MODIFICATION
D -- Developing and Implementing an Effective electronic Protocol Authoring (ePA) system
- Notice Date
- 1/13/2011
- Notice Type
- Modification/Amendment
- NAICS
- 541519
— Other Computer Related Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, Science Applications International Corporation (SAIC), 92 Thomas Johnson Drive, Suite 250, Frederick, Maryland, 21702
- ZIP Code
- 21702
- Solicitation Number
- S11-080
- Point of Contact
- Calvin H. Proffitt, Phone: 3012284008, Jennifer Thomas, Phone: 301-228-4004
- E-Mail Address
-
proffittch@mail.nih.gov, thomasjennifer@mail.nih.gov
(proffittch@mail.nih.gov, thomasjennifer@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- RFI for Developing and Implementing an Effective electronic Protocol Authoring (ePA) system This RFI is issued by SAIC-Frederick General Information: This request for information (RFI) is for informational and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of SAIC-Frederick, Inc. (SAIC-F). The intent of this RFI is to gather market research. Information gleaned may result in a formal Request for Proposal. Any questions or communications pertaining to this RFI shall only be directed to the SAIC-F Subcontract Specialist. Questions or requests directed to any other individual will not be considered valid, nor will there be a response provided. SAIC-F Subcontract Specialist: Calvin Proffitt SAIC-Frederick, Inc. 92 Thomas Johnson Drive, Suite 250 Frederick, MD 21702 proffittch@mail.nih.gov 301-228-4008 Important Dates to Remember: Questions regarding this RFI shall be emailed to the Subcontract Specialist by 2:00 p.m. Eastern Time on December 27, 2010. Responses to this RFI are due to the Subcontract Specialist by 2:00 p.m. Eastern Time on January 24, 2011. Information Requested: SAIC-F welcomes your input and comments on an ePA tool/process. We would particularly like your opinions on how to develop and implement an effective ePA system using COTS products. Please bear in mind that the overarching framework for the ePA "application" is that it will be composed of a number of business capability services, associated process services, and bound to an underlying semantic infrastructure and should therefore not be viewed as a "traditional, monolithic application." Response Instructions Organizations wishing to respond to this request for information are asked to do so using the attached Response Q&A Template. This attachment includes specific questions that SAIC-F would like organizations to address. Purpose of RFI: SAIC-Frederick, Inc. (SAIC-F) would like to obtain market information regarding the feasibility of developing a process leveraging commercially available software applications to support the development and management of protocol documents for National Cancer Institute (NCI) supported clinical trials. SAIC-F would like to understand the market availability, functional and technical solutions, and Commercial Off-The-Shelf (COTS) products and services capable of satisfying the National Cancer Institute (NCI) business, functional, technical, and operational characteristics of electronic Protocol Authoring as described in this RFI. Although titled electronic Protocol Authoring (ePA), the project includes all facets of the protocol development lifecycle including, but not limited to, drafting, authoring, reviewing, modifying, tracking, and managing Letters of Intent (LOI), concepts, protocols, amendments, and other materials associated with NCI clinical trials. The Cancer Therapy Evaluation Program (CTEP), within the NCI's Division of Cancer Treatment and Diagnosis (DCTD), is responsible for coordinating the largest publicly-funded oncology clinical trials organization in the world (http://ctep.cancer.gov/). The CTEP portfolio includes 900 active trials enrolling 30,000 study participants annually, nearly 400 grants and cooperative agreements, and about 100 investigational new drugs (INDs). CTEP sponsored research spans phase 1 through phase 3 trials in all cancers and treatment modalities -- chemotherapy, immunotherapy, radiation and surgery. A large portion of CTEP's research portfolio is coordinated through the NCI Clinical Trials Cooperative Group Program. The Clinical Trials Cooperative Group Program (http://www.cancer.gov/cancertopics/factsheet/NCI/clinical-trials-cooperative-group) is designed to promote and support clinical trials (research studies) of new cancer treatments, explore methods of cancer prevention and early detection, and study quality of life issues and rehabilitation during and after treatment. Cooperative Groups include researchers, cancer centers, and community physicians throughout the United States, Canada, and Europe. They work with the NCI to identify important questions in cancer research and to design clinical trials