The increasing availability of big data is creating a shift in the clinical research landscape allowing for clinical research professionals to make intelligent, strategic decisions based on real-world evidence (RWE), which is derived from the aggregation and analysis of real-world data (RWD).

As the integrity, quality, and timelines of data collected improves, more and more clinical trials will continue to employ electronic media, such as smartphones and tablets, to collect patient-reported outcomes. 

Patient enrolment is a common hurdle in clinical trials, and enrolment processes can consume up to 40% of the industry’s clinical trial budget and sponsors often struggle to identify the best sites and enrol the target number of patients. Leveraging RWD can improve enrolment in 3 ways:

  1. Through a protocol feasibility assessment, researchers can use RWD to estimate the size of the available patient population, given the inclusion/exclusion criteria.
  2. The criteria can be applied against de-identified patient data from providers’ EHR systems to determine eligible patients by provider, allowing sponsors to focus on sites that serve a population that aligns with the protocol criteria.
  3. The software can be programmed to alert physicians to suitable patients within their practices, thus giving providers the opportunity to consent and enrol prospective participants into the trial.

For sponsors to derive the full benefit of RWD, it is essential to use technology-enabled research applications and a fit-for-purpose RWE platform. The platform can serve as a foundation that can maximize return on investment by supporting:

  • Assessment of intended product use
  • Ad hoc analytics
  • Long-term safety studies
  • Virtual registries
  • Patient profiles
  • Treatment patterns
  • Protocol feasibility
  • Patient recruitment
  • Comparative effectiveness

By adopting these strategies, sponsors can drive research efficacy, enhance a product’s value, provide evidence for targeted stakeholder engagement, and achieve key commercial objectives for their products. While some challenges exist – for instance, data sources remain fragmented and systems are diverse – sponsors should view RWE as an efficient and cost-effective tool to support the success of clinical trials. A new era is now emerging in which clinical practice and clinical research inform one another through RWE.

For more information on this topic, please contact us.


This blog is an edited version of “RWE Continues to shape the future clinical research landscapes” which appeared in PharmaVoice in June 2018. To view the full article, please visit

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