When assessing a safety signal, Lilly's physicians and scientists review individual adverse event case reports to assess the relative strength of available evidence that a drug treatment may have contributed to the development of an event.
How is a Causal Link Evaluated?
Safety signals are assessed and evaluated, using all relevant sources of safety data, based on clinical and medical factors such as the potential public health impact and the strength of the signal. While spontaneous adverse event reports are very important for generating hypotheses and signals, there are limitations to such voluntary reporting. Lilly may also solicit the opinion of outside expert consultants or advisory boards to help assess the evidence of possible causality.
- Subjective and imprecise recognition of the clinical entity or the relationship with exposure to a medicinal product.
- Reporting biases, such as the length of time a product has been on the market, country where the report originates, reporting environment (eg. media attention)
- Lack of denominator data, precluding the computation of incidence rate
Because of these limitations, Lilly assesses a possible causal association based on a comprehensive evaluation from all available data sources rather than spontaneous adverse events alone.
Based on the strength of evidence, a risk may be considered "potential" or "identified (established)."
An adverse event for which there is some basis for suspicion of a causal association with the medication of interest but where this association has not been confirmed is considered a potential risk.
Within the context of Lilly's signal management process, a potential risk represents a safety signal that requires additional evaluation. This may include more extensive follow-up on individual cases or more intensive monitoring activities. Lilly also may further evaluate the potential risks by means of additional studies (for example clinical trials or observational studies).
Identified (Established) Risk
An adverse event for which there is adequate evidence of a causal association with the medication is an identified or established risk.
All identified risks are included in the Company's Core Safety Information (CSI) Core Safety Information (CSI).