Detailed Description of Clinical Trials Database
The Premarket Approval (PMA) Clinical Trials Database is designed to improve access to information in PMA Summaries of Safety and Effectiveness data (SSEDs). When complete, the database will include the following information:
- Marketing history of the device
- Study design
- Select demographics of study participants
- Study follow-up
- Study results
Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. For additional information, please see Premarket Approval (PMA) on FDA’s Web site.
After FDA approves a PMA, it provides a summary of the safety and effectiveness data (SSED) upon which the approval is based. These are posted for each product on the Recently Approved Devices Web page. Information about approved PMAs may also be obtained from FDA's PMA Database, which is updated on a monthly basis.
The SSED contains information about the clinical studies and trials conducted in support of PMA approval. The information within the SSED follows a general template so that one can look to specific sections of the SSED for select information of interest. Nevertheless, because of the diversity of the medical device program, not all SSEDs will contain that exact same information or presentation of information. The information contained within SSEDs is provided in the form of a pdf document, which is not suitable for electronic data analysis.
The purpose of the PMA Clinical Trials Database is to create a standardized dataset of information abstracted from SSEDs about the clinical studies and trials conducted in support of PMA approval. FDA is creating this database to make the existing information in the SSEDs more accessible to patients, healthcare providers, researchers, and manufacturers. This process is part of FDA's commitment to increase transparency so that the public can gain more knowledge about the many initiatives in which FDA is engaged to protect and promote public health.
For the sample database, FDA abstracted information regarding the marketing history, source of clinical data, study design, demographics of study participants, and approval process from the PMA SSEDs. The data dictionary describes the data variables and their definitions. The sample database currently available includes information from 3 original PMAs for therapeutic devices approved from 2008-2009.
- The information in the PMA Clinical Trials database was abstracted from the SSED and does not necessarily reflect all the information available to FDA in the PMA application.
- The database identifies a number of select fields of interest to permit an individual to review this information for a range of PMAs. However, the database is not designed to provide a comprehensive presentation of the information from the SSED. As a result, for the full context of the clinical trials used to support a PMA of interest, it is recommended that the original SSED document be consulted: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm