//Real World Evidence – eyes wide shut

Real World Evidence – eyes wide shut

Thanks to a new focus on patient centricity, pharma companies and patients are engaging more closely (Read: A winning affair).

In the past, drug related data resulted primarily from clinical studies. Nowadays, real-world evidence (RWE) completes the picture. Advantages include the availability of timely data at reasonable cost, large sample sizes that enable analysis of subpopulations and less common effects, and observation of real-world practice and behaviors (1). All of which could result in identifying new patient groups and improving communication on a drug’s benefits.

Along with all the benefits, more RWE has its challenges for pharma. The elephant in the room, standing in the way of communicating directly with patients, are adverse events (AEs). Because taking a closer look could reveal additional AEs.

A potentially longer side effect profile worries pharma. With a longer or more severe side effect profile doctors don’t like to prescribe a drug. For example a 2005 FDA advisory concerning the increased risk of mortality associated with the use of atypical antipsychotics in elderly patients with dementia was associated with a decrease in the use of the medications. Monthly drug uses dropped by more than 50% from April, the time the advisory was released to December of 2008 (2).

According to Mikolajczak, C. traditional data collection with forms or patient diaries will be replaced by digital solutions that connect directly to patients and cover identification, qualification and reporting of AEs tailored to company requirements (3). The following prognosis seconds this with the global Real-World Evidence (RWE) solutions market expected to grow at a CAGR of 15.0% from 2019 to 2024 to reach $1.64 billion by 2024, pharma has to keep up (4).

For some, this increased closeness to patients could be worrying. But according to a recent analysis on reporting of adverse events on social media, there were only 5-10% potential AE’s reported. And almost none of these matched the requirements for filing an AE with the health authorities fully (3).

Therefore, the risk of starting a digital dialog around RWE directly with patients is manageable. And the benefits outway the risks. 

Preview: RWE – solutions to enable data collection

Stay connected, stay healthy!


P.S.: Ariana can provide you with real time patient data – get in touch to learn how she does it


  1. ISPOR: Real-World Evidence (2020). https://www.ispor.org/strategic-initiatives/real-world-evidence
  2. Dorsey, E. R., Rabbani, A., Gallagher, S. A., Conti, R. M., & Alexander, G. C. (2010). Impact of FDA black box advisory on antipsychotic medication use. Archives of internal medicine, 170(1), 96–103. https://doi.org/10.1001/archinternmed.2009.456
  3. Mikolajczak, C. in Pharmaphorum: Social media listening: uncovering patients’ needs. https://www.iqvia.com/-/media/iqvia/pdfs/cese/germany/news/iqvia-social-media-listening-artikel-2017.pdf?la=de-de&hash=C5EE8FCE73016BB6C1C6E78DE83C7561
  4. Meticulous Research (2019). Real-World Evidence (RWE) Solutions Market – Global Opportunity Analysis and Industry Forecast (2019 – 2024). https://www.meticulousresearch.com/product/Real-World-Evidence-Solutions-Market-4954/?utm_source=wiredrelease.com-pharmiweb&utm_medium=Savi_13Feb2020