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Signal Detection

 

 

 

 

 

Signal detection specialists at Syncitium International Ltd will provide you with full Signal Detection Service for your product, and give you efficient support in elaborating your own Signal Detection Standard Operating Procedure

 

 

 

 

 

 

 

Statistician specialists at Syncitium International Ltd organize seminars and training cessions dealing with technical aspects in signal detection

 

 

Signal detection in pharmacovigilance

 

 

 

 

 

Adverse drug effects are manifold and heterogenous. Detection of early warning signs of adverse effects and new signals often differ from previous experiences. Signals have qualitative and quantitative aspects. Different categories of adverse effects need different methods for detection

 

 

 

 

 

Detecting type B effects

 

 

 

 

 

Current pharmacovigilance is predominantly based on spontaneous reporting and is mainly helpful in detecting type B effects (those effects that are often allergic or idiosyncratic reactions, characteristically occurring in only a minority of patients and usually unrelated to dosage and that are serious, unexpected and unpredictable)

 

 

 

 

 

Detecting type A effects

 

 

 

 

 

Unusual type A effects (those effects that are related to the pharmacological effects of the drug and are dosage-related)

 

 

 

 

 

Detecting  type C effects

 

 

 

 

 

Those effects related to an increased frequency of 'spontaneous' disease are difficult to study, and continue to pose a pharmacoepidemiological challenge

 

 

 

 

 

 

 

 

basic considerations

 

 

 

 

 

Seven basic considerations can be identified that determine the evidence contained in a signal:

 

 

 

 

 

1- quantitative strength of the association

2- consistency of the data

3- exposure response relationship

4- biological plausibility

5- experimental findings

6- possible analogies

7- and the nature and quality of the data

 

 

 

 

 

 

Examples of other sources of signals

 

 

 

1- prescription event monitoring

2- large automated data resources on morbidity and drug use (including record linkage)

3- case-control surveillance

4- and follow-up studies

 

 

 

 

 

 

Standard signal management procedure at pharmacovigilance centers, includes the following steps:

 

 

 

 

 

1- signal detection and definition

2- literature search

3- preliminary inventory of data

4- collection of additional information

5- consultation with the World Health Organization Centre for International Drug Monitoring and the relevant drug companies

6- aggregated data assessment

7- and a report in writing

 

 

 

 

 

 

A better understanding of the conditions and mechanisms involved in the detection of adverse drug effects may further improve strategies for pharmacovigilance

 

 

 

 

 

 

 

 

Technical aspects in signal detection: About Quantitative methods for signal detection in pharmacovigilance

 

 

 

 

 

The simplest method for detecting signals is crude inspection of lists of spontaneously reported drug-event combinations. However, quantitative and automated numerator-based methods such as Bayesian data mining can supplement or supplant these methods

 

 

 

 

 

However, published evaluations of these techniques are mainly limited to large regulatory databases, and performance characteristics may differ in smaller safety databases of drug developers. This is why drug safety professionals should understand the theoretical basis and limitations of these methods, and automated methods should not be automatically accepted

 

 

 

 

 

Here are some methods with the greatest utilization and evidentially support:

 

 

 

 

 

1- proportional reporting rations

2- the Bayesian Confidence Propagation Neural Network  (BCPNN)

3- and empirical Bayes screening

 

 

 

 

 

The strengths, limitations, pitfalls and outstanding unresolved issues for each method should be known and pharmacovigilance specialists should not be intimidated by the mathematics. Understanding the theoretical basis of these methods should enhance the effective assessment and possible implementation of these techniques by drug safety professionals

 

 

 

 

 

 

 

 

Statistician specialists at Syncitium International Ltd organize seminars and training cessions dealing with technical aspects in signal detection

 

 

 

 

 

If you wish to know more about our Signal Detection Service for Pharmacovigilance, please Click_Here