Adaptive Platform Trials: Transforming Clinical Research with OpenClinica
Adaptive platform trials (APTs) are transforming the way clinical research is conducted. Unlike traditional trials that evaluate one treatment at a time under a fixed protocol, APTs use a single, master protocol to evaluate multiple therapies simultaneously. They’re built for flexibility, allowing researchers to:
- Add or drop treatment arms
- Adjust patient randomization based on real-time outcomes
- Shift control groups when a promising therapy emerges
- Seamlessly transition between trial phases
Image Source: https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.121.058113
This dynamic structure means better use of data, fewer patients exposed to ineffective treatments, and faster insights into what works.
It’s no wonder APTs are gaining traction. They were instrumental during the COVID-19 pandemic, powering major efforts like:
- REMAP-CAP, testing therapies for severe respiratory infections
- RECOVERY, which helped identify effective COVID-19 treatments in the UK
- ACTIV-4, designed to evaluate multiple COVID-19 therapies in parallel
Now, APTs are helping accelerate research in areas like ALS, Alzheimer’s, and most notably, breast cancer—where the I-SPY 2 trial is leading the way.
I-SPY 2: A Model for Modern Oncology Trials
Led by Quantum Leap Healthcare Collaborative, I-SPY 2 is one of the first and longest-running adaptive platform trials in existence. Focused on finding better, more personalized breast cancer treatments faster, I-SPY 2 uses an interventional, randomized APT design to test multiple drugs and combinations efficiently.
The I-SPY2 statistics are:
- Participants: 4,906
- Amendments: 37
- Agents Evaluated: 25
- Agents Receiving Accelerated Approval: 3
- Forms Automated: 95,456
- Data Values Automated: 20 million+
This trial demonstrates the significant potential of the adaptive platform model when applied to a high-need, high-impact therapeutic area like oncology.
OpenClinica’s Impact on the Groundbreaking I-SPY 2 Trial
At OpenClinica, we’re honored to power one of the most transformative breast cancer trials in history: I-SPY 2. When Quantum Leap Healthcare Collaborative transitioned I-SPY 2 to the OpenClinica platform, they gained a future-ready infrastructure capable of meeting the demands of an adaptive, ever-evolving trial model.
I-SPY 2 is a clinical trial unlike any other—a dynamic platform that has evaluated 25 investigational agents, with:
- 12 therapies advancing beyond Phase 2
- Three achieving accelerated FDA approval
- One earning Breakthrough Therapy Designation
Behind this success is OpenClinica’s suite of solutions, purpose-built to support the speed, scale, and sophistication of I-SPY 2. Our technology enables:
- Effortless protocol adaptations to accommodate new treatment arms and evolving strategies
- Operational agility, including mid-trial eligibility adjustments and automated re-consenting workflows
- Seamless EHR integration for direct, automated data capture at the point of care
- Modular, interoperable architecture that grows with trial complexity and site expansion
As I-SPY 2 continues to shape the future of precision oncology, OpenClinica remains a committed partner, powering innovation, improving efficiency, and ultimately helping bring lifesaving treatments to patients faster.
To read the full OpenClinica + I-SPY 2 case study, click here.
The Many Faces of Adaptation in Platform Trials
Adaptive platform trials aren’t just one thing—they involve multiple layers of adaptation:
- Design Adaptations
– Add, drop, or modify treatment arms
– Escalate doses
– Seamlessly transition between phases - Randomization Adaptations
– Use response-adaptive randomization
– Change allocation ratios
– Stratify based on patient-specific data - Operational Adaptations
– Modify eligibility criteria mid-trial
– Adjust endpoints as evidence evolves
– Re-consent patients as protocols change
These forms of adaptation require a flexible, configurable, future-proof platform, which most legacy EDC systems struggle to provide. OpenClinica’s modular and interoperable design is purpose-built to meet these challenges.
Why Adaptive Platform Trials Are the Future
The benefits of APTs are too compelling to ignore:
- Faster access to promising new treatments
- Reduced patient exposure to ineffective therapies
- Improved safety monitoring
- More data, less time, and fewer resources
And perhaps most importantly, they’re more patient-centric. APTs provide participants with more treatment options within the same trial framework, thereby reducing disruption and increasing engagement.
Looking Ahead
As the clinical research world moves toward smarter, faster, and more flexible trials, adaptive platform designs will only become more prevalent. At OpenClinica, we’re committed to equipping researchers with the tools and support they need to lead this transformation.
We’re honored to be part of I-SPY 2’s success and excited to support many more adaptive platform trials that will change lives.
To learn more about how OpenClinica supports APTs, or to explore the I-SPY 2 case study, click here.