SOURCES SOUGHT
A -- Pediatric Off-Patent Drug Study (PODS) Center-Sodium Nitroprusside
- Notice Date
- 6/18/2003
- Notice Type
- Sources Sought
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Child Health and Human Development, Contracts Management Branch 6100 Executive Blvd., Suite 7A07, MSC7510, Bethesda, MD, 20892-7510
- ZIP Code
- 20892-7510
- Solicitation Number
- NICHD-2003-09SS
- Response Due
- 7/10/2003
- Archive Date
- 7/25/2003
- Point of Contact
- Mya Hlaing, Contracting Officer, Phone 301-435-6958, Fax 301-402-3676, - James Quinn, Chief, Contracts Management Branch, Phone 301-435-6964, Fax 301-402-3676,
- E-Mail Address
-
mh89m@nih.gov, quinnja@mail.nih.gov
- Description
- The National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), is seeking sources capable of conducting clinical trials on the use of sodium nitroprusside to maintain controlled hypotension in pediatric patients undergoing surgical procedures. It is expected that these studies will involve multiple sites. Established pediatric drug trials networks or offerors that include multiple sites are encouraged to respond. Sodium nitroprusside is commonly used for maintaining periods of hypotension during pediatric surgical procedures. However, there is limited information available about dosing, pharmacokinetics, effectiveness and safety in pediatric patients who are maintained in states of controlled hypotension for either short or long periods. The NICHD plans to conduct studies of safety, pharmacokinetic and pharmacodynamic relationships, and dosing in pediatric patients requiring periods of controlled hypotension using randomized, observer-blinded approaches. Investigators will recruit a broad spectrum of patients who require periods of controlled hypotension. It is anticipated that 200 patients will be required to complete the studies. Interested organizations shall provide a brief statement of capabilities not to exceed 10 pages that includes past experience in conducting clinical drug trials in pediatric populations and access to and ability to recruit the necessary patient population, that is, children undergoing surgical procedures in which hypotension is induced and maintained by an infusion of sodium nitroprusside. Also include qualifications and experience of the proposed personnel in the conduct of similar types of clinical research; evidence of previous experience in similar pediatric clinical trials, including clinical trials requiring a Data and Safety Monitoring Board, and studies leading to pediatric labeling; numbers of patients enrolled and retained in pediatric clinical trials (past and present); procedures and mechanisms for facilitating referral and enrollment of pediatric patients undergoing periods of controlled hypotension; access to target populations (newborns, toddlers; preschool children; school-age children; and adolescents requiring periods of controlled hypotension) demonstrated by recruitment in previous clinical trials or current clinical populations; access to ethnic and racial minority pediatric populations requiring controlled hypotension; evidence of number of patients requiring controlled hypotension that will be available to receive infusions of sodium nitropruside. Also provide documentation of all clinical and laboratory facilities and equipment; clinic and clinical trials site space description; pharmacy capability, i.e., storage area, staff availability, and quality control plan. Please send original plus four copies of your capabilities statement to: Mrs. Mya N. Hlaing, Contracting Officer, NICHD, CMB, 6100 Building, Suite 7A-07, 6100 EXECUTIVE Blvd., MSC 7510, Bethesda, Maryland 20892-7510 (if sending by overnight carrier, use 6100 Executive Blvd., Suite 7A-07, Rockville, Maryland 20852) on or before July 10, 2003. Fully electronic copies will not be accepted. The referenced number to use for this announcement is: NICHD-2003-09. All correspondence must cite the referenced number as provided.
- Record
- SN00350365-W 20030620/030618213324 (fbodaily.com)
- Source
-
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