WS1: Interdisciplinary Safety Evaluation
- ASAP: This sub-task force has developed a multidisciplinary approach to product level aggregate assessment of clinical trial safety data, which continues to evolve. The ASAP process fosters proactive safety planning to promote consistency of collection and analysis of safety data across studies, facilitate earlier signal detection, minimize important missing data and strengthen characterization of the product’s emerging safety profile. In addition, the task force has focused on how the ASAP process informs FDA IND reporting decisions and safety reports to worldwide health authorities. The ASAP framework of qualitative and quantitative assessments, including for product safety topics of interest, lays the foundation for the integrated summary of safety at the time of product filing.
- Interactive safety graphics (ISG): The DIA-ASA Interdisciplinary Safety Evaluation scientific working group is developing a series of novel open-source interactive safety graphic tools to enhance the ability of safety and clinical development professionals to identify and evaluate safety signals. The current suite of tools includes the Adverse Event Explorer, Adverse Event Timeline, Laboratory Outlier Explorer, Paneled Outlier Explorer, Histogram, Results Over Time, Shift Tables, Delta-Delta Graph and the Hepatic Explorer. New tools under development in 2022 include the AE Volcano Plot, Renal Explorer and various QT displays. We are excited to release safetyGraphics 1.0 recently, which features an interactive hepatoxicity explorer. Learn more.
Click to toggle interactive hepotoxicity explorer demo
- Benefit Risk Assessment Planning (BRAP): This taskforce was initiated in 2019 and is composed of physicians, statisticians and decision scientists. The purpose of this task force is to incorporate a global evaluation of benefit-risk considerations and to develop a benefit risk assessment planning (BRAP) process and template to be considered during product development and the lifecycle which could be used to support interactions with regulatory authorities. To inform development of the BRAP recommendations we have already researched the regulatory landscape, assessed industry perspective via a survey, and assessed expert opinion via targeted interviews of key opinion leaders in industry, academia and regulatory sectors. As we continue to develop our BRAP recommendations, we work to maintain alignment with ASAP and BRATS taskforces, align with other benefit-risk working groups, and engage with the greater scientific community to share and gather feedback.
- Benefit Risk Assessment Tool Suite (BRATS): This multidisciplinary team, consisting of physicians, statisticians, and other scientists is creating a suite of software tools to support structured benefit-risk assessment. The approach in the suite will align with the BRAP template. The initial suite will include interactive benefit-risk value trees, forest plots and effects tables. The plan is to expand the suite to include other capabilities/tools in further releases. The tool suite will be built in R-Shiny and be freely available as an open-source, non-proprietary application to stakeholders in support of medical treatment benefit risk assessment.