Real world data offers an alternative approach to observational research, particularly to inform decisions on patient needs and preferences.

The key to encouraging patient participation in clinical studies of any kind is to use patient feedback to inform the earliest stages of development to ensure that the treatment will address patient needs and reflect their preferences. However, the expenses associated with enrolling patients in randomised clinical trials, compensating providers, and following patients over several years can amount to millions of dollars each year.

The availability of real-world data (RWD), driven by the wide adoption of Electronic Health Records (EHRs), presents an alternative approach to observational research and is suitable for prospective, retrospective, and hybrid studies. Real-world evidence (RWE) can be used in many ways – from continuous monitoring and studies of drug utilisation to routine safety monitoring and filling evidence gaps.

Truly understanding patient needs and priorities means engaging directly with patients, families, and patient advocates to develop high-value, trusting relationships. A variety of methodologies – ranging from interviews, surveys, social listening, and co-design workshops, to study visit simulations – can be used to gain a holistic view of patients’ ecosystem and how it influences their decisions and behaviours.

With big data solutions advancing to the forefront of the healthcare ecosystem, companies must build—or have access to—a technology platform capable of generating a continuum of insights from EHRs and other RWD sources. As the integrity, quality, and timelines of the data collected improves, more and more clinical trials will employ electronic media, such as smartphones and tablets, to collect patient-reported outcomes.

ICON's experts collaborate with your subject matter experts to deliver a unique, intelligent RWE strategy for increased clinical research efficiency, and targeted plans that can enhance your value story and provide compelling evidence for stakeholder engagement. We call this approach Real World Intelligence™. To learn more please contact us.


This blog is an edited version of “Encouraging patient participation in real-world studies” which appeared in the June 2020 edition of Pharmaceutical Market Europe. To view the full article, please visit http://digitaleditions.pmlive.com.