Are you planning a regulatory submission and need to include an Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) within your Common Technical Document (CTD)?
Due to the unique nature of each submission, understanding the best way to plan your integrated summaries can be difficult. Challenges arise when combining multiple studies to review the safety and efficacy of an IND/NDA. Standardisation across data is mandatory as regulatory bodies seek CDISC standards within your submission.
Quanticate has produced Integrated Summaries for a wide range of clients over the years. As a data-focused CRO, Quanticate has the programmers and statisticians to provide expert advice on combining of data for an ISS/ISE, including help in identifying how time to approval can be reduced by careful up-front planning.
An ISS or ISE is an important tool as the larger sample size of data allows for easier identification of any correlations and trends. This allows for better-presented and unbiased data for regulatory submissions as the regulatory authorities state ISE and ISS are critical components of a submission. After combining data for an ISS/ISE, support in the ISS/ISE preparation within the CTD can be provided by our medical writing department.
Within ISS, the safety results of different studies on the same compound are pooled together. Advantages of an ISS include:
Within ISE, the efficacy results from different studies conducted on the same compound are combined. Therefore the advantages of ISE include :
Objective: to conduct pooled analyses of data from more than one study by pooling subject-level data or pooling common outcomes from individual studies.
To demonstrate evidence of effectiveness across different sub-groups such as demographic characteristics such as sex, age and racial sub-groups and other relevant sub-populations like patients with different levels of severity of disease.
Objective: to compare the results from individual studies.
To demonstrate the strength of statistical evidence from the consistency of the findings across individual studies especially for pre-specified primary endpoints. Any important differences in outcome need to be discussed and displayed and if possible, factors underlying the differences be identified. Quanticate would use our Data Quality Oversight tools to help identify inconsistencies across studies and underlying factors associated with these differences.
Objective: describe key statistical issues and findings that impact the demonstration of efficacy and/or safety based on each study and on the collective evidence
This paper looks at how a Medical Writer should contribute to the production of a quality ISS/ISE. It follows a previous white paper on the role of Statisticians and Programmers in the production of integrated summaries.