to answer these questions. The Cooperative Group Program involves more than 3,100 institutions that register or enroll patients to Group conducted clinical trials. More than 14,000 individual investigators are registered to participate in NCI supported Cooperative Group studies. Cooperative Groups place more than 25,000 new patients into cancer treatment clinical trials each year. The scientific intent and process of a clinical trial is detailed through a research protocol. The protocol describes the research purpose and methodology. Protocol documents also contain safety, regulatory, pharmaceutical, administrative and operational information related to the conduct of the trial. Potential protocols are initially developed and reviewed locally, as pre-protocols (i.e., LOIs or concepts) at Universities, Cancer Centers and Cooperative Groups. LOIs or concepts (http://ctep.cancer.gov/protocolDevelopment/default.htm#lois_concepts) that are approved locally are then forwarded to the NCI for review and approval. NCI approved LOIs and concepts are returned to investigators for development into full fledged protocols which undergo a series of contributions and reviews both locally and at the NCI to optimize the trial's scientific and safety profile and ensure all safety, regulatory, administrative, and operational components are accurate and complete. Once finalized, the protocol is distributed as a PDF document by the Groups to investigators at participating sites via the Web. Interested investigators forward the protocol to local Institutional Review Boards (IRB) prior to enrolling patients on the trial. Over the life of a trial, protocols will need to be amended periodically to address evolving scientific, safety, regulatory, and/or administrative changes. In December 2008, the Operational Efficiency Working Group (OEWG) was established under auspices of the Clinical Trials and Translational Research Advisory Committee (CTAC) to advise the NCI on strategies to reduce the time required to activate NCI sponsored Cooperative Group and early drug development protocols (http://ccct.cancer.gov/files/OEWG-Report.pdf). The OEWG is a broadly constituted panel with representation throughout the oncology community. The OEWG set target dates for the development of protocols based on trial phase. One of the key OEWG recommendations to improve the efficiency of the protocol development lifecycle is to ‘Develop a coordinated approach to standardization of protocol elements and protocol development tools involving NCI, the Cooperative Groups, and the Cancer Centers in order to speed development and review of protocols.' The ePA initiative is intended to address the OEWG recommendations through identification of secured and standardized tools, content libraries, and processes to facilitate the rapid and efficient development of protocol documents for CTEP treatment trials. A small working group with NCI and Cooperative Group representation has been formed to identify best practices and requirements. The initial impression by the group is that a fully integrated ePA tool(s)/processes would provide the best solution. Integrated ePA applications and processes would support protocol authoring and development using: standard libraries and templates; multi-stage collaborative review with expert and novice users; workflow management, scheduling, communication and tracking to ensure protocols reach target timelines; and collection and sharing of metadata (e.g., milestones and protocol descriptors) to eliminate redundant sequential document abstraction. This would all be packaged in a user friendly web-based PC/Mac and multi-browser compatible application that shall be compliant with Federal regulations (i.e. 508 compliance) and can take advantage of a federated single sign on process. This RFI seeks to determine if there is a single electronic solution to support the ePA process. In the likely event that a single solution is not available then the question is what integrated tools and processes could be packaged together to provide an integrated solution. It is envisioned that the software product and approach identified through this RFI could be used to promote the efficient development of protocols in other NCI programs (e.g., diagnosis, prevention, cancer control, epidemiology). In the future the ePA tools could potentially be tailored to support protocol development in non-oncology (e.g., cardiovascular, diabetes, infectious diseases) arenas.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/contractor/S11-080/listing.html)
- Place of Performance
- Address: N/A, United States
- Record
- SN02359411-W 20110115/110113234103-5f22c573246aaa6cd046ef43766b3046 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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