SOLICITATION NOTICE
R -- ClinicalTrials Results Database
- Notice Date
- 9/12/2007
- 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
- 07-214-CYC
- Response Due
- 9/27/2007
- Archive Date
- 10/12/2007
- Description
- It is the intent of the National Library of Medicine (NLM) to procure professional services from Dr. Mark Helfand on a sole source basis. Professional services of a person with expertise in systematic reviews, reporting of clinical trial results by drug companies and display of evidence-based reviews to the public are required over a 12-month period to assist in the development and validation of a database to organize and to archive the key results of clinical trials. Proposed Work The purpose of this procurement is to obtain expert evaluation of the data elements and data entry system for results reporting, The task will require the Contractor to: (1) Evaluate the appropriateness of proposed results data elements using experience gained by analyzing industry-sponsored results databases; (2) Review each results database field and determine the optimal balance between structure and breadth; (3) Investigate different methods an approached for collecting and entering results data across different types of clinical trials via a pilot study to provide maximum utility to scientists, health providers and the public; (4) Recommend revisions to the data entry system based on the outcome of a pilot study; and (5) Evaluate the display of a clinical trail result technical summary. Dr. Helfand has reviewed the results offerings of 14 industry results databases and identified examples of both high and poor quality reporting practices as well as biased reporting. This work would be invaluable for this project, ans the expertise gained from his work will inform the NIH effort on best practices of stat-of-the-art results reporting databases while avoiding the pitfalls of over and under reporting and biased reporting. Dr. Helfand is a nationally regarded methodologist and leader in the use of evidence-based medicine, systematic reviews, and meta-analyses in the public policy setting. Thus, Dr. Helfand is uniquely qualified to review and evaluate mechanisms for collecting, reporting and displaying clinical trials results at publicly accessible databases, such as a new database implemented by ClinicalTrials.gov, designed to inform members of the public and professionals. 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) (August 2007). 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 07-214/CYC. Inquires regarding this procurement may be made to Cara Y. Calimano, Contract Specialist, NLM on (301) 496-6546.
- Place of Performance
- Address: 8600 Rockville Pike, Bethesda, MD
- Zip Code: 20894
- Country: UNITED STATES
- Zip Code: 20894
- Record
- SN01403807-W 20070914/070913072107 (fbodaily.com)
- Source
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