SOURCES SOUGHT
A -- Phase I Dose-finding Pharmacokinetic Study of Phenylbutyrate
- Notice Date
- 5/7/2005
- Notice Type
- Sources Sought
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, Westat, 1650 Research Blvd., Rockville, MD, 20850
- ZIP Code
- 20850
- Solicitation Number
- WESTAT-8079-05-01
- Response Due
- 5/27/2005
- Archive Date
- 6/11/2005
- Description
- Westat, serving as the NINDS Pilot Therapeutics Network (NPTUNE) Clinical Operations Center under contract number N01-NS-4-2361 from the National Institute of Neurological Disorders and Stroke, is seeking qualified investigators and trial sites to conduct the first NPTUNE protocol - a Phase 1 dose-finding, pharmacokinetic study of phenylbutyrate in children with Spinal Muscular Atrophy (SMA). Site selection for NPTUNE?s SMA study will be a two-step process. (1) Interested investigators will first submit a statement of capability in response to this announcement. (2) Those sites whose capabilities are determined to be satisfactory will be invited to respond to a Request for Proposal. The most suitable proposals will be selected for contract negotiation and participation in the SMA study and will join the NPTUNE network. To be considered for participation in the SMA study as an investigational trial site, investigators must submit a statement of capability that demonstrates: (1) prior experience in conducting clinical research studies; (2) adequate personnel, research infrastructure, and laboratory facilities to conduct clinical trials; (3) an Institutional Review Board (IRB) with current Federal Wide Assurance (FWA) on file with the Office for Human Research Protections (OHRP); (4) facility location within the United States or Canada; (5) accessibility to and experience in treating infants and children with Spinal Muscular Atrophy. Instructions and evaluation criteria for the five-page capability statements are provided herein. Westat anticipates awarding up to ten (10) Fixed-Priced subcontracts. The performance period is projected to commence in October 2005 and take up to two (2) years to complete. BRIEF BACKGROUND The National Institute of Neurological Disorders and Stroke (NINDS) is establishing the NINDS Pilot Therapeutic Trials Network (NPTUNE) to facilitate the rapid conduct of high quality clinical trials and research through the provision of infrastructure for the design and implementation of Phase I and Phase II clinical trials in a timely and efficient manner. Westat, a contract research organization located in Rockville, Maryland, is under contract with the NINDS to serve as the Clinical Operations Center (COC) for NPTUNE. The objectives of the NPTUNE network are twofold: 1. To facilitate the early clinical testing of promising compounds for different neurological diseases. The focus will be on the timely translation of preclinical results into clinical studies and the efficient conduct of these clinical studies. Pilot clinical trials are studies required to gather the information needed to conduct a definitive efficacy study and fulfill the relevant regulatory requirements. Thus the term pilot clinical trial includes phase I and II studies. The interventions studied may be new compounds or compounds that are already FDA approved for other indications. Pilot trials include but are not limited to: a) Studies to refine the intervention strategy ? dosage, duration, delivery system, pharmacokinetics and dynamics; b) Studies to define and refine the target population; and c) Collection of preliminary data for establishing measures of efficacy and safety. 2. To build and operate a network that will serve multiple different neurological diseases through shared resources and facilitate the study of rare neurological diseases by reaching out to a large number of sites serving different patient populations. To be considered for participation as an investigational trial site for this protocol, investigators must demonstrate: 1) Prior experience in conducting clinical research studies; 2) Adequate personnel and facilities necessary to conduct clinical trials; 3) Institutional Review Board (IRB) with current Federal Wide Assurance (FWA) on file with the Office for Human Research Protections (OHRP); 4) Facility location within the United States or Canada; and 5) Accessibility to and experience in treating infants and children with SMA. Applicant institutions are requested to complete and submit a Capability Statement form included with this RFC and return it to the address listed on the form. Capability Statements are due no later than 5:00 p.m. U.S. Eastern Time on May 27, 2005. Capability Statements must be received by the due date to allow adequate time for staff preparation and for the objective review process. Please carefully follow the instructions below, and make sure the Capability Statement is easy to read. The text of the Capability Statement should be no longer than five (5) pages in length (one-and-a-half line spacing and an 11-point font). Appendices with additional background information may be included and do not count as part of the 5-page limit. A Capability Statement received after the due date may be considered at Westat?s discretion. 