Added: Jun 30, 2008 4:42 pm
Modified: Jul 25, 2008 1:53 pm
Track Changes
The Food and Drug Administration (FDA) is seeking proposals for a contractor to fulfill a requirement for a program titled: Scientific Program to Support Epidemiologic Investigations of Safety Released Issues of Marketed Drugs, and Evaluations of Risk Management Programs and Tools.
The primary objectives to be accomplished under these contracts are to provide FDA with: 1) Conduct drug safety analyses of importance to FDA using both retrospective and prospective methods, as appropriate; 2) Establish a collaborative arrangement with existing pharmacoepidemiologic research programs for the purpose of conducting epidemiologic studies of drug safety issues using databases containing electronic health information; 3) Establish a collaborative arrangement with existing pharmacoepidemiologic research programs for the purpose of evaluating the effectiveness of risk management programs and tools using databases containing electronic health information; 4) Obtain technical assistance or consultative support on methods and the use of electronic healthcare data resources for conducting pharmacoepidemiologic research, and; 5) Enable timely access to US and Canadian population-based data sources to ensure public safety when necessary.
Data Requirements: Successful Contractors will have continuous access to an updated electronic healthcare data resource containing patient-level health encounter data from the U.S. or Canada. The data resource shall be a computerized system able to link each patient to all relevant medical care data including enrollment status, drug exposure data, and coded medical outcomes. This data resource will meet the criteria specified in the minimum mandatory criteria throughout the length of the contract. Linkage of this data resource to additional information, including vital records, chronic disease and/or cancer registries, and birth defect registries, if available, is also of interest. It shall be solely the Contractor s responsibility to insure that the data are HIPAA-compliant, and to de-identify the data for FDA use. FDA will require no patient-, provider-, or health plan-specific identifiers. All research performed by the FDA PRP centers must comply with standards for privacy of individually identifiable health information and protect the rights of human subjects in research.
For the purpose of this requirement, the data resource shall be sufficient to meet FDA s need to access patient-level data describing health encounters and prescription drug use by individuals over time. The data resource shall have longitudinal data that shall be capable of following uniquely identifiable individuals (using encrypted patient identifiers) over time. Demographic information (e.g. age and gender), health history, diagnoses and procedures, and hospitalizations shall be provided. Information on race/ethnicity shall be included, if available, accompanied by documentation of the origin of this information. The data resource shall also have the ability to identify pregnancies and pregnancy outcomes as well as have the ability to subsequently link maternal and child records after birth.
In addition, for each patient these data shall contain prescription drug and biologic utilization information, including the generic and brand name of the product, strength, dosage form, days supply, all dates dispensed, initial/continuing therapy indicator, quantity dispensed, instructions for use (if available), indication for use (if available) and prescriber specialty. The resource shall employ the use of a generally accepted, granular coding system for drugs and medical products, as well as for diagnoses and procedures. In addition, the contractor shall have the ability to determine that the drug or biologic was dispensed to the patient, rather than just prescribed to the patient.
All patient medical diagnostic information shall be represented in the data resource, including diagnoses and procedures associated with all ambulatory, emergency, chronic or acute care setting visits and their dates, diagnoses and procedures associated with all related hospitalizations and their dates, and all laboratory tests and results (if available) and their dates. Other health measures (such as family health history, height, weight, body mass index, smoking status, alcohol use, blood pressure measurements, etc.), are of interest if available. The successful Contractors shall have the capability of accessing inpatient medical records for validating coded diagnostic data; access to outpatient medical records is also of interest if available.
The ability to contact a sample of physicians and/or a sample of patients/caregivers on an ad hoc basis for information beyond what is available in the data source (e.g., survey to determine reasons for prescribing decisions, use of informed consent, use of nonprescription drugs and/or medical products, comprehension of consumer medication information) is also of interest.
FDA intends to solicit this requirement as a full and open competitive requirement.
The solicitation will be available for download on or about August 26, 2008 and may be accessed through the Federal Business Opportunities (FedBizOpps) website. No hardcopies will be distributed. Any questions concerning this requirement must be submitted in writing by e-mail only, to Patricia Wright at patricia.wright@fda.hhs.gov. NO PHONES WILL BE ACCEPTED. All responsible sources may submit a proposal which will be considered by the Agency.
