Once my friend said her team members cried during a meeting, i thought it was funny then. However, when I started to work in their team, I wanted to cry, too. What was the challenge? It was ISS/ ISE related work!
What is the ISS/ISE document?
ISS/ ISE known as the Integrated Summary of Safety and Integrated Summary of Effectiveness is crucial summary documents in Clinical trial industry, used to compare and contrast all the various safety and efficacy results across all the studies in the project. it is a reliable review of the benefit/risk profiles of the medication for NDA and FDA. The final documents should be presented in CTD (in Module 5).
CTD is a common format for the assembly of quality, safety and efficacy information for submission to regulatory authorities.
Why is ISS/ISE important?
Through ISS/ISE , the investigators and the authorized departments can reach a defendable statistical conclusion of an analysis of the integrated data which represents the null hypothesis and P-values and other statistical findings.
Key Point of ISS (Phase I, II, and III):
- A summary of the safety profiles from all clinical studies including:
Treatment Exposure, Adverse Event, Laboratory assessments,
Long-term adverse effects and withdrawal effects
- Pharmacologic properties: Pharmkenetics, Pharmdynmatics
- Demographic and other characteristics of the study population
- Summary of animal data important to human safety
Key Point of ISE (Phase II and III):
- P-value: An integrated summary of the data demonstrating substantial evidence of effectiveness for each claimed indication
- Treatment Factors: Evidence that supports the dosage and administration section of the labeling, including support for the recommended dosage and dose interval
- Demographic factors: Effectiveness data analyzed by sex, age, and racial subgroups, identifying any modifications of dosing for specific subgroups
- Baseline disease Factors: Effectiveness data from other subgroups of the population of patients treated, when appropriate, such as patients with different levels of severity of the disease
A Brief Introduction of ISS/ISE dataset :
- Study level
include all datasets from Phases
2. Project/Protocol level
Include all the studies
Common Techniques to Integrate ISS/ISE datasets:
1. Directly SET the study datasets:
When the study datasets have the same structures.
When different variable names represented the same value
E.G: sex=”M” , gender=”M”
3. Concatenate or Split Variables:
When the ISS/ISE dataset needs concatenate two variables or split one variable.
4. Re-derive new variables:
When the Spec changes, we need to derive new variables
5. Uniform by Unit:
When the variables represent the same thing but in different measurement systems. E.g. L= 1000mL
Happy Studying! 🍫
Thanks to 77’s notes