SOLICITATION NOTICE
A -- Analgesic Clinical Trials
- Notice Date
- 5/14/2008
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541519
— Other Computer Related Services
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- 1041501
- Response Due
- 5/29/2008
- Point of Contact
- Joseph B Pishioneri,, Phone: 301-827-7109, Leonard D Grant,, Phone: (301) 827-7173
- E-Mail Address
-
joseph.pishioneri@fda.hhs.gov, leonard.grant@fda.hhs.gov
- Small Business Set-Aside
- N/A
- Description
- The Food and Drug Administration is seeking a contractor for (ACTP): Analgesic Clinical Trials Data Transformation Pilot REQUEST FOR QUOTE (RFQ). This announcement constitutes the only solicitation and a written solicitation will not be issued. Requirements: Background: The mission of the FDA Center for Drug Evaluation and Research (CDER) is to assure that safe and effective drugs are available to the American people. CDER promotes, protects and enhances the health of the public through drug development, evaluation and continued safety monitoring throughout the drug life cycle. To accomplish its mission CDER must contend with many important challenges. Failure rates in clinical development have remained largely unchanged over the past two decades. FDA’s Critical Path Initiative (CPI) seeks to identify and address scientific and technical obstacles to optimize the development of safe and therapeutically important medical products. Under the Critical Path Initiative (CPI), FDA is trying to identify innovative ways to enhance drug development and reduce the time it takes to bring therapeutically important and safer medical products to the market by leveraging prior knowledge. To this day, the only analgesic drug products that are used widely and successfully are opioids, acetaminophen and the nonsteroidal anti-inflammatory agents (NSAIDs), all of which have serious, potentially life-threatening toxicities even when used properly. While a number of products have been explorated early in the drug development process, there has been wide-spread reluctance on the part of the pharmaceutical industry to take novel products further into advanced development. This is in no small part due to the often daunting task of demonstrating the efficacy of analgesics in clinical trials. It is widely believed that the frequent failures of analgesic drug trials are due to numerous problems related to the design and analyses of these trials, including fixed-dose vs. titration-to-effect designs, choice of endpoints, high placebo response rates, frequent dropouts due to adverse events, and imputation strategies for missing data. A systematic analysis of the legacy data of pooled trial data from multiple relevant analgesic trials for treatment of acute and chronic pain is critical to guide the design of future trials, improve success rates and pursue critical research questions. This knowledge base will provide a scientific foundation for pharmaceutical developers to build upon with regard to the study and development of novel analgesic products. The FDA has accumulated the largest number of regulatory submissions of clinical trial data in the world. The Analgesic Clinical Trials Project (ACTP) seeks to analyze a large set of studies of several analgesics used to treat acute and chronic pain of varying etiologies. The results of these analyses will help to understand why some studies are less successful than others, and will be used to improve analgesic trial design. Currently, a systematic analysis of data from across various trials is difficult because the data from these studies have been submitted to the Agency in various non-standardized structures and formats. To facilitate meta-analysis across multiple studies, the legacy data that reside at FDA need to be transformed into a uniform standard structure that is compliant with the Clinical Data Interchange Standards Consortium (CDISC), Study Data Tabulation Model (SDTM). IV. Objective: FDA wishes to engage independent expert consultants to provide technical assistance in developing methodologies for data transformation of legacy data into CDISC compliant SDTM datasets and metadata. V. Scope of Work: Independently and not as an agent of the Government, the contractor shall furnish the necessary personnel, materials and services necessary for performance of the work as described below. This contract could be used for one or more analytic studies, methodology development, testing and implementation support projects, and technical assistance. The contractor will assist in the development of a standard process for organizing, standardizing, analyzing, transforming, and validating the clinical trial data. The contractor shall specify the methods it will employ in accomplishing the key tasks identified. The contractor shall demonstrate the ability to do the following: 1.Supply the infrastructure, technology, and resources to build a secure repository of clinical data using the CDISC/SDTM model 2.Map and transform the raw data (from 2-3 studies) to the CDISC/SDTM model. The technology will provide a visual design tool for building, implementing and managing data integration processes regardless of data sources, applications or platforms. 