Facsimile responses will also be accepted as long as they do not exceed 20 pages in length (301-443-0501). E-mail responses, sent to pgibbons@mail.nih.gov will also be accepted. Posted 08/13/98 (W-SN236496). (0225)

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