title: Pharmacovigilance in Clinical Trials: Current Practice and Challenges.
abstract: In view of the MENA increasing participation in multinational trials and the increasing number of national/regional trials, this article explores potential areas of pharmacovigilance, requiring reform and provides recommendations for building a robust safety reporting system. Regulatory silence on expedited reporting requirements creates confusion for local sites that are part of multinational trials. Not allowing waiver for serious adverse events that are protocol specified or are study endpoints, along with lack of emphasis on causality as reporting criteria, adds substantial burden of uninformative cases for regulatory review. Despite global focus on Development Safety Update Report, local regulators are not yet insistent on real-time update of a drug's cumulative safety profile. Issues like reporting requirements for generic trials, pregnancy reporting and lenient timeline for death/life-threatening events need attention. Finally, the need to formulate an all-encompassing local pharmacovigilance guideline, in sync with global practice cannot be overemphasized.
authors.affiliation: a ClinGroup Holding , Hazmieh-Beirut , Lebanon.
authors.forename: N
authors.initials: N
authors.lastname: Cheaib
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000458:organization & administration* / Q000592:standards; D000352:Africa, Northern; D015984:Causality; D002986:Clinical Trials as Topic / Q000458:organization & administration* / Q000592:standards; D016568:Drugs, Generic / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D038622:Internationality; D008877:Middle East; D060735:Pharmacovigilance; D013997:Time Factors
chemical_list: D016568:Drugs, Generic
keywords: Development safety update report; expedited reporting; pharmacovigilance; serious adverse event; suspected unexpected serious adverse reaction