Pre &; post marketting survellance

1. By: Tehseen Riaz
Bsc, Pharm-D, R.PH, MPhil

2.  Pre-marketing are studies
conducted to evaluate first, the
safety and second, the efficacy of
the new compound in humans.

3.  Post-marketing monitoring includes the
identification and monitoring of new
additional adverse drug events from doctors
or other health professionals. Unlike previous
stages, these will be observational studies
where the long-term effectiveness will be
evaluated; these are conducted right after the
commercialization of the drug to the “real
world”.

4. Pre-marketing clinical trials Post-marketing monitoring
Small number of patients: 100- <10000 Big number of patients: >10000
Age and gender limitation No age and gender limitation
Patients selected with precise diagnosis Patients not selected; more random
Well defined and short duration: 1-3 years Undefined and longer duration
Careful and constant follow-up Casual and less constant follow-up
Highly detailed reports Much less detailed reports
Use specific terminology Use less specific terminology
Other concomitant treatments are excluded (usually) Possible concomitant treatments
Used of surrogates markers instead of the outcome of interest (e.g. blood
pressure or lipid levels to establish potentially fatal outcome such as heart
attack)
Used the outcome of interest
In clinical research setting Starts after marketing

5. Benefits of the pre-marketing
clinical trials
Controlled environment
Strict inclusion/exclusion criteria
Known denominator for patients
exposure (so we could establish the
incidence of adverse events)
Data collected on standardized form
Follow-up information is generally
accessible
All reports are medically confirmed
The data collected in clinical trials is
clean and reproducible

6. Benefits of Post-Marketing
Monitoring
Low frequency reactions (not
identified in clinical trials)
High risk groups
Long-term effects
Drug-drug/food interactions
Increased severity and / or
reporting frequency of known
reactions