The current method of reporting adverse events (AEs) is based on manufacturer, clinical trial sponsor and investigator, physician, and even patient reports to the FDA. We all know that the agency is interested in “serious, unexpected, suspected adverse reactions”, as defined by their standards.
However, based on what is published from many sources, the current methods are not 100% satisfactory. The FDA still gets dinged by the OIG and consumers still complain. Lawsuits happen.
In May of 2008, the FDA launched the Sentinel Initiative. On their website, the agency describes the initiative as follows:
“The Sentinel Initiative aims to develop and implement a proactive system that will complement existing systems that the Agency has in place to track reports of adverse events linked to the use of its regulated products.”
A few years ago, I was able to look into the methods that the FDA was proposing to include in the initiative and the new data sources included medical and claims records and prescribing data. I agree that these data sources will be valuable in the overall long-term post-marketing evaluation of products.
However, I was struck by something else. We know based on our work in Internet conversation analysis and years of healthcare marketing that patients take quite awhile to go from healthcare complaint or issue to actually going to the doctor. I have seen patients take up to a year to go to the doctor for a problem so we can assume that it would be weeks at best before a patient sees their doctor about a perceived problem. And we know that it takes at least 2 months for data from a medical visit to get from the physician to claims data to someone to analyze the claims data. So the time from complaint to usable data will be at least 3 months.
A lot can happen in 3 months. No doubt that the Sentinel Initiative is a needed project. However, I see it akin to trying to identify patient zero in an epidemic – an extremely important task for containment and treatment but sometimes one that just lets us watch a terrible problem spread around the world.
At the same time, over the last 10 years the Internet has become a central part of how patients manage their diseases and conditions. Patients actively discuss how they feel their medication is performing based on their own experiences. And in many cases, patients are aware of clinical standards and are sophisticated in their evaluation of product performance because of their extensive personal research and interaction with other patients.
So I thought, what if we could offer an additional method for measuring safety and also efficacy based on this real-world experience? Yes, there are Phase IV/V studies but today, they are accomplished in the current clinical trial format that is still not really “real world”. I understand why trials are done the way they are; I have been a researcher. However, many researchers also agree that the study format makes it hard to really see what will happen when a drug is released into the “wild” without the supervision of inclusion and exclusion criteria and strictly monitored adherence regimens.
Wool Labs is working to develop Phase IV/V programs to look at safety and efficacy of products through the lens of how patients report performance and experience. We already work with clients as well as publish our own research on how patients discuss their diseases and conditions, medication, and safety and efficacy measures.
So the point to this blog is to explore this concept further. We are working today to define our first such study with a major university (more as time unfolds). But I want to discuss how what we already see today and the protocols needed in the future. I am interested in advancing the debate of using different and more “real world” methods for evaluating the performance of products that still can be scientifically rigorous but offer earlier signals and insights into the future.
No comments:
Post a Comment