Post-market surveillance trial

Phase IV Post Marketing Surveillance Trial. Determines ongoing safety of the medication after the medication is being prescribed by healthcare providers. 

What is the purpose of the Post Marketing Surveillance trial ... 

Phase IV clinical trials are post-marketing approval trials to monitor the efficacy and side effects of the drug in an uncontrolled real-life situation. This is also known as a post-market surveillance trial. Information about the effectiveness of the drug compared with established treatment, side effects, patient7s quality of life, and cost-effectiveness is collated. 

A review of case reports, clinical trials, post-marketing surveillance, and drug monitoring studies concurrently showed that the most common side effects were gastrointestinal, dizziness/confusion, and sedation (Ernst et al. 1998). Importantly, the side effects of hypericum in this study were comparable to placebo levels. A pharmacokinetic study showed that plasma levels of up to 300 ng/ml were well tolerated. Headache occured in one subject who was taking 1200 mg extract (59 mg hyperforin, plasma cone. >400 ng/ml) (Biber et al. 1998). 

Phase III Extended large-scale trials to obtain additional evidence of efficacy and safety, and definition of adverse effects. Humans exposed several hundred to several thousand Phase IV Post-marketing surveillance occurs after the chnical trials programme is complete. It is used to collect adverse event data from a large patient population. Humans exposed 10 000+... 

These deliberations may result in several outcomes. Clinical development may continue as planned, but additional vigilance with more frequent visits and special tests may be added. The dose may be reduced or certain at-risk subjects may be excluded from further trials. The drug may proceed to registration, but the authorities may stipulate that a post-marketing surveillance study be conducted. The drug may even be withdrawn from further clinical development. 

The pharmaceutical industry presents many new challenges to such a person which include the interface with pharmacy and pharmacology, toxicological research, human volunteer studies, clinical trials and post-marketing surveillance to name just a few. Product safety is a factor which impacts on all of those endeavours and the pharmaceutical physician will be expected to work and provide advice within that framework. It will be clear to anyone that evidence of lack of safety in a medical product is not good news for the company concerned and that some level of protective action will often be required which in extreme circumstances may involve product withdrawal. It is, therefore, essential that the pharmaceutical physician should be absolutely clear what constitutes lack of safety in relation to the intended use of the product. 

In a post-marketing surveillance study in 27 803 patients with diabetes mellitus (94% type 2), data were reported after 12 weeks. The doses of acarbose were low 4.1% took less than 100 mg/day, 64% 100-250 mg/day, 32% 250-300 mg/day, and 0.1% more than 300 mg/day. Only 2.1% stopped therapy, mainly because of gastrointestinal adverse events. Tolerability appeared to be good and independent of age. Abnormal liver function was reported in 0.01%. The difference between these results and those of many controlled trials may in part be explained by the fact that higher doses have been used in most trials (14). 

In a post-marketing surveillance study there were some cases in which fluoxetine alone appeared to have precipitated hepatitis, which remitted when treatment was withdrawn (27). Fluoxetine can cause mild increases in liver enzymes, with a rate in clinical trials of about 0.5%. Rarely this can progress to hepatitis. 

Duloxetine has recently been marketed as an antidepressant in Europe. It inhibits the re-uptake of serotonin and noradrenaline, with minimal effects on other neurotransmitter mechanisms. It is therefore classified as a serotonin and noradrenaline re-uptake inhibitor (SNRI) and is grouped with venlafaxine. The adverse effect profile of duloxetine appears to be similar to that of the SSRIs and venlafaxine. In placebo-controlled trials the most common adverse effects were nausea (37%), dry mouth (32%), dizziness (22%), somnolence (20%), insomnia (20%), and diarrhea (14%). Sexual dysfunction has also been reported. Current data suggest that, unlike venlafaxine, duloxetine does not increase the blood pressure, but further post-marketing surveillance studies will be needed to confirm this (1). 

Does it work and is it safe in aii patients (Phase IV clinical trials or post-marketing surveillance)... 

They must concern regulatory approved products used in approved indications and can include, but not only, non-interventional trials, observational trials, post-marketing surveillance and post-authorisation safety studies. 

Post-marketing surveillance studies, pharmacoeconomic studies, non-interventional trials, clinical audit programmes and the like, which have been commissioned, undertaken or provided by companies, must never be promotional in nature and must be conducted primarily with a scientific or educational purpose. This clause does not preclude the use of the data generated from such studies to support claims in promotion. 

Demonstration of safety Premarket approval required Testing in animals Phase I/II/III clinical trials Post marketing surveillance system Manufacturer must meet OTC monograph standards 1 Premarketing approval or postmarketing surveillance not required Citation of existing literature... 

Is there any supporting evidence from clinical trials, post-marketing surveillance studies or animal studies ... 

Pharmaceutical manufacturing retail licenses are issued by BFAD. A local clinical trial must be carried out for new substances (new brands or new drugs), and registration is granted for one year initially. Post-marketing surveillance reports must be submitted twice a year to BFAD. Patent protection is available and implemented. 

While the evidence from trials with acceptable methodology was considered limited and more trials are called for, both reviews concluded treatment with P. sidoides offered relief from the symptoms of acute respiratory tract infechon, and specifically from acute bronchihs in children. Taking into account additional data from observational studies and post-market surveillance, results support the use of Umckaloabo (EPs 7630) as a possible alternative to antibiotics for the acute treatment of these conditions. Overall safety and a very low incidence of side effects have been confirmed. 

Clinical trials and post-marketing surveillance studies of rAHF have conclu-... 

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