ISSR is a comprehensive and detailed analysis about the safety of drugs in development. Although it is termed a summary, it includes a well-described report involving a lot of information about the developing drug's safety. ISSR is most often needed by pharmaceutical organizations during the submission phases. This can be during the submission to of a new drug application to the regulator or during the submission for getting marketing approval since at both stages the regulator needs to check for the safety of the drug.
A typical ISSR
Usually, an ISSR in clinical research must consist at least the following points in its plan:
- A summarized report of the individual clinical studies
- Extent of patient exposure during treatment
- Patient demographics and individual characteristics
- Adverse events - total number of events, severity of each event, and responses during each event
- Clinical laboratory assessments
- Patient narratives or suggestions or opinions
Why prepare an ISSR
An ISSR compiles all information about safety issues in drug development and in clinical trials into one single point of verification. This can serve as a single source for physicians, clinical researchers, or managers to refer in case they want information regarding an event in the trials. An ISSR can help in a comprehensive check of the clinical trial results to discover any events that may not have been visible with individual trials. Identification of such events can help in the improvement in trials which in turn can lead to higher chances of clearance by regulators.
Preparing an ISSR
Medical writer, statisticians, and programmers are three integral resource persons needed to draft a reliable and solid ISSR. Together they ensure that an ISSR is created on time and within budget constraints.
Statisticians/biostatisticians are one of the important resource person needed to prepare a reliable ISSR. They outline the template or draft of the ISSR and provide for the analysis of the ISSR. This is called a statistical analysis plan (SAP). The SAP will have different subsets under it which cater to demographic specific analysis for instance. Due to their major role, statisticians must be involved by the sponsor during pre-submission meetings before submission to the regulators. Their inputs on the statistical aspects of ISSR will be analytical and hence need to be taken into account.
Programmers are needed to prepare integrated datasets. In today's clinical trials, large sets of complex data about drug responses, patient attributes, adverse events, trials size, drug dosage, post-market surveillance, and drug discovery among others are generated. Computer power enables compilation of ISSR with the help of programmers. Using a standard format of ISSR across various trials projects can help programmer be more efficient in compiling data.
Medical writers combine the analysis report of ISSR provided by the statisticians and the integrated data sets compiled by the programmers and produce the final clinical safety report that is to be submitted to the agencies/regulators.
A centralized team, including the above three specialists working in tandem to create an ISSR provides a greater probability for the regulators to approve the submission.