Table 1.

Main criticisms of postmarketing surveillance studies and recommendations to address these¹

Main criticisms	Safety assessment of marketed medicines recommendations
Prospective identification of patients for inclusion in the study	Patients to be enrolled prospectively, but this must not influence the decision to prescribe, that is:
	Drug to be prescribed in usual manner
	Drugs must be prescribed solely for the normal clinical indication
	Patients must be true candidates for the medicine being evaluated
Lack of comparator group makes it difficult to assess causal relation between drug and event	Include appropriate comparator group(s) (with the same disease/indication, receiving the usual care)
Slow recruitment results in inadequate study populations and delay in identifying any hazards	Adherence to a clearly defined study plan so that recruitment is not drawn out, for example:
	Minimal selection criteria, so that study population is representative of the general population of users
	Exclusion criteria limited to contraindications specified in the data sheet/summary of product  characteristics
Results of postmarketing surveillance studies are seldom published	All suspected adverse reactions to be reported in the usual way
	Serious adverse reactions to be reported to the Medicines Control Agency within 15 days
	Provision of brief progress report to the Medicines Control Agency every 6 months
	Final report to Medicines Control Agency within 3-6 months of completing follow up
	Study results to be submitted for publication
	Other guidelines for good practice:
	Studies should not be conducted for promotional purposes
	Highest standards of professional conduct and confidentiality must be maintained