CTD Literature: The Design Structure Of Clinical Trial

4.2. Design structure of clinical trial
In designing structure of clinical trial, researchers are trying to specify characteristics of trials (that will be more discussed in the following) with considering intervention implementation constraints (e.g., time, financial, and ethical constraints) to maximize the precision and stability of the obtained results about the intervention effect. Although this aspect of clinical trials has received the most attention in the CTD literature, optimization approaches have rarely been used in these studies. Thus, the optimal design of trials creates areas of opportunity for using numerous methodologies and solution techniques that are provided by IE/OR methods. The design of clinical trials structure has
This may lead to bias in the trial analysis, thus it is expected that future studies will develop statistical models which consider both time and clustering effects to calculate the power of trials. Considering other factors - such as the number of randomization steps – which can influence the trial’s outcomes, is beneficial to increase the accuracy of the presented inferences. Due to the dependency of the intervention effect on time and clustering, proposing a method to extract the intervention effects are highly dependent on the trial’s characteristics. Therefore, presenting an optimization procedure to simultaneously determine trial’s characteristics and analysis method is definitely worthwhile. However, researchers should be kept in mind that such models can be complex from a mathematical
Conclusion
As above discussed, all three aspects of the CTD problems are suffering from lack of optimization procedures, so IE/OR methods can make a significant contribution to this field in future. However, the dissemination of OR methodologies to the healthcare community, especially clinical trials, is an important challenge that has not been addressed well. Furthermore, some statistical theories and machine learning techniques should combine with IE/OR tools to accurately model some of the CTD problems. This lead to the additional complexity of using optimization approaches in this field.
Some of the open research questions that are discussed throughout this report are as follow (it should be noted that the practically and theoretically applicability of these suggested future researches have not been reviewed in detail, and are only basic ideas):
1) Presenting an optimization procedure to determine and modify the secondary characteristics of an adaptive clinical trial
2) Comparing possible options for the primary characteristics by analytical