3.Provide validation and de-identification of the resulting SDTM data sets. 4.Provide integration points to allow access to other commonly used data exploration tools such as SAS JMP, JReview, and Excel. These tools will allow FDA reviewers to analyze and explore the data. VI. Relationship of Requirement to Other Contracts/Grants: Currently, there are no known contracts related to this requirement. VII. Reporting Requirements and Deliverable Items: A.General - The offeror shall submit a technical proposal that covers the type of work described in Section 5, Scope of Work. The offeror shall submit a business proposal that includes ceiling hourly rates (unloaded) for all labor categories. Proposals received will first be evaluated from a technical standpoint without regard to proposed costs. Those proposals that are considered technically acceptable will be evaluated from a financial and management standpoint. B.Technical Evaluation - This evaluation will be based upon the thoroughness of the proposal submitted. The offeror should show an understanding of the objectives and offer a logical program for their achievement. C. Deliverables: DeliverableWeeks After Start of Contract 1. Kick-off Meeting with FDAWithin 2 weeks 2. Develop Project Workplan1 month 3. Register the clinical data and documentation Within 2 months 4. Perform a metadata analysis to identify similarities, differences, and a recommendation for the process of mapping the data to SDTMWithin 3 months 5. Transform data to SDTMWithin 6 months 6. Briefing FDA at key milestones per the workplanThroughout 7. Provide access to analysis tools Within 8 months 8. Meeting with FDAWithin 8 months 9. Final reportWithin 10 months VIII. Duration of Project: Performance of this contract shall begin as early in FY 2008 as possible and shall not extend beyond one (1) year from this initiation date, unless the period is extended by amendment to this MON. XI. Evaluation Criteria: Evaluation CriteriaWeight (Total of 100 points) 1)Proposed Type of PersonnelTotal 30 points a)Offeror shall demonstrate that it employs the personnel requisite to perform high caliber qualitative and quantitative analyses over the range of studies and evaluations presented in Section 5, Scope of Work. The offeror shall name the participating personnel, identify their qualifications and experience, and for each person, indicate the percentage of time that would be devoted to this contract. On each task it is expected that at least one (1) evaluator will oversee the project who has extensive training, including a minimum of six (6) years of experience and a minimum of a master’s degree in a relevant discipline. This evaluator will be considered the key contact person for the task.Subtotal 10 points b)Offeror shall demonstrate that available personnel possess direct and recent experience with the mapping of legacy data to SDTM. Subtotal 20 points 2)Data Access and ResourcesTotal 25 points Factors to be considered include: oCapability to collect primary data and ability to work with databases of varying formats and sizes oAbility to work with both quantitative and qualitative data 3)Technical ApproachTotal 25 points Offeror shall indicate how it would staff and execute the project. The offeror shall demonstrate the ability to apply relevant elements of evaluation and statistical techniques. It shall also demonstrate expertise and methodology for developing and using best practices benchmarking to evaluate current performance and improve future outcomes. 4)Data Access and ResourcesTotal 10 points Offeror shall demonstrate primary data collection capability and the ability to work with databases of varying sizes. Ability to work with both quantitative and qualitative data shall be emphasized. 5)Project Management Total 10 points Offeror shall provide information on the administration of the project tasks. This should include management plans, methods for implementing, reviewing and effecting interim adjustments and corrections, and quality control and cost control procedures. Computer services provided must be compatible with IBM PC Systems in a Microsoft environment. XIV. Identification and Disposition of Data Offeror agrees not to disclose any such data to any persons except FDA employees having a need to know for the conduct of FDA business. REQUEST FOR QUOTE (RFQ) Any firm that believes it is capable of providing the required service as stated herein may submit a proposal to document its ability to provide the required services, which will be considered if received by the fifteenth (15th) calendar day following the appearance of this announcement. A determination to compete this procurement based on a response to this notice is solely within the discretion of the Government. All responses or questions regarding this posting must be in writing and can be sent via email to joseph.pishioneri@fda.gov. No phone calls will be accepted. This sole source procurement will be awarded as a simplified acquisition for commercial items in accordance with FAR Subpart 13.5.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=5055b927ddaba0e6aacf02dd27269ce0&tab=core&_cview=1)
- Place of Performance
- Address: New Hampshire Ave, Silver Spring, Maryland, 20993, United States
- Zip Code: 20993
- Zip Code: 20993
- Record
- SN01573419-W 20080516/080514221230-5055b927ddaba0e6aacf02dd27269ce0 (fbodaily.com)
- Source
-
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