SOLICITATION NOTICE
A -- Clinical Trial of Topical Thalidomide for Aphthous Stomatitis in Patients with HIV/AIDS
- Notice Date
- 10/20/2003
- Notice Type
- Solicitation Notice
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung, and Blood Institute, Contracts Operations Branch 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, MD, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- NIH-NIDCR-DR-04-15
- Response Due
- 1/30/2004
- Archive Date
- 2/14/2004
- Point of Contact
- Richard Phillips, Contract Specialist, Phone 301-435-6671, Fax 301-480-3432, - Patricia Davis, Chief, BDR Section, Phone (301) 435-0355, Fax (301) 480-3432,
- E-Mail Address
-
rp235k@nih.gov, pd15j@nih.gov
- Small Business Set-Aside
- Total Small Business
- Description
- The National Heart, Lung, and Blood Institute (NHLBI) serves as a service center to the National Institute of Dental and Craniofacial Research (NIDCR) for research and development contracts. The NIDCR has a requirement for a study to assess the efficacy and safety of a novel topical thalidomide formulation for healing of aphthous ulcers associated with HIV/AIDS in a Phase II/III clinical trial of 160 subjects. The proposed procurement is under a 100 percent small business set-aside, and the NAICS code is 541710. The successful offeror will operate as a Coordinating Center for this clinical trial. The Coordinating Center shall be capable of conducting all aspects of a multi-center clinical trial for the treatment of aphthous stomatitis in patients with HIV/AIDS using a topical formulation of thalidomide and will be responsible for performing the following tasks: 1) Identify up to 10 clinical sites capable of recruiting study subjects 18 years of age or older with HIV infection or AIDS who are experiencing painful oral lesions. Clinical sites identified must be capable of recruiting approximately 10 - 12 patients per year for up to two years, with each subject evaluated weekly and followed up to four weeks beyond study entry. 2) Issue Request For Proposals (RFPs) for subcontracts with clinical sites by the end of the 3rd contract month and complete site selection by the end of 6th contract month. 3) Using the existing NIDCR protocol, which has been approved by the FDA, and in collaboration with the Government Project Officer, develop, disseminate and revise, as needed, Standard Operating Procedures. 4) Randomize patients and coordinate with the NIH pharmacy, drug dissemination to the clinical sites and maintain appropriate control records. Note: The government (NIH) holds the IND for the test article (drug) and will supply the drug for the study. 5) Assist clinical sites in obtaining and maintaining IRB approval, as well as track protocol violations. 6) Establish a data management plan and possess a computer data storage system that will receive, inventory, and store all information. 7) Perform data analyses of all study data. 8) Comply with DHHS Automated Information Systems Security Program (AISSP) Handbook found at this location: http://irm.cit.nih.gov/policy/aissp.html The government intends to negotiate one cost reimbursement type contract for a period of four years with an approximate award date of August 31, 2004. This is not a Request For Proposals. RFP NIDCR-DR-04-15 will be available on or about November 4, 2003 and may be accessed at the following URL location: http://www.nhlbi.nih.gov/funding/inits/index.htm#rfp and posted on Fed Biz Opps at http://fedbizopps.gov No paper copies will be available. Original Point of Contract Rick Phillips, Contract Specialist, Phone (301) 435-6671, Fax (301) 480-3432, E-mail phillipr@nhlbi.nih.gov or Patricia Davis, Chief, BDR Contract Section, Phone (301) 435-0355, Fax (301) 480-3432, E-mail pd15j@nih.gov
- Record
- SN00454628-W 20031022/031020213235 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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