While interventional, randomized double blind placebo-controlled studies are the gold standard used to assess efficacy of interventions [1], answering other scientific questions does not necessarily require an active intervention. My point is not to dis experimental studies in any way, as experimental studies are considered to be more reliable than observational studies because the process… Continue reading To RCT or not to RCT?
Category: Data
Transportability in Real-World Evidence (RWE) Research: Regulatory Considerations
What is Transportability in RWE?Transportability in Real-World Evidence (RWE) research refers to the ability to extend findings from one study population to a different, but related, population. This concept is critical when evaluating whether treatment effects observed in one geographical region, healthcare system, or patient cohort could be generalized to another population with different demographic,… Continue reading Transportability in Real-World Evidence (RWE) Research: Regulatory Considerations
Exploring RWD Beyond Healthcare: Driving Innovation Across Industries
In recent years, the use of real-world data (RWD) has become an important aspect of decision-making in healthcare and clinical research, transforming how clinical and medical evidence is generated. However, the potential of RWD extends far beyond the field of medicine. Across diverse sectors—from transportation to retail, agriculture to entertainment—organizations collect data generated from everyday… Continue reading Exploring RWD Beyond Healthcare: Driving Innovation Across Industries
HealthData@EU: Cross-Border Healthcare Data Sharing in Europe
With the evolving data-driven innovation, the ability to securely share health information across borders has become important for advancing medical research, improving patient care, and supporting public health initiatives. The European Union has taken a significant step forward with HealthData@EU, an innovative initiative aimed at creating a unified framework for cross-border healthcare data sharing. … Continue reading HealthData@EU: Cross-Border Healthcare Data Sharing in Europe
AI-Driven Protocol Digitalization: Reshaping Clinical Research
The integration of artificial intelligence (AI) into clinical trial protocol digitalization is transforming key aspects of drug development. By applying analytical and predictive AI, there is the potential to design smarter, more efficient protocols, ensuring greater precision in endpoint definition, improved compliance, and reduced trial timelines. This article explores some of the applications AI… Continue reading AI-Driven Protocol Digitalization: Reshaping Clinical Research