How well has RWE integrated into Medical Affairs—and should more be done?
Payers and other stakeholders increasingly expect to see real world evidence (RWE) to support their decision making. Since being added to the medical affairs remit, RWE has taken hold and is actively proving its worth within pharma. Used in R&D, regulatory decision-making, pricing, reimbursement and clinical decision-making—the demands on RWE are growing by the day. But as this complex area becomes ever more sophisticated, how well are medical affairs departments coping with their newest addition? How is RWE evolving? And is your team structured in the best way to get the most from the opportunities resulting from RWE?
We spoke to 7 senior medical affairs and RWE experts at the forefront of this complex discipline. Find out what they said, in their own words, on all the key issues.
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What to expect from this report
The RWE team may have begun as an 'add-on' to medical affairs in response to the big data revolution but its role and importance has grown significantly. Reams of data are now transformed into powerful insight that drives decision-making. And as RWE is now embedded into medical affairs activities, its influence and impact is increasing.
Real World Evidence: The Role of Medical Affairs reveals how this crucial specialist area is evolving and how its natural 'home' within the medical affairs team also needs to move forward.
What did we do?
Example insight included in Real World Evidence: The Role of Medical Affairs
"Experts emphasise the importance of having a cross-functional team that includes medical affairs to agree the RWE strategy and implementation. Medical affairs can help to design studies that will answer the most appropriate questions. For example, medical affairs may be able to suggest outcomes such as different aspects of utilisation or inclusion of a broader patient population that would not otherwise have been considered. Key insights from medical science liaisons can also be incorporated into study design so that the outcomes can be shared with physicians who had specific questions."
Example quote included in Real World Evidence: The Role of Medical Affairs
"The issue that we have here is that a traditional medical affairs workforce hasn't really worked on or had that kind of an intellectual or technical expertise in real-world evidence. Real-world evidence has evolved within different scientific disciplines: mostly drug epidemiology, observational research, health economics and outcomes research, and patient-centred research. It's a conglomeration of different interrelated scientific disciplines which, from a legacy standpoint, weren't traditionally present in medical affairs. The assumption was that you invest in real-world evidence, you create a separate function, you have it report to medical affairs and the job's done. That's not how it works; real-world evidence has to be fully integrated with the medical strategy."
The expert panel for Real World Evidence: The Role of Medical Affairs
Why buy now?
Generating robust, meaningful and scientifically sound RWE is now imperative for every pharma company. Whether to demonstrate to payers that their expectations of new drugs are met, to prove the case for biosimilars, or to increase the market share of existing drugs by highlighting competitive advantage: the benefits of getting RWE right are many. This report shows how RWE capabilities within medical affairs can live up to its promise, but only when both skill sets are working in tandem and are fully integrated.
Find out how to make that happen in your organisation.
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