SOLICITATION NOTICE
R -- Improving the Quality of Online Data at ClinicalTrials.gov
- Notice Date
- 4/9/2007
- Notice Type
- Solicitation Notice
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Library of Medicine, 8600 Rockville Pike, Bethesda, MD, 20894, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- 07-086-CYC
- Response Due
- 4/24/2007
- Archive Date
- 5/9/2007
- Description
- It is the intent of the National Library of Medicine (NLM) to procure professional services from Joseph Lau, Natick, Massachusetts on a sole source basis. A person with expertise in systematic reviews, evidence-based medicine, meta-analysis etc. are required over a six (6) month period to assist in the development and validation of a database to organize and to archive the results of NIH-sponsored clinical trials. Proposed Work: The purpose of this procurement is to obtain expert evaluation of the ClinicalTrails.gov data elements for results reporting and their utility. The task will require the reviewer to: (1) Evaluate the appropriateness of proposed ClinicalTrails.gov results structure, including the data elements and their definitions; (2) Review each field for specific attributes (e.g., query structure, quality of responses, display of information); (3) Investigate other methods and approaches for collecting and presenting results data to provide maximum utility to scientists, health providers and the public; (4) Evaluate the pros and cons of possible revisions based on the results of pilot studies of completed NIH-supported clinical trials; and (5) Synthesize the findings into recommendations for possible implementation in ClinicalTrails.gov. Required Tasks: The following tasks are to be completed. All data will be provided in electronic format. The Contractor shall conduct the work off-site using her/his own hardware and software. Task Description: The professional services to be performed consist of the delivery of hours in support of the following tasks: (1) Identify and organize the data collection and information display needs of lay and professional audiences based on current evidence reported in the medical literature and utility to practitioners of evidence-based methods; (2) Review and evaluate the proposed set of data elements ans data element definitions in light of the needs identified above; (3) Review and evaluate the implementation of the data elements both in terms of data and data display (ClinicalTrials.gov), including logical grouping of fields and other form design/layout issues, appropriateness and usefulness of the information such as labeling/wording, and use of controlled vocabularies to structure the data; (4) Perform an analysis of data extraction forms/methods reported in the scholarly literature and by professional groups (e.g., Tufts-New England Medical Center Evidence-based Practice Center (EPC); Oregon EPC; the Consolidated Standards of Reporting Trials (CONSORT) statement; the evidence-based medicine GRADE approach; Ottawa Statement; Cochrane Collaboration); (5) Identify additional data elements that should be included in the results database; (6) Meet either by phone/person to discuss final database plans; and (7) Consult with staff during implementation of pilot study. Joseph Lau, MD is a tenured academic (Professor of Medicine/Clinical Research) at the Sackler School of Graduate Biomedical Sciences, Tufts University; a clinical-investigator at the Division of Clinical Care Research at Tufts-New England Medical Center; Co-Director of the has US Cochrane Center, Boston Branch; and the Director of the Center for Clinical Evidence Synthesis, also at the Tufts-New England Medical Center, one of 12 Agency for Healthcare Research and Quality (AHRQ) - designated Evidence-based Practice Centers (EPCs). Dr. Lau is a leader in methodological issues of evidence synthesis and known internationally for his work in the field of meta-analysis and its implications. He conducts research to develop reliable and efficient methods and tools to conduct meta-analyses and in understanding the impact of factors that may contribute to differences of results in clinical studies. His research has included topics such as cumulative meta-analyses of small trials, effect of baseline risk in the interpretation clinical trail results, and empirical evaluation of existing methods of combining data. Dr. Lau has published numerous peer-reviewed articles, reviews, and clinical practice guidelines, and is active in a number of international, national, and local organizations, including professional societies, committees, and editorial boards. He currently holds four HHS grants, including one from the National Center for Research Resources (NCRR) to develop a system to bring together various computer programs and procedure developed for meta-analysis .He is uniquely qualified to review and evaluate the data elements and their implementations in ClinicalTrials.gov and the PRS practitioners of evidence-based methods as well as patients and other members of the public. The proposed acquisition will be procured under FAR Part 13 - Acquisitions of Non-Commercial Items. This is not a Request for Quotations (RFQ), nor is an RFQ available. Full text of clauses and provisions are available at Federal Acquisition Regulation (FAR): http://www.arnet.gov/far/index.html. The following clauses and provisions apply to this acquisition and may be obtained from the web site: FAR 52.213-4, Terms and Conditions?Simplified Acquisitions (Other Than Commercial Items) (September 2006). However, all responsive sources may submit a capabilities statement in a timely manner that will be considered by the Government. Proposals must include pricing information. Responses must be in writing and must be received in the office within fifteen (15) business days from the publication date of this notice. EMAIL OR FAXED PROPOSALS WILL NOT BE ACCEPTED. NLM Synopsis No. NLM 07-086/CYC. Inquires regarding this procurement may be made to Cara Y. Calimano, Contract Specialist, NLM on (301) 496-6127.
- Place of Performance
- Address: 8600 Rockville Pike, Bethesda, Maryland
- Zip Code: 20894
- Country: UNITED STATES
- Zip Code: 20894
- Record
- SN01269188-W 20070411/070409220219 (fbodaily.com)
- Source
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