Exploratory Data Analysis And Safety Assessment In Preclinical And Clinical Studies

Exploratory data analysis is performed at different levels In the Novartis research and development environment, beginning at the individual study level. During a clinical study, monitoring safety biomarker trends and incidences of adverse events over time can be crucial to detect relevant safety signals as early as possible and decide on potential risk management and risk minimization steps.

After completion of a study, the cross-functional project team may benefit from jointly and interactively querying safety data to further explore any signals and start to generate mechanistic hypotheses suited to explain any relevant safety observation.

At the same time, the team can select the most suitable graphical displays of safety information to be included in final study reports or submission documents.

Across an entire project, systematic data exploration may help to further assess the relevance of putative signals, identify dose-response relationships, if any, and screen for risk factors in the target population.

Finally, at a broader level comparing effects across different indications, exploratory graphical data analysis can support teasing out disease and population specific differences in safety profiles of a drug candidate.