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.