Real-World Evidence: The Work Isn’t Over After a Clinical Trial

Real-World Evidence: The Work Isn’t Over After a Clinical Trial

Life science industry professionals turn to the Worldwide Evidence team of experts who objectively and credibly establish and communicate evidence of value in actual-practice real-world settings, using operational approaches that increasingly embrace advanced technology. We combine strategy and planning, health economics and outcomes research, observational research and patient registries, post-approval safety studies, and patient outcome communities to document the clinical, economic, and humanistic value of innovative drugs and devices throughout the entire product life cycle. In this video, Dr. Michael Murphy, Chief Medical and Scientific Officer at Worldwide Clinical Trials, talks about how combining interventional expertise with observational expertise can produce groundbreaking results for real-world evidence.

Well, the general question has been: Is there a rapprochement between observational and interventional studies, and it’s possible the answer is yes. One of my colleagues at Harvard, who is an epidemiologist, said: You know Mike, I listen to you all the time, you do interventional studies, and I’d like to say it’s like you’re speaking American English and I’m speaking British English. We mostly understand each other, although the terminology is somewhat different. So what we’re attempting to do as an organization, exemplified by the recent acquisition of the evidence company, is blend the two together.

So, let’s talk about one area where complementarity is required. We have often said, and we’ve said for over 20 years now, that developing a product strictly based upon its novelty is not enough in today’s competitive market. It might be a requirement to have a discussion, so to speak, but it’s not enough to assure success. And by success I mean formula replacement and patient access. After all, we developed these agents, not to exist in isolation, but hopefully to promote patient access. Well, the number of individuals responsible for making that decision are quite diverse. We have the doctor. We have doctor investigators, which are actually different than community-based physicians. We have regulatory affairs specialists. We have broadly-defined peer groups that dictate whether or not it’s on the formulary and whether or not you can actually access that for any given disease. They all have remarkably different requirements for data. Usually, that requires that you have remarkably different ways of generating the data during a prototypical registration program. So we have found, by combining the best of interventional research with the best of observational research, we can largely accommodate these very apparently-conflicting interests that occur during a typical development program.

I need a highly leveraged patient sample. Patients that are not representative of those maybe that you customarily might think of in terms of community-based disorder. And are certainly do not need physicians that are not specialists in research. I need you to understand the dynamics of research at a GCP environment. But those are not representative of the patients that will eventually get the product. A payer, in contrast, wants to know about, I call it the patients in the deep end of the swimming pool, everyone with the comorbidities and the complexities that really largely are responsible for driving up utilization and driving up cost. Notice how different those two groups are. Accommodating that in the middle of a program is very artful, but could be done by merging together the best of observational with the best of interventional research. And actually there’s a significant overlap between the two. So our evidence-based group are masters at doing that. They understand the dynamics, the operational demands of different types of observational studies. Our interventional team is usually quite expert on disease entities, how a patient presents, what the patient uses, disease trajectory. Put those two things together and one would have a very comprehensive and integrative solution, again, satisfying the needs of multiple different stakeholders along the way.

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