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Episode 7: A Guide to Phase 1 Clinical Trial Designs
In this QCast episode, join co-hosts Jullia and Tom as they break down Phase 1 clinical trial designs. You’ll learn exactly what happens in single and multiple ascending-dose stages, discover modern dose-escalation methods, and find out how food-effect, interaction and bioequivalence studies fit in. They’ll also share practical strategies for combining objectives, using adaptive protocols and cutting timelines without sacrificing data quality.
Key Takeaways
- Phase 1 is more than a basic safety check: it establishes pharmacokinetic and tolerability benchmarks that guide every later trial.
- Single ascending-dose studies map how a single dose behaves in the body, while multiple ascending-dose work reveals accumulation and longer-term durability.
- Adaptive escalation designs such as BOIN use real-time probability updates to find the right dose faster and with fewer volunteers.
- Early food-effect and drug to drug interaction trials determine prescribing instructions and label warnings before larger studies begin.
- Integrated protocols such as combining dose stages, meal-effect parts and interaction checks with interim review gates save time, reduce costs, and preserve trial flexibility.
🔗 Learn More & Get Support: Visit quanticate.com to explore our biometrics services and discover how we can support your next clinical trial.
📝 Episode Notes & Transcript: Find show notes, resources, and a full transcript at quanticate.com/podcast.
🔔 Stay Connected: Subscribe to QCast on Apple Podcasts, Spotify, or your favourite platform to never miss an episode.
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
- Biostatistics & Statistical Consultancy
- Statistical Programming & PK/PD Analysis
- Medical Writing & Pharmacovigilance
- Regulatory & Submission Support
- AI & Automation
- Post-Marketing Safety & Real-World Data
Quanticate is committed to delivering expertise and solutions that drive the success of clinical development worldwide.
View all episodes
By QuanticateIn this QCast episode, join co-hosts Jullia and Tom as they break down Phase 1 clinical trial designs. You’ll learn exactly what happens in single and multiple ascending-dose stages, discover modern dose-escalation methods, and find out how food-effect, interaction and bioequivalence studies fit in. They’ll also share practical strategies for combining objectives, using adaptive protocols and cutting timelines without sacrificing data quality.
Key Takeaways
- Phase 1 is more than a basic safety check: it establishes pharmacokinetic and tolerability benchmarks that guide every later trial.
- Single ascending-dose studies map how a single dose behaves in the body, while multiple ascending-dose work reveals accumulation and longer-term durability.
- Adaptive escalation designs such as BOIN use real-time probability updates to find the right dose faster and with fewer volunteers.
- Early food-effect and drug to drug interaction trials determine prescribing instructions and label warnings before larger studies begin.
- Integrated protocols such as combining dose stages, meal-effect parts and interaction checks with interim review gates save time, reduce costs, and preserve trial flexibility.
🔗 Learn More & Get Support: Visit quanticate.com to explore our biometrics services and discover how we can support your next clinical trial.
📝 Episode Notes & Transcript: Find show notes, resources, and a full transcript at quanticate.com/podcast.
🔔 Stay Connected: Subscribe to QCast on Apple Podcasts, Spotify, or your favourite platform to never miss an episode.
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
- Biostatistics & Statistical Consultancy
- Statistical Programming & PK/PD Analysis
- Medical Writing & Pharmacovigilance
- Regulatory & Submission Support
- AI & Automation
- Post-Marketing Safety & Real-World Data
Quanticate is committed to delivering expertise and solutions that drive the success of clinical development worldwide.