When Clinical Trial Sites Become Outliers: Global Challenges in Drug Development
Clinical trials are the foundation of pharmaceutical innovation, determining whether new therapies make it from lab to patient. Over the past two decades, trials have shifted from a largely Western-centric system to a global enterprise, with sites spread across Eastern Europe, Asia, Latin America, and Africa. This expansion brings cost savings and faster recruitment, but also introduces new vulnerabilities.
The Bulgarian Outlier in Hypertension Research
The recent dispute between Novo Nordisk and KBP Biosciences illustrates this tension. Novo’s $1.3 billion acquisition of the hypertension drug ocedurenone is now mired in litigation after a Phase III trial was stopped for futility. Central to the case is a trial site in Bulgaria, whose patients showed unusually positive results compared with other sites. Novo alleges that when these outlier results were excluded, the drug’s efficacy essentially vanished. Audits later highlighted compliance concerns at the Bulgarian hospital.
Financial Incentives for Hospitals
Pharmaceutical companies routinely pay hospitals large sums to host trials. In well-funded Western health systems, these contracts are just one stream of income. But in less wealthy regions, the infusion of sponsor funds can be transformative. This financial dependence, however, may distort behavior. Physicians might consciously or unconsciously report results in ways favorable to sponsors, particularly when continued funding hinges on “successful” participation.
Simpler Endpoints, Higher Risks
Not all trials carry the same vulnerability. Studies with numerical endpoints such as systolic blood pressure in hypertension may be easier to bias than oncology trials requiring radiology review or biomarker analysis. In simpler trials, even small shifts in recorded values can change the apparent effectiveness of a drug.
It would be unfair and inaccurate to suggest that all or even most trial sites in emerging markets engage in misconduct. The Bulgaria case highlights how one site’s data can alter the fate of an entire drug program and why choosing trial sites carefully is critical to ensure reliability and credibility.