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Saturday 20 January 2024

Signal Detection: Basics

Signal Detection Basics

Signal detection is the most extensive and critical topic in PV. While it is almost impossible to cover it one simple blog, we can try to introduce it at least.

 Definition of Signal: New potentially causal association, or a new aspect of a known association between an medicinal product and an event or set of related events which may require some action for ensuring patient safety. A signals may only be relevant for a particular medicinal product or a whole class of medicinal products.

 

1. Sources of Signal detection:

 

1. ICSRs 

2. Clinical trial data , Spontaneous data, Scientific literature

3. Experimental and/or non-clinical findings which has a significant impact on human exposure

4. Databases with larger datasets when the signal was detected from national or marketing authorization holder-specific databases (Eudravigilance)

5. Healthcare databases that may provide information on characteristics of exposed patients and medicines utilization patterns (VigiBase-WHO, FAERS)

6. Information from other regulatory authorities worldwide

2. Steps in Signal detection:

2. 1.  Detection: 

Using signal sources , first step is to detect signal by using any of the below     methods as per the disease, product portfolio and RA requirements.

2. 2.Validation:

 Once a signal is identified, validating it with different methodologies, and  assessing   if a true causal link is present between the event and drug.

2. 3.  Analysis and prioritization: 

Once we validate that a signal is indeed present, the next step is to analyze if the identified signal (event) is serious, severe, reversible, irreversible and its impact on public. A event that causes a irreversible damage or requires a very risky and expensive treatment obviously needs high prioritization. Based on this there is definition of signal, High, medium and low priority signals.

2.4. Assessment and recommendation for action: 

Once we prioritize a signal, we need to ensure there is action taken to minimize the impact of signal. E.g. if a signal is identified as drug induced liver injury, then we may have to inform HCPs via USPI/ trainings to monitor liver enzymes of patients


3. Signal detection methods:

3.1.    Quantitative: High volumes e.g. EVDAS, Vigibase then Computational and stastical, Data mining algorithms, Disprotionality and eRMR

3.2.    Qualitative: Low volumes e.g. Company safety database then ICSR from safety database, Aggregate safety data, Literature and AESI

3.3.    Semi quantitative: Both together then Qualitative for safety database with low volumes and Statistical methods for high volumes from HA database

 

        4.Examples of actions to be taken:

 

4. 1.    Urgent Dear Health Care Professionals Communication warning of potentially increased risk of adrenal crisis during the swap over period, with the risk theoretically being highest in youngest patients, and those with least adrenal reserve or other comorbidities.

4. 2.    An update to the reference safety information.

4. 3.    An update to the EU RMP

 

 Written by:

Dr.Shraddha Bhange.
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