Welcome to From Fixed to Flexible: Your Guide to Adaptive Designs and Master Protocols!
This repository is a collaborative space for learning about and working with adaptive designs and master protocols in clinical trials. Our primary goal is to create and present a practical master protocol incorporating adaptive design principles. Traditional clinical trials often follow a fixed design, but modern approaches are embracing flexibility and efficiency. Here's a quick introduction to the key concepts:
Adaptive Designs: These are clinical trial designs that allow for pre-planned modifications to aspects of the trial based on accumulating data. This could include changes to sample size, treatment arms, or patient populations, all while maintaining the trial's validity and integrity. Adaptive designs enhance efficiency by allowing trials to respond to emerging data, potentially leading to faster and more conclusive results.
For instance, one type of adaptation is extending the recruitment period. If the initial recruitment rate is slower than anticipated, an adaptive design might allow for a pre-planned extension of the recruitment timeline to reach the desired sample size, ensuring the study has sufficient power to answer its research question. Other common adaptations include changes to treatment arms (dropping ineffective arms, adding new arms), sample size adjustments based on interim efficacy or futility, and modifications to patient populations based on emerging biomarker data.
Master Protocols: Master protocols are overarching frameworks designed to evaluate multiple treatments or answer multiple questions within a single, streamlined structure. They are particularly valuable for studying various therapies for a single disease (like in oncology) or a single therapy across multiple diseases. Importantly, while master protocols are not inherently adaptive, they frequently utilize adaptive design elements to further enhance their efficiency. This allows for seamless transitions between different research questions and treatment evaluations within the same protocol.
Precision Medicine and the Need for Flexibility: In the era of precision medicine, we are increasingly focused on targeted therapies and understanding how treatments work in specific patient subgroups. This necessitates the ability to conduct simultaneous multi-clinical trials and efficiently adapt our research as we learn. Master protocols with embedded adaptive designs are ideally suited for this landscape, enabling us to investigate multiple treatments concurrently, personalize approaches based on patient characteristics, and accelerate the development of effective therapies.
In this repository, we are studying these powerful methodologies, particularly in the context of oncology, and aiming to develop and present a practical master protocol incorporating adaptive design principles. However, our vision extends to exploring the broader application of these flexible approaches across diverse clinical trial settings. Join us as we move from fixed to flexible clinical trial designs!
"From Theory to Practice: Embracing Flexible Clinical Trials"
Our journey is to move beyond traditional fixed designs and actively implement adaptive designs and master protocols in clinical research. We aim to:
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Deepen our understanding: Thoroughly study the principles and practical applications of adaptive designs and master protocols. To solidify our learning, participants will have the opportunity to summarize and present study materials to the group, potentially two or three times throughout the project. To further share our knowledge, your presentation materials, prepared in Markdown format, will be published on our project's GitHub Pages. Please ensure your presentation materials are original summaries and avoid direct copy-pasting from sources to respect copyright and develop your summarizing skills. This will be a valuable way to deepen your own understanding, contribute to our shared resource, and share insights with fellow contributors and the wider community.
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Create and contribute: Develop a practical master protocol incorporating adaptive design principles and share it openly with the research community.
Join us in making clinical trials more efficient and responsive!
