Time to response of two or more treatments
In the context of many clinical trials, particularly phase III, researchers are interested in comparing the two treatments under evaluation, in terms of response time, i.e. the time until the appearance of a complete or partial response to the drug.
Examples: In these studies, healthcare professionals record for each participant whether they experience: complete response (CR), partial response (PR) or progression of disease (PD), as well as the time (from the start of the study) in which they develop the respective condition, and then compare the treatments under investigation, in terms of response time, that is, the time until a complete or partial response to the treatment appears.
The problem
In the context of many clinical trials, particularly phase III, researchers are interested in comparing the two treatments under evaluation, in terms of response time, i.e. the time until the appearance of a complete or partial response to the drug. For example, in these studies healthcare professionals record for each participant whether they experience: complete response (CR), partial response (PR) or progression of disease (PD), as well as the time (from the start of the study) in which they develop the respective condition, and then compare the treatments under investigation, in terms of response time, that is, the time until a complete or partial response to the treatment appears.
The purpose
Indication of the most effective treatment in terms of response time, i.e. the time until a complete or partial response to the treatment occurs.
The solution
With the use of the appropriate statistical methodology (Log rank test) and after the test of the assumptions, a comparison will be made between the two or more compared treatments, in order to enable the user to evaluate which of the treatments under investigation is more effective in terms of response time, i.e. the time until a complete or partial response to treatment occurs.
The benefit
Healthcare professionals will be able to easily, quickly and without having prior statistical knowledge, evaluate the effectiveness of a treatment they are interested in, in terms of response time, i.e. the time until the appearance of a full or partial response to the treatment.
Indicative presentation of the data needed
- The first column of the data file must contain the patient code (e.g. Unique Patient Code). In case there is no patient code in the user's data file, then in the first column he should add a serial number.
- The second column should contain which medication the participant received (e.g. 0: Standard treatment, 1: Suggested treatment).
- The third column should contain the information regarding the response of each participant (e.g. 0: Progression of the disease, 1: Complete/Partial response) after a certain period of time of administration of each treatment (e.g. 6 months).
- The fourth column should contain the date each participant joined the study.
- The fifth should contain the date on which each participant had a complete or partial response to treatment, or the date of their last follow-up.
- The sixth column should contain the information about whether the participant showed a full/partial response or not.
Note: The columns that will contain the date should be in the format DD/MM/YYYY.
Table 1. Indicative table of input data from the application user
|
Patient Code |
Treatment |
Date of entry into the study |
Date of complete/partial response or date of last follow-up |
Full/Partial response |
|
1 |
Standard |
01/10/2021 |
20/10/2021 |
Yes |
|
2 |
Standard |
15/10/2021 |
01/11/2021 |
No |
|
3 |
Standard |
05/10/2021 |
30/06/2022 |
No |
|
4 |
Suggested |
09/10/2021 |
25/04/2022 |
Yes |
|
5 |
Suggested |
18/10/2021 |
30/06/2022 |
No |
|
6 |
Suggested |
27/10/2021 |
22/03/2022 |
Yes |
System Prerequisites:
- Toolbox accepts xlsx or csv files.
- The two variables that declare the dates must not have missing data.
- The partial/complete response variable must not contain missing data.
- The variable denoting the treatment must not contain missing data.
Output:
After the data input by the user and after a short period for the automated analysis to be completed, a report of the results and the statistical methods used is extracted from the system.
Note: For any clarification you need regarding the content of the use case or any information related to the collection or validity of your data please contact us.
