GUIP1
"GUIP1" is an R Graphical User Interface (GUI) to support dose escalation strategies in Phase 1 cancer clinical trials. The primary goal of such trials is to identify the maximum tolerated dose, which is crucial for ensuring the safety and efficacy of new cancer treatments. To achieve this, GUIP1 incorporates several model-guided adaptive designs, including the Continual Reassessment Method (CRM), Escalation With Overdose Control (EWOC), Time-to-Event Continual Reassessment Method (TITE-CRM), and Time-to-Event Escalation With Overdose Control (TITE-EWOC).
Key Features and Functionalities:
- Comprehensive Dose Escalation Methods: GUIP1 integrates multiple dose escalation strategies, including CRM and EWOC, as well as their time-to-event counterparts (TITE-CRM and TITE-EWOC), catering to a wide range of clinical trial requirements.
- Based on R Packages: The tool utilizes the dfcrm and bcrm R packages for CRM implementations, while TITE-EWOC has been specifically developed for this interface, ensures a robust statistical foundation for trial designs.
- Graphical User Interface: Built using the TCL/TK programming language and compatible with R software libraries, GUIP1 provides a user-friendly interface that simplifies the complex process of managing dose escalation in clinical trials.
- Real-Time Trial Management and Simulation: Users can simulate or conduct and manage phase I clinical trials in real-time, with features for file management and automatic backup of study or simulation results, enhancing study traceability and data integrity.
Accessibility for Beginners: GUIP1 is designed to be accessible even to beginners in R. It simplifies the application of advanced dose escalation methods without requiring extensive programming knowledge.
Topic
Preclinical and clinical studies;Oncology;Statistics and probability
Detail
Operation: Phasing;Modelling and simulation;Regression analysis
Software interface: Desktop application, Library
Language: R
License: GNU General Public License >= version 2
Cost: Free with restrictions
Version name: 0.1.0
Credit: French National Cancer Institute.
Input: -
Output: -
Contact: C. Mollevi Caroline.Mollevi@icm.unicancer.fr
Collection: -
Maturity: -
Publications
- GUIP1: a R package for dose escalation strategies in phase I cancer clinical trials.
- Dinart D, et al. GUIP1: a R package for dose escalation strategies in phase I cancer clinical trials. GUIP1: a R package for dose escalation strategies in phase I cancer clinical trials. 2020; 20:134. doi: 10.1186/s12911-020-01149-3
- https://doi.org/10.1186/S12911-020-01149-3
- PMID: 32580715
- PMC: PMC7469913
Download and documentation
Source: https://github.com/ddinart/GUIP1
Documentation: https://github.com/ddinart/GUIP1/tree/master/man
Home page: https://github.com/ddinart/GUIP1
Links: https://github.com/ddinart/GUIP1/tree/master/vignettes
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