Optimization of Adaptive Design in Clinical Research and Inspiration for Traditional Chinese Medicine Research and Development
10.13422/j.cnki.syfjx.20240822
- VernacularTitle:适应性设计在临床研究中的优化及中医药研发应用
- Author:
Ruiting LYU
1
;
Bingqing LU
1
;
Wenyuan LI
1
;
Jianyuan TANG
1
Author Information
1. Hospital of Chengdu University of Traditional Chinese Medicine，Chengdu 610075，China
- Publication Type:Journal Article
- Keywords:
adaptive design;
clinical trials;
optimization of trials;
traditional Chinese medicine;
innovative research and development;
holistic concept;
treatment based on syndrome differentiation
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2024;30(22):110-119
- CountryChina
- Language:Chinese
-
Abstract:
In recent years， adaptive design has gradually emerged in clinical trials， gaining widespread application and expansion. Compared with traditional randomized controlled trials， appropriate adaptive design can save time and resources to some extent， improve the validity of the trial results and strength of the evidence， align better with ethical requirements， and facilitate subsequent drug market research. However， due to the greater flexibility of adaptive design， controlling type Ⅰ error rates and truly enhancing research efficiency are challenging aspects of its application. Therefore， the normative application and optimization of adaptive design in research deserve early focus， including adhering to good adaptive design principles， conducting rigorous pre-design planning， scientifically applying various statistical methods such as Bayesian dynamic models and simulation methods， and utilizing monitoring tools like monitoring committees to ensure the scientific integrity of the research process. Moreover， the flexibility of adaptive design aligns well with the practical realities of traditional Chinese medicine （TCM） clinical practice. The main characteristics of TCM， such as the holistic concept and treatment based on syndrome differentiation， determine that TCM provides a dynamic and personalized treatment plan. In contrast， the traditional fixed development approach of western medicine limits the application of "human experience" in TCM. To address this bottleneck in TCM research and development， the innovative use of adaptive design， a modern scientific theory and methodology with multiplicity and variability， offers a feasible new approach for TCM clinical research and the innovation of Chinese herbal medicine. By learning from successful cases such as the first Food and Drug Administration （FDA）-approved oral botanical drug， Crofelemer， researchers can explore optimal solutions for adaptive design in clinical research protocols and its role in the "three-combination" evaluation system for Chinese herbal medicines， further refine trial design， clarify key trial points， and develop innovative research and development applications that adapt to the clinical positioning of TCM and highlight the characteristics and advantages of TCM， paving the way for the clinical efficacy， pharmacological mechanism exploration， and post-market efficacy evaluation of Chinese herbal compounds.
