| A -- Development of the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) |
| Program Summary |
 |
| Title: |
A -- Development of the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) |
| GovCB Opps ID : |
ADP11982853390001599 |
| Document Type: |
Sources Sought Notice |
| FSC Code: |
A - Research and development
|
| Solicitation No.: |
N01-PC-85002-29 |
| Source: |
http://www1.fbo.gov/spg/HHS/NIH/RCB/N01%2DPC%2D85002%2D29/SynopsisR.html |
Posted Date:
|
Dec 21, 2007 |
| Last Update: |
Jan 15, 2008 |
| Due Date: |
Jan 25, 2008 |
|
| Description |
|
General Information
| Document Type: |
Sources Sought Notice |
| Solicitation Number: |
N01-PC-85002-29 |
| Posted Date: |
Dec 21, 2007 |
| Original Response Date: |
Jan 25, 2008 |
| Current Response Date: |
Jan 25, 2008 |
| Original Archive Date: |
Mar 31, 2008 |
| Current Archive Date: |
Mar 31, 2008 |
| Classification Code: |
A -- Research & Development |
| Naics Code: |
541720 -- Research and Development in the Social Sciences and Humanities |
Contracting Office Address
Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 6120 Executive Blvd. EPS Suite 600, Rockville, MD, 20852, UNITED STATES
Description
The National Cancer Institute, Division of Cancer Control and Population Sciences (DCCPS) is planning to award a contract for a program entitled, 'Development of the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)'. This sources sought announcement is presented in an effort to locate small businesses with the ability to perform the requirements of the program. ONLY SMALL BUSINESSES SHOULD RESPOND TO THIS ANNOUNCEMENT.
The Contractor will work with NCI program staff and with NCI-sponsored clinical trial networks to develop the Patient-Reported Outcomes version of symptom elements that are contained within the Common Terminology Criteria for Adverse Events (PRO-CTCAE). The Contractor must be able to support the development of an electronic-based and psychometrically-robust patient-reported outcome version of the symptomatic adverse events (AE) to complement the NCI Common Terminology Criteria for Adverse Events (CTCAE).
The ideal PRO-CTCAE will: 1) be comprehensive to capture a range of symptoms and functioning that enhances monitoring of adverse events; 2) have minimal burden on the patient in terms of survey length and comprehension; 3) be adaptable for translation into multiple languages to accommodate the diversity of patients who participate in NCI-sponsored clinical trials; 4) include both paper and electronic administration; 5) be fully integrated and complement the revised CTCAE (version 4.0); 6) meet the standards of compatibility within the CaBIG specifications; and 7) have minimal administrative burden for health care providers who will collect and interpret data for reporting adverse events and for informing patient care. The contract proposal will also validate the PRO-CTCAE and demonstrate the feasibility of integrating the system within NCI-sponsored trials.
It is anticipated that a resulting contract will utilize a phasing approach.
Phase I
Identify Barriers and Ideal Conditions to Develop, Implement, and Validate the PRO-CTCAE in Cancer Clinical Trials
Develop the PRO-CTCAE assessment system fully integrated with the CTCAE reporting system
Phase II (Option)
Evaluate the validity, reliability, and feasibility and clinical utility of the new PRO-CTCAE within the NCI clinical trials network.
Create Training Materials to Support the PRO-CTCAE
The NCI intends to award a cost-reimbursement contract for a one-year base period of performance on or about 9/30/2008. The contract will also contain the FAR provisions for the consideration of the optional Phase II task.
All capability statements sent in response to this SOURCES SOUGHT notice must be submitted electronically (via email) to Elizabeth B. Dean, Contract Specialist, at deane@mail.nih.gov in either MS Word, Wordperfect or Adobe Portable Document Format (PDF), by 3:00 PM EST on January 23, 2008.
Capability statements must specify the offeror's business size and type, and demonstrate similar work that has been performed in the past and the dollar value of that work. Capability statements should also clearly demonstrate the offeror's ability to fully meet the technical requirements specified above. Further, capability statements should demonstrate the offeror's comprehensive knowledge of adverse event reporting in multi-center cancer clinical trials. AT THIS TIME, ONLY CAPABILITY STATEMENTS ARE BEING REQUESTED FROM SMALL BUSINESSES. THIS ANNOUNCEMENT IS NOT A REQUEST FOR PROPOSALS. The required service is defined as code 541720 under the North American Industry Classification System (NAICS). For the purposes of this announcement, a small business is defined as one that has revenues of
Questions regarding this requirement must be submitted in writing and directed to Elizabeth Dean at deane@mail.nih.gov before the closing date of this announcement.
Point of Contact
Elizabeth Dean, Contract Specialist, Phone 301-435-3793, Fax 301-402-8579, Email deane@mail.nih.gov - Virginia DeSeau, Contracting Officer, Phone 301-435-3798, Fax 301-402-8579, Email vd9t@nih.gov
|
|
