NOTE – this synopsis follows a
Sources Sought notice that was released on December 21, 2007 under RFP
#N01-PC-85002-29.

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)'.   The required service is defined as code 541720
under the North American Industry Classification System
(NAICS).    

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 resulting 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 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.   
The Government intends to have a full & open competition for this
requirement in the form of a Request for Proposal (RFP).  This synopsis is not an RFP; an RFP is
anticipated for release on or about April 21, 2008 through Federal Business
Opportunities.   

Questions regarding this requirement must be submitted in writing and directed
to Elizabeth Dean at deane@mail.nih.gov.  The reference number to be used for this
announcement is RFP N02-PC-85002-29.  All
correspondence must cite the reference number as provided.