Post-marketing studies

Post-marketing studies of cohorts of patients, often assembled by practitioners with the support of the relevant pharmaceutical company, may also be useful in detecting ADRs related to new drugs but they have been criticised for their small size and that they are interventional. These criticisms are supported by the history of some of these studies, but they cannot be seen as intrinsic reasons why the approach is not valid if the studies are carried out properly and to completion. 

Hasford, J. and Lamprecht, T., Company observational post-marketing studies drug risk assessment and drug research in special populations — a study-based analysis, Eur. J. Clin. Pharmacol, 53, 369, 1998. 

Yoshioka, A., Fukutake, K., Takamatsu, J., and Shirahata, A. (2006). Clinical evaluation of recombinant factor VIII preparation (Kogenate) in previously treated patients with hemophiliaA descriptive meta-analysis of post-marketing study dateit. J. Hematol., 84, 158-165. 

This is a post-marketing study, to establish the long-term safety of a drug, especially when a biopharmaceutical is intended for prolonged use. If unexpected adverse effects are observed the product can be withdrawn from the market. Some Phase III licenses are granted with the condition that an additional study phase should follow according to a predefined plan. 

Post-marketing studies, also called phase IV studies, often have several objectives ... 

Mackay FJ, Wilton LV, Pearce GL, Freemantle SN, Mann RD. The safety of risperidone a post-marketing study on 7684 patients. Hum Psychopharmacol... 

Sadek AH, Fix A, French J. Levetiracetam related adverse events a post-marketing study. Epilepsia 2002 43 Suppl 8 151. 

The procedure for the review an approval of post-marketing studies is the same as for international multicenter studies. 

Post-marketing studies should not be carried out and used in order to influence physicians, and should not be disguised as research. 

Phase IV Drug Development Post-Marketing Studies... 

CH10 PHASE IV DRUG DEVELOPMENT POST-MARKETING STUDIES... 

In practice, good NDA sponsors find that post-marketing studies lead to package insert changes much more often than withdrawal of the entire NDA. There is also no evidence, so far, that the accelerated approval process has led to any serious threat to the public health. This new reviewing practice that appears to be working well. 

Finally, Johnson Johnson state that they now use stoppers that are coated to prevent such reactions, adding that they believe this incident to demonstrate the potential dangers of importing drugs into certain markets. Other researchers have agreed that there should perhaps be greater surveillance of the side effects after drags have been launched into the market place, and/or post-market studies conducted [11]. 

GCP compliance in post marketing studies Financial disclosure... 

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