1. NPTUNE INVESTIGATIVE SITE CAPABILITY STATEMENT FORM (format) Complete the NPTUNE Investigator Site Capability Statement Form (Attachment 1) using Microsoft Word or other word processing software. The statement may also be submitted without using this form as long as the contents appear in the same order as found in the form. 2. CURRICULUM VITAE Please provide a dated curriculum vitae, current to within one year, for the principal investigator (PI), in either the individual's own format or in an abbreviated, four-page NIH bio-sketch form (PHS 398/2590 (Rev. 09/04)). If there is a study coordinator in addition to the PI, please send a dated and current (within one year) curriculum vitae for that person as well. The NIH form can be found at http://grants.nih.gov/grants/funding/2590/biosketch.doc. 3. TECHNICAL EVALUATION CRITERIA Statements for this initiative will be evaluated based upon complete documentation provided in response to this RFC. Sites under consideration for participation in this first protocol will be evaluated based on the following criteria: A. Recruitment Potential and Follow-Up Capability of clinical center/hospital to recruit, treat and follow infants and children with SMA for participation in this trial. Plan to retain study participants and assure compliance of study participants with protocol requirements. Plan should include a specific description of steps to ensure protocol adherence and retention. B. Previous Research Experience of Site/Staff Experience of proposed staff in the conduct of pharmacologic clinical research studies. Assurance that highly qualified key personnel are designated and available to participate in this trial, including availability of the Principal Investigator (PI) and/or study coordinator to complete required documentation. C. Research Infrastructure and Laboratory Facilities Availability of appropriate facilities, space, and laboratories to conduct a clinical research study or studies, including overall description of research facilities. ADMINISTRATIVE INFORMATION 1. Principal Investigator:Provide name, title, address, telephone, FAX and e-mail address of the Principal Investigator(s) who will be responsible for execution of this trial. Submit a CV or an NIH Biosketch. 2.Institution: Provide full legal name and address of the Institution being considered for qualification, including name, title, telephone, FAX and e-mail address of the business officer authorized to receive payment under this subcontract in the event of an award. Provide information for any and all other institutions for which this proposal is being submitted. 3. Name and Address of Institutional Review Board (IRB) 4. Federal-Wide Assurance (FWA) number and date of expiration PARTICIPANT RECRUITMENT AND RETENTION 5.Recruitment: Describe neurology population resources, numbers of participants followed. Use a table to illustrate numbers and comments on specific areas of the practice. Adults are 18 yrs or older. Overall Neurology Practice: Ataxic Disorders Disorders of the Autonomic Nervous System Movement Disorders Neuromuscular Disorders Other Spinal Muscular Atrophy Type 1 (up to 2 years) Type 2 (>2 to 6 years) Type 3 (>6 to 12 years) Comments 6.Retention Describe how your site plans to recruit and retain study participants and ensure protocol adherence. RESEARCH EXPERIENCE AND INFRASTRUCTURE 7. Previous and Current Research Experience A. Describe previous experience with pharmacologic clinical trials. The applicant may specify the name and sponsor of the trials, the primary objectives, the numbers participants enrolled at your site, length of study, and any publications or findings. B. Describe staff experience in conducting clinical trials; i.e., the principal investigator, clinical research coordinator, data manager, investigational pharmacist, physical therapist and others. C. Describe the clinical trials and research studies, currently being conducted, which are enrolling this target population and/or which are utilizing the same staff or facilities as would be used for this study. 8. Practice Type, Staff, Facilities, and Infrastructure A. Describe the type of neurology practice, including any specialties. B. Describe the professional and support staff available at your facility. C. Provide a general description of your research facilities. If more than one research site exists, list each research site and describe how the sites implement clinical trials and collaborate with each other. 9. Clinical Laboratory Facilities and Capabilities A. Describe your clinical laboratory facilities and capabilities. B. Provide information on date and type of accreditation of clinical laboratory. C. Describe staff expertise and established methods for processing, storing and transporting research study/trial specimens.
- Place of Performance
- Address: various
- Record
- SN00802886-W 20050509/050507211623 (fbodaily.com)
- Source
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