In our current situation, where many healthcare sites are overburdened, alternative research methodologies such as DATABASE STUDIES, allow Real World Evidence generation to keep going.
During these unprecedented times, when the global healthcare system is dealing with the COVID-19 pandemic and resources are being redirected to support frontline care, access to researchers is more restrictive. Meanwhile, social distancing and physical distancing restrictions put in place for the safety of our communities mean that patients are only visiting their physicians when necessary, resulting in disruptions or delays to ongoing, non-priority studies.
However, the need for Real World Evidence (RWE) continues to be a critical component of decision making, despite the current challenges in conducting site-based research.
Healthcare stakeholders and decision makers are increasingly relying on evidence derived from Real World Data (RWD) to guide and help influence decisions ranging from regulatory approval, to reimbursement, to treatment decisions in the clinic.
Prior to the current situation, there had already been a gradual paradigm shift in favour of reviewing drug effectiveness and safety earlier in the product lifecycle to facilitate access to medications in an expedited fashion, particularly for rare disease and oncology.
The challenge of site burden is not a new issue. With an average of 54 new active substance launches each year globally, and the implementation of cost containment measures, the need to differentiate from competitors is increasingly important. Site-based RWE studies can be time consuming, costly, and involve a high degree of administrative burden. This latter factor has already been shown to be critical in researchers’ willingness to participate in these studies.