Episode 38: Observational Studies in Clinical Trials

In this QCast episode, Jullia and Tom explore observational studies and why they remain such an important part of the evidence base in drug development. They explain what makes an observational study different from an interventional trial, how routine care data can be used to answer practical research questions, and why the value of these studies depends so heavily on clear design, data quality, and careful analysis.

Key Takeaways

• Understand observational studies as non-interventional research, where treatment decisions happen through usual care rather than study assignment.
• Use observational studies to examine broader populations, longer-term outcomes, treatment patterns, and other real-world questions.
• Plan for bias and data limitations early, because baseline differences, missing data, and timing issues can affect the conclusions.

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📝 Episode Notes & Transcript: Find show notes, resources, and a full transcript at quanticate.com/podcast.
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About Quanticate

Founded in 1994, Quanticate is a biometrics-focused CRO with over 30 years' experience delivering expert clinical and post-marketing data services worldwide. Specialising in the collection, management, standardisation, analysis, and reporting of data, we support pharma and biotech companies globally with high-quality solutions for clinical development. We specialise in:

• Clinical Data Capture & Management
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