One size does not fit all: a summary of signal detection methods

Review Article

  • Rajrajeshwari R. Patil Pharmacovigilance-Lorenzo Circle, Brampton, Ontario-L6R 3N4, Canada
  • Vivek Singh Pharmacovigilance- Bindra complex, Tulip Apartment, Andheri-East, Mumbai-400093, India.
Keywords: Pharmacovigilance, adverse events, spontaneous reporting, signal detection, qualitative signal detection methods, quantitative signal detection methods, data mining algorithms

Abstract

The selection of an appropriate signal detection method is pivotal in the identification process of safety signals in pharmacovigilance. Nevertheless, the early detection of safety signals is even more important to prevent the occurrence of another thalidomide tragedy in humans. Spontaneous reports, follow-up studies, scientific literature, preclinical & clinical studies, are valuable sources of adverse events; but on the other hand, these reported adverse events are extremely diverse, hence comprehending this can result in formulating the right signal detection and evaluation strategies. Broadly, signal detection methods fall into two categories: qualitative and quantitative, each having its significance; while the quantitative methods help to handle the voluminous data during signal detection, the qualitative one does its part to pick the rare signals. Hence, there is no single universal method that would be a perfect fit to identify safety signals from all data sources or for all types of adverse events. Further, the signal detection process involves a series of steps right from signal detection to its final assessment & submission, to regulatory authorities confirming a signal as a 'possible safety alert'. Finally, the completed task of finding a confirmed safety alert would be meaningless if it does not reach the end-users of the drug concerned. Therefore, effective communication to health care professionals, patients including clinical trial subjects, pharmaceutical companies, and other stakeholders is equally important.

Author Biographies

Rajrajeshwari R. Patil, Pharmacovigilance-Lorenzo Circle, Brampton, Ontario-L6R 3N4, Canada

Senior Drug Safety Physician

Vivek Singh, Pharmacovigilance- Bindra complex, Tulip Apartment, Andheri-East, Mumbai-400093, India.

Drug Safety Physician

References

Council for International Organizations of Medical Sciences. Practical Aspects of Signal Detection in Pharmacovigilance. Geneva: Council for International Organizations of Medical Sciences; 2010.

Egberts TC. Signal detection: historical background. Drug Safety. 2007;30(7):607-9.

EMA Guideline on good pharmacovigilance practices, EMA Module IX – Signal Management, 2017; 827661 (R1):1-25.

Meyboom RH, Egberts AC, Edwards IR, Hekster YA, de Koning FH, Gribnau FW. Principles of signal detection in pharmacovigilance. Drug Safety. 1997 Jun;16(6):355-65.

Published
2021-09-01
How to Cite
1.
Patil RR, Singh V. One size does not fit all: a summary of signal detection methods. jpadr [Internet]. 2021Sep.1 [cited 2021Oct.16];2(3):4-. Available from: https://jpadr.com/index.php/jpadr/article/view/37