Safety analysis of two or more treatments
In the context of randomized clinical trials, healthcare professionals are required to evaluate the safety of a new suggested therapeutic treatment and for this reason compare it with other pre-existing treatments, in terms of the occurrence of an adverse event after a certain period of administration.
Examples: A research group wishes to develop a new treatment and evaluate its impact on major adverse cardiovascular events, a combination of myocardial infarction, stroke, and revascularization. For this reason, he wishes to compare the new treatment, both with the pre-existing one used in clinical practice, and with the placebo, in order to prove the necessity of the new treatment as well as its safety in terms of the occurrence of the above combined adverse event after 6 months of treatment administration.
The problem
In the context of randomized clinical trials, healthcare professionals are required to evaluate the safety of a new suggested therapeutic treatment and for this reason compare it with other pre-existing treatments, in terms of the occurrence of an adverse event after a certain period of administration . For example, a research group wishes to develop a new treatment and evaluate its impact on major adverse cardiovascular events, a combination of myocardial infarction, stroke, and revascularization. For this reason, he wishes to compare the new treatment, both with the pre-existing one used in clinical practice, and with the placebo, in order to prove the necessity of the new treatment as well as its safety in terms of the occurrence of the above combined adverse event after 6 months of treatment administration.
The purpose
Indication of the safest therapeutic treatment in terms of the occurrence of a specific adverse event, after a specific period of treatment administration.
The solution
With the use of the appropriate statistical methodology (Pearson Chi-square test, Fisher's exact test) and after the test of the assumptions, the two or more treatments that the user will insert in the algorithm will be compared in terms of their safety, regarding the occurrence of a specific adverse event after a period of administration.
The benefit
Healthcare professionals will be able to easily, quickly and without having prior statistical knowledge, compare two or more therapeutic treatments they wish in terms of the probability of occurrence of a specific adverse event after a certain period of administration, and thus reach a conclusion on the safer 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 the information about the treatment to which each person has been subjected (e.g. 0: Placebo, 1: Standard treatment, 2: New Suggested Treatment).
- The third column should contain the information on whether or not each subject experienced the specific adverse event of interest to the investigator (e.g. occurrence of a major adverse cardiovascular event after 6 months of treatment - 0: No , 1: Yes).
Table 1. Indicative table of input data from the application user
|
Patient Code |
Treatment |
Full/Partial response |
|
1 |
Placebo |
Yes |
|
2 |
Placebo |
Yes |
|
3 |
Placebo |
Yes |
|
4 |
Placebo |
No |
|
5 |
Standard treatment |
No |
|
6 |
Standard treatment |
No |
|
7 |
Standard treatment |
Yes |
|
8 |
Standard treatment |
Yes |
|
9 |
Suggested treatment |
Yes |
|
10 |
Suggested treatment |
No |
|
11 |
Suggested treatment |
No |
|
12 |
Suggested treatment |
No |
System Prerequisites:
- Toolbox accepts xlsx or csv files.
- The variable denoting the treatment must not contain missing data.
- The variable that indicates the occurrence or not of an unwanted event must not contain incomplete data.
- If in either of the above two cases there are missing data, then the subject is removed from the analysis.
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.
