What are Post Marketing Observational Studies (PMOS)
If you are planning a post-marketing observation study an effective CRO can align your data collection and analyses with your objectives and leverage their statistical expertise to mitigate the risks.
What are Post Marketing Observational Studies?
Before a new drug or medical device is marketed to the public, it undergoes a series of clinical trials to test its safety and side effects. However, these trials are conducted on a small group of individuals which means that customers who use the marketed product may possibly react to it differently than anyone in the trial. This is where Post Marketing Observational Studies or Post Marketing Surveillance (PMS) comes in. PMS is the exercise of monitoring the safety and optimal use of marketed drugs and medical devices.
However, it must be noted that the use of Post Marketing Observational Studies is not only limited to monitoring the safety of a product. It goes beyond that to collect clinical data which is used for various purposes. This is because, unlike clinical trials, the data collected is not from a small selected group but a much larger group with a more diverse spectrum. In other words, Post Marketing Observational Studies evaluates the difference between the efficacy and effectiveness of a product. The efficacy of a drug is judged in a controlled environment with strict inclusion and exclusion criteria which is present in a clinical trial. Effectiveness, on the other hand, is the real world evaluation of a drug after it has been released for sale to the general public where there is no close monitoring or compliance involved.
A crucial characteristic of Post Marketing Observational Studies which must be mentioned is that it is a non-interventional study. This means that unlike clinical trials where conductors of the trial may intervene at any time depending on the results they see, this is not possible with the collection of data post marketing. Thus it provides a more important picture of the performance of the drug with the general public.
In most countries around the world, conducting such studies is mandatory and usually enforced by the governing body of drug and medical regulations. The result of such studies is that pharmaceutical companies can give better information about the product to the public based on the experiences of previous customers.
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