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FBO DAILY ISSUE OF SEPTEMBER 02, 2004 FBO #1011
SOLICITATION NOTICE

R -- Practical Outcomes Monitoring and Evaluation System (POMES) in a Homeopathic Clinic in Calcutta, India

Notice Date
8/31/2004
 
Notice Type
Solicitation Notice
 
NAICS
621498 — All Other Outpatient Care Centers
 
Contracting Office
Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Research Contracts Br., 6120 Executive Blvd. EPS Suite 600, Rockville, MD, 20852
 
ZIP Code
20852
 
Solicitation Number
N02-CO-47039-48
 
Response Due
10/15/2004
 
Archive Date
10/30/2004
 
Point of Contact
John Manouelian, Contract Specialist, Phone (301) 435-3813, Fax (301) 402-6699, - Richard Hartmann, Contracting Officer, Phone (301) 496-8620, Fax (301) 402-6699,
 
E-Mail Address
jm486p@nih.gov, rh75f@nih.gov
 
Description
The Office of Cancer Complementary and Alternative Medicine (OCCAM) of the National Cancer Institute (NCI) at the National Institutes of Health (NIH) has a new requirement for conducting a study to assess the outcomes of a group of lung cancer patients treated with homeopathic therapy in a clinic in Calcutta, India. Specifically, the OCCAM will support a prospective observational outcome study of newly diagnosed lung cancer patients in this particular homeopathy clinic. The purpose of this contract is: 1) to document the number of new lung cancer patients seen in the clinic; 2) to identify each patient and determine their eligibility for the outcomes monitoring protocol (protocol will be provided by the OCCAM); 3) to follow 30 of the eligible patients for 2 years after enrollment into the study to assess tumor response, patient survival and quality of life; and 4) to document the homeopathic therapies received by the study participants. In order to accomplish the aims of this project, the OCCAM will seek Contractors having both expertise in clinical and cancer research, as well as affiliated offices or workforce in India (preferably in Calcutta or with easy means of access, to enable prompt and accurate accomplishments of all contract requirements). Primary protocol objectives include: 1) Identifying eligible lung cancer patients to participate in the study; and 2) Following up study cohort as per protocol to determine the response rate of tumors detectable by radiography [Chest Computed Tomography Scans (CT scans)] in eligible lung cancer patients entered on this protocol through the P. Banerji Homeopathic Research (PBHRF) clinics. Secondary protocol objectives include: 1) Progression-free survival of patients; 2) Overall survival of patients; and 3) Assessing changes in patient quality of life after starting therapy through the PBHRF clinics as well as changes in disease-related symptoms (e.g., chest pain, cough, hemoptysis, fatigue, weight loss, etc.) via administration of a validated quality of life assessment tool. Additional protocol objectives include reviewing charts of additional cases of cancer remissions occurring in patients receiving homeopathic therapy (these cases will be identified on a case by case method as per request of the NCI Project Officer). An optional supplemental cancer protocol(s) on other types of cancers (e.g., esophageal cancer) may be required to be carried out after the satisfactory completion of the accrual to the lung cancer protocol. The decision to proceed with the implementation of the supplemental protocol(s) will be made by the NCI Project Officer during the first year of the lung cancer study. In order to effect this supplemental work, the contract document will be written to include option provisions for each year of the contract. This is a new requirement and the Request For Proposal (RFP) No. N02-CO-47019 will issued on or about September 15, 2004. The RFP will be available at the website of the Research Contracts Branch, NCI (http://rcb.cancer.gov/rcb-internet/). The Government anticipates one contract will be awarded on an incrementally funded basis for a period of three years with optional studies that will run concurrently with the base requirements. The NAICS Code is 621498. No Collect Calls will be accepted.
 
Place of Performance
Address: P. Banerji Homeopathic Research Foundation (PBHRF), 10/3/1 Elgin Road, Calcutta, India
Country: India
 
Record
SN00662005-W 20040902/040901034601 (fbodaily.com)
 
Source
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)

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