Integrated Summaries of Safety and Efficacy are not simply study summaries, but rather they are an analysis of results that determine the safety and effectiveness of drugs in development, including rare adverse events. The ISS summarizes safety according to data generated in all clinical trials related to the product and is considered one of the most important documents in a New Drug Application (NDA). Below are some tips from CROS NT for the successful preparation of integrated summaries.
It is very important that enough time is scheduled for the integrated summary, otherwise this could lead to a situation where increased resources have to be deployed in order to meet the timelines. This can result in higher costs and less efficiency. A thorough gathering and review of existing information is important, especially if outsourcing to a vendor. Information such as protocols, Statistical Analysis Plans (SAPs), annotated CRFs, coding dictionaries, define.xml etc need to be made available at the outset to avoid unnecessary delay.
Implementing CDISC standards
As regulatory agencies are moving towards making CDISC compliant data sets mandatory, it makes sense for companies to implement these standards for Integrated Summaries. If you have decided to make all data sets CDISC compliant there is usually a lot of mapping work to be done in order to achieve consistent formats. Bespoke macros may become the best option and with good planning and use of repetitive code a lot of efficiencies can emerge.
What questions should Sponsors ask before planning and preparation of ISS/ISE?
– Is there full specification available on all of the studies (SAP, eCRF, data set specs, CSR etc…)?
– What level of similarity is there in the data sets for the individual studies? Was the same vendor used and are study designs similar?
– Should Sponsor or vendor SOPs be used to conduct the work?
– What are the rules for traceability?
– Will there be Sponsor or Vendor contacts available who are familiar with each of the studies?
If you would like the full article, “Tips for Successful Integratd Summaries (ISS/ISE) Preparation” with statistical methodology and programming advice for ISS/ISE preparation, please email us at firstname.lastname@example.org.
CROS NT and Integrated Summaries
CROS NT has completed over 1,000 studies in a wide range of therapeutic areas, and several study programmes have included the preparation of Integrated Summaries of Safety and Efficacy for both the EMA and FDA. We have an expert team of methodological biostatisticians and statistical programmers with particular expertise in trial design, data analysis and implementing and mapping CDISC standards. Our statisticians offer consultancy on a case-by-case basis, including methodological guidance for ISS/ISE preparation. CROS NT is a CDISC Gold Member meaning it has constant access to new data standards and new documentation regarding CDISC standards.