LinkedIn·Wednesday, 29 July 2026·28d ago
Is the geography of clinical trials creating a new hidden risk for drug development? For decades, Europe has been a reliable region for…
Bernard Vrijens
Chief Executive Officer & Scientific Lead | Honorary Member of the International Society for Medication Adherence | Exposure-informed clinical trials.
Is the geography of clinical trials creating a new hidden risk for drug development?
For decades, Europe has been a reliable region for clinical research. Strong healthcare systems, easy access to care, experienced investigators and highly engaged patients have contributed to relatively high protocol adherence and strong site performance.
--> Today, however, the geography of clinical trials is shifting.
As pharmaceutical companies increasingly prioritize growth markets and adapt to changing economics, we are seeing fewer sites allocated to Europe and greater reliance on the US and emerging APAC regions. While this evolution brings many opportunities, it also introduces an often-overlooked challenge: greater variability in how study participants follow protocol requirements and take study medication.
Patient behavior, healthcare access, cultural factors and care settings differ significantly across regions. As a result, the same protocol may generate very different levels of adherence and persistence across geographies.
The consequence?
👉 More uncertainty around actual treatment exposure.
👉 Increased data variability.
👉 Reduced statistical power.
👉 Higher risk of inconclusive or failed studies.
In an era where sponsors carefully monitor every aspect of study execution, it is surprising that the actual implementation of treatment by participants is still frequently assumed rather than measured.
As clinical trials become more global, digital adherence monitoring is no longer a nice-to-have. It is becoming a critical component of risk management.
If we want to understand whether a drug worked, we must first understand whether it was taken as intended.
Measuring treatment exposure may prove just as important as measuring clinical outcomes.
#ClinicalTrials #DrugDevelopment #DigitalHealth #PatientAdherence #ClinicalResearch #ICHGCP #ICHER3 #Pharma #Biotech #DecentralizedTrials #ClinicalOperations #MEMS #AARDEX
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