Drug Safety – Secondary Data Analysis

Document Type

News Article


Assessment of drug safety is a critical component of the drug development process. Although clinical trials assess drug safety and provide vital information for rational drug use, the adverse drug reaction profile so generated is often incomplete given the potentially significant differences in the data obtained from limited number of patients in controlled clinical settings and that obtained in real-world clinical settings. Since a lot of the clinical information generated in the healthcare settings is recorded on paper or electronically, and a vast amount of data is also obtained by government bodies, and the data is available, to varying extent and limitations, for research purposes, evaluation of such data may provide vital information which may not be obtainable or difficult to collect in a prospectively conducted clinical study. Such secondary data analysis also ensures effective use of the collected data to further inform regarding the safety profile of a drug as well as generate hypotheses that may then be evaluated by conducting prospective studies.

I am currently working on projects involving disproportionality analysis of adverse drug events extracted from adverse event databases. I am also interested in using hospital-level data to identify medication use issues as well as exploring other forms of secondary data which can directly or indirectly inform regarding drug safety.

Further reading:

  1. https://www.nature.com/articles/s41598-021-98325-w
  2. Assessment of adverse events associated with remdesivir use for coronavirus disease 2019 using real-world data: Expert Opinion on Drug Safety: Vol 20, No 12 (tandfonline.com)
  3. Effect of domperidone, ondansetron, olanzapine-containing antiemetic regimen on QTC interval in patients with malignancy: a prospective, observational, single-group, assessor-blinded study | Scientific Reports (nature.com)
  4. Drug–drug interactions in patients undergoing chemoradiotherapy and the impact of an expert team intervention | SpringerLink

I look forward for collaborating with researchers across the globe with common interest. Interested collaborators may contact at ashwin.kamath@manipal.edu.

Publication Date

Spring 10-1-2022