National Institute of Mental Health, Contracts Management Branch, 6001 Exective Blvd., MSC 9603, Rm. 6S-6107, Bethesda, MD 20892-9603

A -- CLINICAL TRIAL COORDINATION AND DATA MANAGEMENT SUPPORT FOR NIMH SOL NIMH-00-RFI-01 DUE 081600 POC Patricia L. Gibbons (301) 443-2696 WEB: click here to view the RFI through the NIMH Home Page, http://www.nimh.nih.gov/grants/indexcon.cfm. E-MAIL: click here to contact the contracting officer via, pgibbons@mail.nih.gov. This Request for Information (RFI) 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 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, 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. Background: The NIMH is seeking clinical and data management and statistical services for multisite clinical research trials. The Division of Services and Intervention Research (DSIR) uses contracts to conduct numerous multisite clinical trials. Sometimes awards are made directly to clinical sites to carry out the research and a Contractor is needed to provide clinical coordination and data management support for those trials. Other times, an award is made to a Data and Clinical Coordinating Center who in turn subcontracts to clinical sites to carry out the research. In those cases, a wider range of services is needed. For example, DSIR's Child & Adolescent Treatment & Preventive Interventions Research Branch sponsors and directly funds small clinical trials under the Research Units in Pediatric Psychopharmacology (RUPP). Trials conducted under this network generally have from 100 to 140 subjects, take about three years to complete, and involve one to six sites. Another example is the follow-up study of the Multimodal Treatment Study of Children with Attention Deficit Hyperactivity Disorder (MTA). The MTA is a randomized clinical trial that compared the relative effectiveness of different treatments in a sample of 579 children with ADHD, aged 7-9 years. Seven clinical sites participated in the study that was conducted under an NIMH-sponsored cooperative agreement. Now, the long-term effects of these treatments will be assessed prospectively, using contracts awarded directly to the sites. Instructions: Interested organizations should submit a capability statement of approximately 10 pages that details the ability to perform the aspects of the effort described above. Specifically, the capability statement should evidence the ability to: a. establish and operate a reliable, well-monitored, efficient, secure and responsive study and data management system, for procedures to handle data typically from multicenter clinical studies and for interfacing with NIMH and study sites. b. provide statistical scientific leadership and advice in planning assigned collaborative research efforts involving NIMH-sponsored investigators such as the MTA study and for conducting and interpreting statistical analyses. c. coordinate studies: including organizational logistical aspects, monitoring clinical sites, distributing study drug, training and interactions including cultivation of commitment of participating clinical units and productive interaction among them. 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), HUBZone, 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, are due by August 16, 2000, and no later than 3:00 p.m. Eastern prevailing time. 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, 6001 Executive Blvd., Rm. 6107, MSC 9603, Bethesda, MD 20892-9603. Facsimile responses will also be accepted as long as they do not exceed 15 pages in length (301-443-0501). E-mail responses, sent to pgibbons@mail.nih.gov will also be accepted. Posted 07/21/00 (W-SN477531). (0203)

Loren Data Corp. http://www.ld.com (SYN# 0008 20000725\A-0008.SOL)

| A - Research and Development Index  |  Issue Index |