Experts and stakeholders gathered at the December 16th workshop sponsored by FDA and the eHealth Initiative Foundation to discuss the current status of the Sentinel Initiative. Currently the FDA is working with public academic and private entities to find ways to access disparate sources of data and to validate methods to link and analyze safety data from multiple sources. The vision is to develop a nation-wide electronic safety monitoring system to be able to monitor postmarket performance of a product.
According to the goals of the project, it is important to pinpoint the data that is needed, find methods to consistently aggregate the data, along with methods to perform an effective statistical analysis. Standard processes will also be needed that can be applied against multiple and different data environments.
According to Janet Woodcock, M.D., Director, FDA Center for Drug Evaluation and Research, “governance” is a key issue under discussion. Governance means defining responsibilities for implementing policies and procedures for administering certain aspects of the initiative such as scientific operations and infrastructure along with designing the capabilities needed.
Mark McClellan, M.D., PhD, Director Engelberg Center for Health Care Reform at Brookings, stressed that it needs to be determined who will be responsible for the various aspects of Sentinel, who will be able to use the Sentinel infrastructure, under what conditions, and most importantly, how will the program be sustained financially.
There are several initiatives both in the public and private sector that are able to provide information and input to FDA such AHRQ’s Effective Health Care Program, Brookings forums on postmarket evidence, eHIs drug safety collaboration, HMO research network, and pilot efforts conducted by numerous health plans and integrated delivery systems. In addition, work conducted under FDA contracts can provide input.
All agreed that it is important to communicate with consumers and providers on their concerns, find out what they need to know, and how to best educate the public concerning the risks and the benefits of medical products.
Legal and privacy issues are high on the agenda and discussions need to take place on what necessary protections are needed to ensure data privacy and whose responsibility is it to ensure that privacy is protected.
The next step is to study the outcome and discussions from the workshop, and to create draft documents for establishing partnership, governance policies and procedures. These documents will be worked on over the next six months. The goal is to have access to data from 25 million patients by July 1, 2010 and to 100 million by July 1, 2012.
