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FBO DAILY ISSUE OF SEPTEMBER 09, 2006 FBO #1748
SOLICITATION NOTICE

A -- Quantitative Tumor Size-Survival Relationships in Oncology Clinical Trials

Notice Date

9/7/2006
 

Notice Type

Solicitation Notice
 

NAICS

541710 — Research and Development in the Physical, Engineering, and Life Sciences
 

Contracting Office

Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, MD, 20857-0001
 

ZIP Code

20857-0001
 

Solicitation Number

Reference-Number-1020531
 

Response Due

9/13/2006
 

Archive Date

9/28/2006
 

Description

THE FOOD AND DRUG ADMINISTRATION INTENDS TO AWARD THIS PURCHASE ORDER AS A SOLE SOURCE TO: JOO YEON LEE 1733 ANDERSON RD FALLS CHURCH, VA 22043. ANY INQUIRIES SHOULD BE DIRECTED TO ANGELA DASH AT 301-827-5094. Background: Reliable biomarkers of clinical outcome can streamline drug development by reducing both the time and number of patients needed to demonstrate efficacy. In oncology drug trials, tumor size assessments obtained at baseline and repeatedly during treatment are used to determine the category of best response to the drug. The primary end-point in these trials, however, is survival. The relationship between response rates and survival, particularly the ability of response rates to predict survival in these trials, remains unclear. Additionally, there is a need to evaluate quantitative measures of tumor size, including model-based analyses of longitudinal tumor size data, which may permit more sensitive predictions of survival than categorical response rates that ignore tumor kinetics. The relationship between tumor size and survival will be examined for drugs used in the treatment of lung cancer, which has become the leading cause of cancer death in men and has surpassed breast cancer as the leading cause of cancer death in women. Mortality in women due to lung cancer has increased significantly over the last century, from 3% in 1950 to 22% in 1994. This project also aims to examine sex-related differences in disease progression and response to treatment in this disease, which could be substantially beneficial to women, as well as men. Objectives: The overall objective of this project is to evaluate quantitative measures of aggregate tumor presence, both at baseline and after treatment, for their ability to predict survival in clinical trials of treatments for lung cancer. We also plan to test for any sex-related differences in the relationship between quantitative tumor measures and survival. Our goal is to quantify the impact of changes in aggregate tumor amount on patient outcome and identify any individual predictors of response. In doing so, we aim to develop analytic methodology to improve therapeutic development. This project is designed to create a standardized database of clinical information from randomized non-small cell lung cancer trials submitted to the Agency. After creating a database of survival, demographic, and tumor size data from trials of treatments for lung cancer, we will quantify relationships among patient characteristics, rates of tumor progression, and survival (treatment response). Personnel: Several individuals with diverse backgrounds will contribute to this research project. Investigators from CDER include clinical pharmacologists, pharmacometricians, statisticians and medical oncologists. As requested in this Memorandum of Need, a candidate is needed for data/information collection, database management and statistical analysis. A candidate with a MS or PhD or other equivalent training, with strong skills in statistics, modeling and database management is needed. Experience in the use of SAS, S-Plus and NONMEM is strongly desirable. Tasks and Deliverable Items: a)The Contractor shall survey NDA files and the necessary material as mentioned above to build a database across several lung cancer studies submitted to the Agency. This database will provide the knowledge base to conduct analyses to achieve the objectives of the study. b)The Contractor will access the datasets and create a repository and analyze data according to methods to be determined by the Investigators. Deliverables Timeline: Establish a repository of clinical trials in standard format - Weeks 1-8 Identify predictors of survival in clinical trials in the database - Weeks 8-46 Create a summary report of results - Weeks 46-52 Submit progress reports - Every 2 months Update database as new data are submitted - Ongoing Period of Performance: Contractor for this segment of the project is needed from Date of Award to 10-Sept-2007. Billing: The contract will be set up as an invoice. Security Requirements: The Contractor shall obtain FDA security clearance prior to beginning work. Contractor shall sign a confidentiality agreement prior to beginning work under this contract. Facilities: Contractor shall conduct research in space provided by FDA. FDA will also provide appropriate equipment.
 

Place of Performance

Address: 10903 New Hampshire Ave, Silver Spring, MD

Zip Code: 20993

Country: UNITED STATES
 

Record

SN01136112-W 20060909/060907220255 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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