What is the purpose of a Development Safety Update Report or DSUR?
The DSUR represents a comprehensive assessment of the safety profile for an investigational drug (alone or in combination with other drugs) across studies ongoing and/or completed during the reporting period based on the ICH E2F guidance and any local guidances/regulations (eg, EU Clinical Trials Regulation: Questions and Answers). Notably, to promote global harmonization, the FDA will accept the DSUR to meet IND application annual report requirements (see FDA proposed rule for IND application annual reporting).
The reporting period for each DSUR is based on the Developmental International Birth Date (DIBD), which is the Sponsor’s first authorization to conduct a clinical trial in any country. Because submission of the DSUR is required within 60 calendar days after the DIBD anniversary, it is imperative that teams take the time to plan ahead and use efficient authoring strategies to create a DSUR that provides crucial insights into the evaluation of patient risk and/or safety concerns by the Sponsor and/or regulatory agency, as applicable.
Cross-functional collaboration is essential to collating DSUR information
Cross-functional collaboration between the nonclinical and clinical teams involved in the development of the study drug(s) is essential. Effective teamwork across departments enables timely collection of relevant information, data collection, and document review.
At Precision, the lead Medical Writer coordinates efforts with the Sponsor team and Precision’s team as follows:
- Project Manager
- A key linchpin to meeting project needs by facilitating team communications, timelines, and other activities in collaboration with the Medical Writer. Read more.
- Data Management lead
- Plans database activities (eg, coding, data clean, serious adverse event reconciliation, etc.) to prepare the data extract for the reporting period. Read more.
- Safety lead
- Provides relevant safety information, including safety case listings, and important insight into any safety concerns or changes to the risk profile as well as reviewing the document to ensure all relevant safety findings have been appropriately reported. Read more.
- Biostatistician
- Provides the final outputs for DSUR authoring in line with the DSUR guidance. If possible, data for multiple studies are to be provided by study and integrated across studies for total numbers. Read more.
- Regulatory lead
- Responsible for ensuring that the DSUR is compliant, including meeting any applicable regional regulations, and submitting the DSUR to the appropriate regulatory agencies. They may also be asked to provide confirmation of relevant document submissions, including protocols and IBs, and/or provide summary of important regulatory requests. Read more.
DSUR planning strategies are crucial to DSUR execution
Efficient planning by all team members before the DIBD anniversary is critical to maximizing the 60-calendar day timeline. As the DIBD anniversary approaches, each team member can begin collating information specific to their functional area (e.g., a summary of nonclinical studies/findings for the reporting period, actions taken for safety reasons, protocol and/or IB updates, a list of regulatory requests, etc.)
When it comes to DSUR authoring itself, the Medical Writer can leverage lean authoring strategies to streamline DSUR content, focusing on essential safety information and minimizing repetition across the DSUR. Other considerations include:
- Standardized templates: Templates standardize DSUR format, ensuring consistency across reports and efficient content creation.
- Collaborative tools for real-time updates: Using collaborative software enables cross-functional teams to contribute input in real-time, reducing bottlenecks in the review process.
- Focused content review: Reviewing content based on each functional area’s expertise facilitates targeted and efficient review.
Building fit for purpose DSURs with cross-functional collaboration, lean authoring, and strategic review
Cross-functional collaboration, lean authoring, and strategic review provide a framework for creating efficient, high-quality DSURs that meet regulatory standards. By emphasizing concise content, clear structure, and team integration, DSUR authors can produce well organized documents that facilitate regulatory review, provide a snapshot of the evolving safety profile, and ultimately enhance patient safety. These practices streamline the process, meeting tight timelines and allowing the team to focus on advancing drug development.
Optimize your DSUR process with an expert team that streamlines all your reporting efforts.
