Principles of Signal Detection. Pia Caduff-Janosa MD Annual Course May 2013
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1 Principles of Signal Detection Pia Caduff-Janosa MD Annual Course May 2013
2 Outline What is a signal? Signal sources Triggers Assessment of potential risk Signal evaluation Outcome 2 Pia Caduff-Janosa, Uppsala Monitoring Centre
3 What is a signal? Reported information on a possible causal relationship between an adverse event and a drug, the relationship being unknown or incompletely documented previously. Usually more than a single report is required to generate a signal, depending upon the seriousness of the event and the quality of the information. The publication of a signal usually implies the need for some kind of review or action. 3 Pia Caduff-Janosa, Uppsala Monitoring Centre
4 Signal sources Individual Case Safety Reports Clinical studies Literature WHO Programme-UMC Scientific conferences Drug Regulatory Authorities Media 4 Pia Caduff-Janosa, Uppsala Monitoring Centre
5 5 Pia Caduff-Janosa, Uppsala Monitoring Centre
6 Signal bells when should they start ringing? 6 Pia Caduff-Janosa, Uppsala Monitoring Centre
7 Triggers ADR reported is unexpected Fatal outcome or life threatening course Specific ADRs SJS, TEN Agranulocytosis Cluster Unusual aspects of expected ADRs 7 Pia Caduff-Janosa, Uppsala Monitoring Centre
8 Action Signal confirmed? Case series further information Individual case safety report 10 Pia Caduff-Janosa, Uppsala Monitoring Centre 10
9 How many reports make a signal? 3 index cases Completely documented No or only minimal confounders Positive de-/rechallenge 11 Pia Caduff-Janosa, Uppsala Monitoring Centre 11
10 Further information? What do we know about the drug itself? What do we know about the way it is used? What do we know about similar drugs (class effects)? Is there a reasonable causal relationship between drug and reaction in our case reports? Signal assessment = causality assessment?? 12 Pia Caduff-Janosa, Uppsala Monitoring Centre
11 Signal assessment Labelling national and international Case series in databases? National database VigiBase/VigiLyze Literature 13 Pia Caduff-Janosa, Uppsala Monitoring Centre 13
12 Signal assessment Small database Mostly case series and assessment of ICSRs Large database Automated search for disproportionalities Case series 14 Pia Caduff-Janosa, Uppsala Monitoring Centre
13 UMC signalling process WHO db VigiBase National PV Centres Pharma Company Data mining Disproportionality measure (IC) Triage algorithms UMC review Literature check etc 15 Pia Caduff-Janosa, Uppsala Monitoring Centre Not (yet) signal Clinical assessment UMC + Review Panel
14 Data analysis single case Demographic data Medical history Chronology Risk factors Differential diagnosis De-/Rechallenge Concomitant medication Other confounders/bias 16 Pia Caduff-Janosa, Uppsala Monitoring Centre 16
15 Signal assessment is about patterns Who is at risk? Are there patient specific risk factors? Are there drug specific risk factors? Is there a geographical pattern? Does the ADR follow a pattern? 17 Pia Caduff-Janosa, Uppsala Monitoring Centre
16 Signal assessment There is no magic button Pia Caduff-Janosa, Uppsala Monitoring Centre
17 Signal assessment is about... Hard and patient intellectual work 19 Pia Caduff-Janosa, Uppsala Monitoring Centre
18 ...and Decision making 20 Pia Caduff-Janosa, Uppsala Monitoring Centre
19 Dilemma A signal should be identified as soon as possible to allow early warning but should be documented as well as possible (credibility) When is there ENOUGH evidence? 21 Pia Caduff-Janosa, Uppsala Monitoring Centre 21
20 Risk minimization Action taken (mostly) by Regulatory Authorities with the aim of keeping a positive benefit risk balance 22 Pia Caduff-Janosa, Uppsala Monitoring Centre
21 Potential risk Exposed population (size, sensitive populations) Essential medicinal product Seriousness and severity of ADR Avoidable ADR? Rapid increase of number of reports Public impact and perception 23 Pia Caduff-Janosa, Uppsala Monitoring Centre
22 The risk potential defines the next move 24 Pia Caduff-Janosa, Uppsala Monitoring Centre
23 If the risk is assessed as very high, risk minimizing actions might be justified even if the signal is not (yet) confirmed 25 Pia Caduff-Janosa, Uppsala Monitoring Centre
24 More on this......on Monday May 8.30 am 26 Pia Caduff-Janosa, Uppsala Monitoring Centre
25 Take home messages A signal is a work hypothesis that needs to be confirmed or refuted Signal assessment is a dynamic process Signal detection is a lifelong process for every medicinal product Well documented ICSRs (index cases) are one of the most precious elements in signal detection and assessment Signal assessment is intellectual work 27 Pia Caduff-Janosa, Uppsala Monitoring Centre 27
26 28 Pia Caduff-Janosa, Uppsala Monitoring Centre Questions?
27 Uppsala Monitoring Centre Box 1051 SE Uppsala, Sweden Visiting address: Bredgränd 7, Uppsala tel fax website 29 Pia Caduff-Janosa, Uppsala Monitoring Centre
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