In theory, any observed effects of a drug is
conceived to be a combination of its class effect and its drug-specific effect
as the members of the class share commonalities of some unique features (i.e.
structure, function or physiologic/biochemical target). Hence it’s critical for
the project team to review additional safety data which lead to withdrawal of
marketed class drug. 

Project team should weigh available clinical
evidence for the investigational drug and the class-level warning (including
withdrawn market drug) and re-assess the risks and benefits of current
study.  Accordingly a plan should be
prepared to issue an advisory to the study patient population and plan must
consider the potential unintended consequences from this advisory.  In consideration of above assumptions, below
are the key assumptions and proposed actions separated over immediate, medium
and longer run to mitigate the current risk: 

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Key Assumptions:

Indication: Pain
management of osteoarthritis patients

# Countries: 25 (Global)-
all sites across countries currently activated

# Patient to be
Enrolled in study:  25000

# Patient Enrolled as
of date: 6000 

# Patient Completed
Study: 4000

Treatment period: 1

Other key protocol
considerations: ECG measurements, laboratory tests and electronic patient
diaries for collecting pain score as well as other protocol require patient
reported outcome (i.e. sleep, rescue medication measures)

Additional safety risk
to study investigational product due to withdrawal of marked class drug due to
safety issues.

Top priority: to
protect patient’s rights, safety and wellbeing, to keep the study patients
informed of additional safety risk to the investigational drug due to class
drug effect.

Study recruitment
schedule and other key milestones (DBL etc.) to be unaffected.

The study utilizing a
100% Source Data Verification (SDV) approach. Additional steps may be require
(i.e. 100% monitoring of safety data) if the studies utilize a partial SDV

The study utilizing a
Data Safety Monitoring Board (DSMB) 

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