How important is Real World Evidence (RWE) in building your competitive late phase portfolio of evidence?

Consider the following scenario. Before entering your career, you probably took a course or two, studied for a few years and obtained a degree or even a post-graduate degree. That qualification provided you with a sound theoretical background. However, the real learning only took place when you finally started working in the industry. There is no doubt that real world experience resulted in much more depth and insight into your area of expertise, making you more valuable to your company today. For this reason, most employers secretly tend to prefer experience over qualification. This is true in most industries, hence the well-known term ‘over-qualified, under-experienced’. Think of it this way, when you are faced with a dying cactus, who would you rather call for advice, your friend with a theoretical background in horticulture, or your uncle who has been operating a successful cactus nursery for over 30 years? This doesn’t mean that an academic qualification is not necessary, on the contrary, it provides a much-needed foundation, and not to mention the fact that it eliminates the need for re-occurring trial and error. It just states that, when it comes to decision-making, experience trumps theory.

It is no wonder why “real world” evidence (RWE) has become an increasingly popular topic in the global health market today. As the cost of R&D increases, there is a shift towards looking for answers and quantifying value in new ways.

Even science has seen a shift. If science is the search for truth, where do we start searching, and what is the real truth? Is clinical research, which proves efficacy under prescribed conditions, enough evidence to support commercialisation of products? Or can we compare it to the “theoretical background” concept mentioned earlier? RWE provides outcomes and safety data outside the limited framework of clinical research, providing a deeper insight and depth into a product’s real-world therapeutic effectiveness and side effects. Much in the same way as “work experience” makes you a more valuable employee.

Regulators, payers and providers are all asking new questions regarding value and validity. If the concept of “value” is so subjective, how do you quantify value in a complex and multi-dimensional world sufficiently enough to be convincing to all parties involved? This article in the African Journal of Outcomes Research, attempts to answer these pressing questions and demonstrates how RWE can benefit you in building your competitive product portfolio.

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