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Q: The
Critical Path Initiative (CPI), FDA's nationwide strategy to drive
innovation and modernize regulatory science, is now in its fourth year
of operation. Do you view it as a
success?
RB: Yes, I consider the Critical Path Initiative a big success. CPI was launched in 2004 to modernize the tools and processes we need to turn discoveries in science and technology into new medical cures. Although CPI initially focused on medical products, like drugs, medical devices, and biologics, the CPI model was soon applied to all FDA-regulated products. In 2008 alone, congressional funding for CPI supported a total of 46 different Agency-wide research projects. Research ranges from efforts to develop new technologies for personalizing cancer treatment and therapies for Alzheimer's to improving FDA's ability to respond to emergency food contaminations. In most cases, the projects represent collaborations not only among FDA centers, but with outside stakeholders in the U.S. and abroad.
Q: In what way do you think CPI has enhanced FDA's ability to protect and advance public health?
RB: Without a doubt, the powerful partnerships and collaborations we've formed to date have been CPI's biggest contribution. They've made it possible for us to leverage resources for research that is laying the groundwork for transforming medical treatment. For example, through a collaboration, we recently made information available to physicians that will improve the prescribing of warfarin. We are collaborating to develop an artificial pancreas to improve the treatment of diabetes.
We foster collaborations not only within FDA but with a wide variety of organizations, from federal agencies, academia, and industry, to nonprofit organizations and patient groups. Collaboration is the cornerstone of CPI; it's what makes our work possible.
Q: Why is collaboration so necessary for CPI?
RB: Emerging areas of science, evolving technologies, and globalization now offer us unimaginable opportunities for new medical treatments and ways of ensuring food and drug safety. But these trends also require us to modernize the tools and processes by which we take scientific breakthroughs from lab bench to bedside—and protect the food and drug supply. And modernizing the development, evaluation, manufacture, and use of FDA-regulated products cannot be done by one entity alone. It's an expensive, long-term, and complex endeavor that demands the insight, collaboration, and resources—human and fiscal—of organizations that might normally compete in the marketplace.
Q: Why is FDA best suited to drive this effort?
RB: Because we are uniquely positioned to act as a catalyst; we alone can help identify the challenges to development, evaluation, manufacturing, and use of FDA-regulated products. FDA scientists can see the complete spectrum of successes and best practices, along with the failures, slowdowns, hurdles, and missed opportunities. When challenges arise in the process, or problems recur, FDA must bring them to the scientific community's attention, then bring the relevant players to the table to explore the problems and find ways to solve them. CPI has galvanized the support and involvement of relevant stakeholders like NIH, pharmaceutical manufacturers, academic institutions, and patient groups. We've sought out their ideas, perspectives, and commitment. You could say that collaborations are really hardwired into the Critical Path Initiative's DNA!
Q: Can you give us some examples of Critical Path collaborations?
RB: Well, we're involved in a number of collaborations as part of our bioinformatics effort, bioinformatics being the science and technology of managing and processing biological information. For instance, we're working closely with national and international standards-setting organizations such as Health Level Seven. And many of the CPI research projects launched in 2006 and 2007 involve collaborations. But I think the most exciting examples, which are quite high-priority at FDA, are the Clinical Trials Transformation Initiative (CTTI) and the Sentinel Initiative.
Q: Could you tell us something about the Clinical Trials Transformation Initiative, or CTTI as it's called?
RB: FDA and Duke University co-founded the public private partnership CTTI in November 2007 with the goal of modernizing the way clinical trials are conducted. Its multi-stakeholder Executive Committee (EC) includes representatives from FDA, Duke, academia, patient advocacy groups, and industry. And the National Institutes of Health (NIH) and the European Medicines Agency (EMEA) have provided liaison representatives to the EC. The collaboration has more than 50 members representing a wide range of stakeholders in the clinical trial enterprise.
Q: What's the goal of CTTI?
RB: CTTI brings together all interested stakeholders to identify practices that, through broad adoption, will increase the quality and efficiency of clinical trials. The outcome of CITTI will be improved clinical trial safety, a boost in the quality of information gathered during clinical trials, and a more efficient research process.