| Role | Name | Main interest | |
|---|---|---|---|
| Project Manager | Sang Ho Park | https://www.linkedin.com/in/shstat1729/ | Observational study, Continuous glucose monitoring, Clinical trial |
| Member | SooYoung Kwak | https://www.linkedin.com/in/systat/ | Medical device regulation |
| Member | Chungsoo Kim | https://www.linkedin.com/in/chungsoo-kim-42419b175/ | pharmacoepidemiology, medical informatics, health data science, cardiovascular disease, chronic disease |
| Member | Jeongsun Park | https://www.linkedin.com/in/sun-park-861272138/ | |
| Member | Christina Obeid | https://www.linkedin.com/in/christina-obeid-14158b272/ | cybersecurity, data science, and backend dev |
| Member | HeeSeok YOO | https://www.linkedin.com/in/%ED%9D%AC%EC%84%9D-%EC%9C%A0-763999245/ |
| Date | Contents | Presenter | Github Pages |
|---|---|---|---|
| 2025/03/12 | OT | Sang Ho Park | |
| 2025/03/19 | Introduction to Clinical Trial Research | Sang Ho Park | Intro to Clinical Trial Research |
| 2025/03/24-2025/03/30 | Magical Week 1 | ||
| 2025/04/02 | History of Clinical Trial Research | Christina Obeid | History of Clinical Trials |
| 2025/04/09 | Characteristics and Principles of Adaptive Trial Designs | Jeongsun Park | Characteristics and Principles of Adaptive Trial Designs |
| 2025/04/16 | Common Types of Adaptive Trial Designs | Chungsoo Kim | Common Types of Adaptive Trial Designs |
| 2025/04/23 | Clnicial Trial Simulations | ||
| 2025/04/28-2025/05/03 | Magical Week 2 | ||
| 2025/05/07 | Characteristics and Principles of Master Protocols | ||
| 2025/05/14 | Platform Trials | ||
| 2025/05/21 | Basket Trials and Umbrella Trials | ||
| 2025/05/28 | Case Studies of Adaptive Trial Designs and Platform Trials | ||
| 2025/06/04 | Case Studies of Basket Trials and Umbrella Trials | ||
| 2025/06/11 | Standards and Guidelines for and Common Misconceptions of Adaptive Trial Designs and Master Protocols | ||
| 2025/06/18 | Practical Considerations for Adaptive Trial Designs and Master Protocols | ||
| 2025/06/25 | Protocol presentation | ||
| 2025/07/02 | Protocol presentation |
- Main Textbook: You should buy and study this material.
- Guide for writing protocol; SPIRIT 2013 checklist: You should write a clinical trial protocol according to SPIRIT 2013 checklist.
- Master protocol of FDA Guidance: Additional
- Adaptive design of FDA guidance; Drug and Biologics: Additional
- Adaptive design of FDA guidance; Medical devices: Additional
Join us in this project!
- Project Application: Link to Application Form We are preparing an application form to help us understand your interests and how you'd like to contribute. More details about the application process will be provided within the application form itself. Since this project's working language is English, we welcome participants who are willing to communicate and learn in English. In your application form, please express your willingness to engage in English, both in writing and verbally, throughout your participation. We are happy to support your English language journey within the project.
- Community Language: While the broader PseudoLab community uses Korean, this project's primary working language is English. Please submit your application in English. If you encounter Korean language content within the application form or in the wider PseudoLab community outside of this project, you can utilize translation tools like Google Translate.
- Meeting Time: We hold regular project meetings Wednesday at 21:00 KST (Korean Standard Time) in PseudoLab Discord #Room-YB channel (online).
Observe Our Sessions! You are welcome to observe our sessions and learn more about the project before applying or actively participating. Here are a few ways to do so:
- Discord (Weekly Meetings): Join our Discord channel
#Room-YBWednesday at 21:00 KST to listen in on our regular project meetings. - Magical Week Events: We will be hosting special "Magical Week" events related to the project. You can observe or attend during either Magical Week 1 (March 24-30) or Magical Week 2 (April 28-May 3) (Please check for updates for each event).
- Pseudo Lab Conference (Seoul): Keep an eye out for opportunities to observe project presentations or sessions at upcoming Pseudo Lab conferences held in Seoul, South Korea. Details will be announced within the community.
2025 Key Performance Indicator (KPI)
| Indicator | Aim | Achievement Status |
|---|---|---|
| Github Star | 50 | |
| Study Material Summary in Github Pages | 100% | 0% |
| Clinical Trial Protocol Share | 80% | 0% |
From Fixed to Flexible: Your Guide to Adaptive Designs and Master Protocols is developed as part of Pseudo-Lab's Open Research Initiative. Special thanks to our contributors and the open source community for their valuable insights and contributions.
Pseudo-Lab is a non-profit organization focused on advancing machine learning and AI technologies. Our core values of Sharing, Motivation, and Collaborative Joy drive us to create impactful open-source projects. With over 5k+ researchers, we are committed to advancing machine learning and AI technologies.
This project is licensed under the MIT License.