Avanamd Healthcare
Integrated Summaries of Safety & Efficacy (ISS/ISE)
Are you planning a regulatory submission and need to prepare an Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) for your Common Technical Document (CTD)?
Preparing integrated summaries can be challenging because each clinical development program involves different studies, datasets, endpoints, and analysis requirements. Combining results across studies requires careful planning, consistent data structures, and appropriate statistical methods. Standardization of clinical data, including the use of applicable CDISC standards, is an important consideration when preparing regulatory submissions.
Avanamd Healthcare supports clinical research organizations and pharmaceutical companies with biostatistics, statistical programming, clinical data management, and medical writing services to help support the preparation of integrated safety and efficacy analyses.
Planning a Successful ISS/ISE
Developing an effective ISS/ISE begins with understanding the clinical development program, identifying relevant studies, evaluating data compatibility, and defining suitable analysis methods. Early planning can help identify differences in study design, patient populations, treatment exposure, safety reporting, and efficacy endpoints before data integration begins.
Avanamd Healthcare supports the statistical and programming activities involved in combining clinical study data, with a focus on consistency, traceability, and reliable analysis. Our services can also support the preparation and presentation of integrated findings for inclusion in the CTD, according to the agreed project scope.
ISS and ISE analyses can provide a broader view of a medicine's safety and efficacy by evaluating results across multiple studies. When appropriately designed, these analyses may help identify patterns, explore subgroup outcomes, assess treatment effects, and support evidence-based regulatory review.
Why early planning matters: Identifying data differences, defining analysis populations, and selecting appropriate statistical methods early in the process can help support consistent, traceable integrated analyses.
Integrated Summary of Safety (ISS)
An Integrated Summary of Safety combines and evaluates safety results from relevant clinical studies of the same investigational medicine. By reviewing safety information across studies, researchers can assess adverse events, serious adverse events, treatment exposure, and other relevant safety measures across a broader population.
Key Benefits of an ISS
- Identifying patterns in common adverse events (AEs).
- Evaluating serious adverse events (SAEs) across studies.
- Exploring potential safety concerns not apparent in an individual study.
- Supporting safety assessments in relevant subgroups when sufficient data are available.
- Evaluating safety findings across different treatment exposures and study populations.
- Providing integrated safety information to support regulatory review.
Avanamd Healthcare supports the data preparation, statistical programming, analysis, and reporting activities required for integrated safety assessments, subject to the needs of the development program.
Integrated Summary of Efficacy (ISE)
An Integrated Summary of Efficacy combines and evaluates efficacy results from relevant clinical studies of the same medicine. It can provide a broader assessment of treatment effects by examining primary and secondary endpoints, comparing results across studies, and exploring relevant patient subgroups.
Key Benefits of an ISE
- Assessing treatment efficacy across relevant patient subgroups, where supported by the study data.
- Exploring secondary endpoints that may have limited statistical power in individual studies.
- Supporting comparisons between treatment groups and appropriate comparator treatments.
- Evaluating efficacy across different doses and treatment regimens.
- Investigating dose-response relationships.
- Examining potential changes in treatment effects across the clinical development program.
- Exploring reasons for inconsistent results between studies.
- Assessing sensitivity to alternative endpoint definitions and methods for handling missing data.
Avanamd Healthcare supports integrated efficacy analysis through statistical methodology, programming, data review, and clear presentation of study findings. The analytical approach is tailored to the study designs, available data, clinical objectives, and applicable regulatory requirements.
Supporting Regulatory Submission Preparation
Reliable ISS and ISE preparation requires collaboration between biostatisticians, statistical programmers, clinical data management teams, and medical writers. Avanamd Healthcare brings together these service areas to support the integration, analysis, and presentation of clinical evidence.
Our objective is to help organizations develop consistent, traceable, and well-documented integrated analyses that support regulatory submission activities and the evaluation of a medicine's safety and efficacy throughout its clinical development program.