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Quanticate - Clinical Research Organization

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Integrated Summaries of Safety & Efficacy

Ensure a successful regulatory submission when drawing conclusions from multiple studies.

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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. Standardization across data is mandatory as regulatory bodies seek CDISC standards within your submission. 

Free Guide: How to Plan a Successful ISS/ISE

Quanticate has long legacy of producing 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 the best way to combine 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 are both important tools - 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. 

Integrated Summary of Safety (ISS)

Within ISS, the safety results of different studies on the same compound are pooled together.

Advantages of an ISS include:

  • Identification of common related adverse events (AEs)
  • Identification of common serious adverse events (SAEs)
  • Identification of safety concerns that may not be apparent from a single study
  • Allowing an assessment of safety in subgroups if sample sizes are sufficiently large

 

Integrated Summary of Efficacy (ISE)

Within ISE, the efficacy results from different studies conducted on the same compound are combined.

The advantages of ISE include:

  • Enable the assessment of efficacy in subgroups (e.g. paediatrics)
  • Enable the assessment of the efficacy of secondary endpoints, which may have been under‑powered in individual studies
  • Allow detailed comparison of results versus a comparator drug
  • Allow assessment of the efficacy of repeat doses
  • Enable the dose-response profile to be more accurately estimated
  • Allow any changes that may have occurred in efficacy over the lifetime of the drug development to be investigated
  • Help to address why results for a particular study may be inconsistent with the results of other studies
  • Enable the assessment of the sensitivity of results to different methodologies for defining endpoints, or different methodologies for handling missing data

We offer three levels of ISS/ISE service:

Choose the best option that suits you and your trial.

Standard Service

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.

Standard Service includes:

  • ISE and ISS Statistical Analysis Plan
  • Strategy for Pooling Data including Dataset Specifications
  • Combined ADaM datasets
  • Analyses, summary outputs and figures by subgroups and sub-populations

Data Quality Oversight Service

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.

Data Quality Oversight Service includes:

  • Statistical Analysis Plan for Comparison of Individual Studies
  • Import study data into DQO tools
  • Analyses conducted in CluePoints and/or JMP
  • Unanticipated study conditions, such as site-related differences in standard care identified if possible
  • Further exploratory analyses conducted if required
  • Report written for inclusion into Module 5 of CTD

Regulatory Submission Review

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.

Regulatory Submission Review Service includes: 

  • Assessment of data and analysis quality
  • Evaluation of efficacy
  • Review of study design and endpoints
  • Review of statistical methodologies used
  • Assessment of the generalisability of the results from review of Sub-groups, sub-populations and differences between studies
  • Recommendations for further analyses to address concerns and issues

Don't let your data let you down

 

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Resources to ensure you have a successful regulatory submission when drawing conclusions from multiple studies

WHITEPAPER

Discover how Medical Writers should contribute towards a quality ISS/ISE
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WHITEPAPER

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CASE STUDY

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BLOG

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