Current clinical pathways are largely based on generalized measures such as evidence-based guidelines and consensus best practices. Yet electronic medical records (EMRs) contain a tremendous amount of data that, when operationalized, provide valuable information about the quality of care delivered as well as areas for improvement.
A variety of technologies have been developed that allow practices and health care systems to extract meaningful outcomes from their own patient data and apply that information to subsequent care decisions. In his session, Dr Norden highlighted the platforms and tools now available for applying a more data-driven approach to informing the development and analysis of clinical pathways in order to continually improve patient care.
There has been talk around the potential of real-world evidence to impact or enhance clinical trials as a way to personalize care. In what ways can real-world evidence complement clinical trials?
I think clinical trials serve a critical purpose in proving that a given intervention is effective in a certain population. The reason that real-world evidence has a potentially important role is that a lot of patients in the country do not, cannot, and are not offered opportunities to participate in trials. That is a problem in and of itself that we need to work on—the reality is only 3% to 5% of patients today participate in clinical trials. We end up with a very narrow segment of the population that is offered that opportunity.
It is also the case that clinical trials are slow and often very expensive—tens and millions of dollars or more in some cases. Also, for rare disease, it often becomes impossible/unfeasible to conduct a clinical trial in a given circumstance.
For all of these reasons, there is potential to make the evidence base more robust by incorporating real-world data. I also look at it from the perspective that we have spent the last decade getting providers onto EMRs to the point that, today, they are ubiquitous. In turn, we have enormous amounts of electronic data that often and granularly represent patient journeys in a way that other data sources do not. Because the EMR is used for all patients, we get a really clinically represented group of patient data captured in the EMR.
There is a lot of complementarity between real-world data and clinical trials. We should use both sources to supplement and create a full representative data set.
How can real-world evidence be used to help to build, improve, or expand on a hospital’s clinical pathways program? What is Cota specifically doing to facilitate this?
To date, clinical pathways are generally informed by expert panels that review published evidence. Clinical pathways are created on the basis of that kind of critical information. That is fully appropriate and should not change. But my view is that there is an opportunity to supplement the perspective given by clinical trial data, guideline data, and expert opinion with what actually happens in the real world.
That is where a company like Cota can contribute quite meaningfully to the development of clinical pathways. Today, some of the clinical pathways companies do use “real-world data,” which generally means they review retrospectively how well a particular organization or set of physicians adhered to clinical pathways. When they find low adherence rates, they then use that information to inform their thinking about whether the pathway is on target or not.
That being said, there are all sorts of real-world data that one could use. One could look at real-world toxicity rates, which are often different from toxicity rates in clinical trials. One could look at real-world outcomes. One could look at real-world costs, which vary across geographic regions and from patient to patient based on many factors.
My view is that clinical pathways are a really effective tool today—using published data, guidelines, and expert opinions. I think we can make them somewhat more robust if we incorporated all sorts of real-world data that Cota is making available. We can work together with pathway vendors and organizations that are developing pathways such that we can infuse those with real-world data and make them even more robust.
What is the single greatest benefit of real-world evidence applications in clinical oncology care?
There are a whole variety of potential benefits of using real-world data in a way that happens today at small scale. From my own perspective, the potential power here is that we could use real-world data to effectively manage unwarranted variation in treatment choice and in all of the other decisions that physicians make that go along with treatment choice. If doctors had, at their fingertips, granular data about how patients are treated, and if one could integrate that with detailed information about outcomes and costs, I feel really confident that physicians would be much more inclined to make fewer variable choices that optimize value at every turn.
To me, that is the opportunity of real-world evidence. When doctors make decisions today, they do so in a vacuum, and they do not have access to detailed information about how they themselves have treated patients in the past or what outcomes and costs have been observed in the wake of the decisions they have made. Real-world data and real-world data analysis provide an opportunity to put that information squarely in their view. It can help optimize every decision they make, leading to data-driven decisions rather than decisions in a vacuum.
In the competitive world of clinical oncology, how do you go about creating a culture of data sharing?
Data sharing is really important to everything I have talked about. The more effectively the health care community can share data, the better every decision every stakeholder in the health care community will be able to make. I agree that data sharing is important, and there are a lot of obstacles to it today. One of the biggest obstacles is technical—just a pure lack of interoperability between systems. There are regulatory reasons why data is not shared as robustly as it should be (ie, HIPAA). There is a lack of standards for data element type. There are all sorts of barriers that intervene.
My own view of this is that increasingly patients are starting to own their data in a way that they did not in the past. My hope is that making patients central to this process, that we will start to see a call by patient communities for data to be shared openly between all of the folks who need to use their data (ie, payers, providers, life sciences companies). That is the direction that I see us going. I see an effort from a company like Cota to put data in the hands of patients is an important first step. We are really in on making the real-world data that represents a patient’s journey available to the patient. Rather than saying it is owned by the provider, we should make it owned by the patient, and then the latter can decide when, where, and how it is shared. Doing so will reduce corporate bureaucratic and regulatory barriers to data sharing that exist today.
We certainly hear a lot about what Apple has done to make patient data available in their iPhones. In truth, what they have access to today is somewhat limited. Imagine scaling that up to a point where patients are the owners and arbiters of their medical records. It only makes sense that that should be the case. All of the data relates to the patients themselves, and certainly in the scenarios where I am a patient, I want to be in charge of my data and what happened. It just seems only natural and reasonable.
