Optimizing Product Value Postmarketing

Real-world evidence is needed to keep a pharmaceutical product on the market

Optimizing Product Value Postmarketing

Experimental clinical trial data are needed to bring a product to market, while observational data are important to keep a product on the market and meet the requirements of stakeholders, including prescribers, patients, payers and regulators.  These observational data ─ or real-world evidence ─ are also what’s needed to optimize your product’s value throughout its lifecycle. This can even include activities conducted pre-marketing as well to understand the natural history of a disease being treated by the experimental drug or biologic. Considering the investment sponsors make in research and development, it makes sense to carefully consider how real-world evidence is gathered and analyzed and how it can help keep your product front and center in the minds of prescribers and patients.

In addition, payers’ interest in outcomes-based pricing contracts is increasing significantly. Sponsors will need to implement the most effective research methods to gather outcomes-based evidence quickly and efficiently.

While clinical trial data are gathered from a relatively small patient population in a tightly controlled seting,  real-world evidence is gathered from much larger patient populations in a variety of clinical settings.  Data sources include medical and pharmaeutical claims, electronic health records, and ad hoc studies.  In recent years, sources often include social media and patient forums.

Through a 2014 industry survey1, we learned that the majority of sponsors use data from registries and observational cohort studies when gathering real-world evidence. However, valuable insights and evidence can be gathered from a variety of other research methods, including  retrospective studies and chart reviews, time and motion studies, and patient and healthcare provider surveys.

Recognizing what types of data will help secure a product’s place in the market and prioritizing the research needed surrounding that data can sometimes lead sponsors in many directions, taking up valuable time and resources. The diagram below shows just some of the real-world evidence needs stakeholders may be requesting throughout a product’s lifecycle.

The table below shows what types of studies & research can help gather real-world evidence:

*Evidence diversity and quantity can be limited based on availability in literature.

While these lists are not intended to be comprehensive, they may help identify gaps in information needed to tell your product’s full story.  If you are interested in discussing the right observational study design to best support your product’s evidence needs, please contact me or stop by booth #2215 at DIA’s Annual Meeting.  I look forward to talking to you!