In theory, any observed effects of a drug isconceived to be a combination of its class effect and its drug-specific effectas the members of the class share commonalities of some unique features (i.e.structure, function or physiologic/biochemical target).
Hence it’s critical forthe project team to review additional safety data which lead to withdrawal ofmarketed class drug. Project team should weigh available clinicalevidence for the investigational drug and the class-level warning (includingwithdrawn market drug) and re-assess the risks and benefits of currentstudy. Accordingly a plan should beprepared to issue an advisory to the study patient population and plan mustconsider the potential unintended consequences from this advisory. In consideration of above assumptions, beloware the key assumptions and proposed actions separated over immediate, mediumand longer run to mitigate the current risk: Key Assumptions:· Indication: Painmanagement of osteoarthritis patients· # Countries: 25 (Global)-all sites across countries currently activated · # Patient to beEnrolled in study: 25000 · # Patient Enrolled asof date: 6000 · # Patient CompletedStudy: 4000 · Treatment period: 1year · Other key protocolconsiderations: ECG measurements, laboratory tests and electronic patientdiaries for collecting pain score as well as other protocol require patientreported outcome (i.e.
sleep, rescue medication measures)· Additional safety riskto study investigational product due to withdrawal of marked class drug due tosafety issues. · Top priority: toprotect patient’s rights, safety and wellbeing, to keep the study patientsinformed of additional safety risk to the investigational drug due to classdrug effect. · Study recruitmentschedule and other key milestones (DBL etc.) to be unaffected.· The study utilizing a100% Source Data Verification (SDV) approach. Additional steps may be require(i.e.
100% monitoring of safety data) if the studies utilize a partial SDVapproach. · The study utilizing aData Safety Monitoring Board (DSMB)