Q: Who leads CTTI?
RB: Robert Califf, M.D., Vice Chancellor for clinical research at Duke University, and I are co-chairing the Executive Committee.
Q: Have any CTTI projects been launched?
RB: Yes, we've made a lot of headway. The Executive Committee approved four project proposals this past year. They are projects to evaluate and identify best practices in clinical trial monitoring; to improve the communication of serious adverse events in clinical trials; to identify principles for reporting clinical trial data publicly; and to identify and document best practices for managing data collected in cancer trials.
We'll continue work on these projects and to encourage multi-stakeholder contribution and participation. We'll also identify additional projects based on submitted concepts from the public.
Q: Haven't you also launched an initiative to design and build a nationwide electronic system for monitoring drug safety?
RB: Yes, we launched the Sentinel Initiative in May 2008. This is an exciting, long-term collaboration, which will entail FDA working with large medical data holders like the Centers for Medicare & Medicaid Services (CMS) to develop tools and methods that will enable FDA to send out questions to these organizations to evaluate their data for possible safety problems associated with the use of medical products. FDA, in consultation with other experts, will develop the queries and participating partners will send the query results back to FDA for further evaluation.
This initiative is in the very early stage. Right now, we're trying to identify the optimal governance model for the system. Some smaller collaborations have also been launched in the private and public sectors that will directly influence the Sentinel Initiative's development.
Q: Can you give us some examples of projects that will contribute to the Sentinel Initiative?
RB: FDA and CMS, with the assistance of the Assistant Secretary for Planning and Evaluation (ASPE), have launched a pilot that will use Medicare data to better understand the safety of FDA-regulated products after they go on the market. The project's goal is to help us explore medical product performance, safety, and other clinical results among elderly patients.
Another example of a project that is contributing to Sentinel is the Observational Medical Outcomes Partnership (OMOP). FDA, PhRMA (Pharmaceutical Researchers and Manufacturers of America), and the Foundation of the National Institutes of Health founded the collaboration OMOP, which is governed by a multi-stakeholder Executive Board. Then there's eHI.
Q: What is OMOP's goal?
RB: OMOP will be assessing the value, feasibility, and utility of observational data to identify and evaluate medical results—primarily risks, but also benefits—associated with prescription drugs. A range of analytical methods will be used. Researchers will also test approaches for creating an infrastructure for accessing and managing the data being evaluated.
Q: What's the goal of eHI?
RB: The eHealth Initiative (eHI) pilot study (Connecting Communities for Drug Safety Collaborationwith HealthCare System and Regenstrief Institute/Indiana Network for Patient Care) is another activity that will inform Sentinel. eHI is exploring opportunities for using clinical information captured in the electronic databases of two large health information exchanges to identify and assess safety signals associated with drugs on the market. FDA is acting as an adviser on the pilot study.
Q: How do you see the Critical Path Initiative evolving in 2009 and 2010?
RB: CPI has become the foundation for much of the innovative research work going on at FDA as well as most of the scientific and technical collaborations taking place here today. The Initiative is also playing an increasing role in risk management.
Q: What is risk management?
RB: I'll give you an example. Concerns have arisen about drug-eluting stents, which are used to treat blocked coronary arteries and the possibility of drug-eluting stent thrombosis, which sometimes occurs later after the stents are implanted. Although the total number of reported cases has been relatively small, these events raise an important safety issue because thrombosis is associated with acute myocardial infarction. Stents are widely used, and use will continue to grow as our country's population ages.
Q: What is FDA doing about managing the risks associated with drug-eluting stents?
RB: FDA is leading a collaborative effort that, if successful, will result in a clinical trial to determine the best uses of anti-platelet drugs in patients receiving drug-eluting coronary stents. The collaboration involves multiple manufacturers, and I doubt that such a collaboration would be possible without FDA's encouragement and sustained support. This is exactly the kind of effort that demonstrates the value of the Critical Path Initiative and its role in innovations and improved patient safety.