PV signal and signal detection & what is the signal detection discus in this slide show. Kiran Rajput MSc in clinical Research 3rd Semester 2021

1. SIGNAL & METHOD OF
SIGNAL DETECTION
CMCR: 606
PHARMACOVIGILANCE
PRESENTED TO PRESENTED BY
Dr. SAURABH KOHLI Kiran Rajput
Assistant Professor M.Sc. C.R.
Department of Pharmacology Sem 3

2. SIGNAL
• According to WHO signal is “Reported information on a possible casual relationship
between an adverse event and a drug, the relationship being unknown or
incompletely documented previously”.

3. • A safety signal is information on a new or known adverse event that may be caused
by a medicine and requires further investigation.
• Signals can be detected from a wide range of sources, such as spontaneous reports,
clinical studies and scientific literature.
CONT…

4. SIGNAL DETECTION
• Pharmacovigilance involves the collection of data on adverse reaction which must
then be analysed and evaluated to create meaningful safety information.
• Signal detection in pharmacovigilance involves looking at the adverse reaction data
for patterns that suggest new safety information.

5. AIMS OF SIGNAL DETECTION
• Signal detection aims to identify and describe suspected harm to patients, caused by
their use of medicine.
• The evidence comes primarily in the form of spontaneous reports from health
professionals across the world, from pharmaceutical companies and some from
patients.
• Signal detection is a core UMC ( Uppsala Monitoring Centre) activity.

6. METHOD OF SIGNAL DETECTION
• Commonly signal detection done in two methods are-
1. TRADITIONAL PHARMACOVIGILANCE METHODS
2. DATA MINING ALGORITHMS

7. TRADITIONAL PHARMACOVIGILANCE
METHODS
• Individual case review
• Aggregate analysis
• Periodic analysis
• Traditionally, signals are detected through the assessment of individual case
safety reports in an individual or cumulative manner.

8. 1. Qualitative review of ICSR
• Critical method of detection for events where the background incidence is
uncommon or rare and should not be replaced by quantitative methods

9. 2. Qualitative review of ICSR
• Periodic review of the aggregate tables displayed in these periodic reports can
provide indication of potential striking events.
• Periodic review of case series.

10. Quantitative assessment of ICSR
• No of reports of an adverse event or adverse product reaction.
• Absolute counts

11. Quantitative assessment of ICSR
• No of specific AE reports divided by total no of reports for a given product.
• Proportion

12. DATA MINING ALGORITHMS
• Once the ICSR database become large enough, statistical techniques can be applied.
• Generally these techniques identify disproportionate reporting ratios.