Promotional literature

[Guest guest]

Respected members,

The most important information to be sought from the

promotional material includes the following points:

The disease: The drug should be indicated for the conditionsfor which it is

promoted as described by the existing guidelines. The disease under consideration should also be commonly

encountered in the respective clinician’s practice.

The need: Does the need for the promoted drug really exist?

The physician should consider the problems with the existing

recommended therapy and whether the new drug can overcome

the problems.

The patient: The patients in whom the drug was tested should

resemble the general population. If the patient profile in whom

the new drug was tested is substantially different e.g. in age,

disease type and severity, then the results cannot be

extrapolated to

the general population.

The comparator: Careful attention should be paid to the

drug with which the new drug is compared. The dose of the

comparator should also be same as the dose at which it is

prescribed. Using a lower dose of the comparator would produce

results in favor of the newer drug.

The outcome of interest on the

promotional material :

The

outcome of interest on the promotional material can be classified as

disease-oriented or patient-oriented.[10] The disease-oriented outcomes show

the results in terms of biological parameters,

e.g. BP. This change may not translate into an actual

benefit to the patient. This outcome may be interesting, but changing the practice solely on its basis is not

appropriate and can be dangerous. The

patient-oriented outcome is the one which

evaluates actual benefits to the patient in terms of mortality, better quality of life and decreased cost.

No. Of subjects and Statistics:

Conducting a study with few patients can jeopardize

the results of the study. Hence the study should

have enrolled an adequate number of patients to detect a statistically significant difference.

Regards

Dr Sanjay Yallappa Choudhari

JR2,Dept of Pharmacology

GMC, Nagpur