Module 6

03/10/2024

Sources of adverse reaction reports

• Interventional clinical trials (FTIH to Phase V) • Spontaneous reporting • Anecdotal reports • Social and digital media • Scientific and medical literature • Regulatory authority • Solicited reporting • Patient support programmes and market research • Post-marketing surveillance studies (non-interventional) • Registries • PASS, PAES

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Hierarchy of pharmacovigilance data

Randomised Trials Open Label Trials

PASS/PAES

Pharmacoepi

Increasing volume of ICSRs

Increasing credibility of evidence

Literature

Spontaneous

Solicited (PSPs)

26 Portnoff JM & Lewis DJ. The enigma of PV of patient support programmes. Ther Innov & Regulatory Science 2017 DOI_10.1177_2168479017696264

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