What are Real World Evidence & Post Marketing Observational Studies

What are Real World Evidence – Post Marketing Observational Studies (PMOS)

Whether you are planning Health Economics & Outcomes Research (HEOR), a post-marketing observation study, a safety surveillance system, a chart review, or augmenting a randomized controlled trial (RCT) with Real World Data (RWD), an effective CRO can align your data collection and analyses with your objectives and leverage their statistical expertise to mitigate the risks inherent with messy Real World Data.

What is Real World Evidence?

As the name suggests, Real World Evidence (RWE) refers to data collected from real world instead of the randomized controlled trials which were previously the norm in the field of clinical studies. This relatively new practice has proven to greatly enhance the quality and effectiveness of clinical studies. This is because real world evidence services study real patients and the outcome of their treatment. This data is collected and analyzed from electronic health records, medical claims, billing databases, etc.

Real World Evidence becomes even more vital in cases where the usual clinical trial procedures don’t cover the entire patient populace of the specific disease. In other words, patients from remote geographic locations or age groups respond differently to the treatment as there was no representative in the trial group with a similar background to the patient. Real World Evidence helps tackle this type of problem.

Additionally, Real World Evidence also studies the effects of drugs over a longer period of time than is possible through standard clinical trials. Health Insurance companies and pharmaceutical companies greatly reduce their own financial risk with the help of real world evidence as it helps them understand their patients better and provide a better quality of drugs and treatment according to an individual’s specific needs.

One critical factor in the collection and use of real world data is the quality of the data itself. This quality of the data can be evaluated by looking at three factors: conformance, completeness, and plausibility. Conformance refers to whether the values collected in the data adhere to the specified format and standards prevalent in the industry. Completeness is simply the comprehensiveness or totality of the data collected since incomplete data may miss out on crucial information. Plausibility simply refers to how believable the collected data is. This is determined by looking at the uniqueness of the data.

Finally, the real world data collected should contribute to the purpose of the study. In other words, the data collected should be answers to the specific problem it is meant to tackle and not be an answer to a different problem.

Today, Real World Evidence is a driving force in the field of healthcare and research. Current trends and requirements indicate that this dynamic type of research is only going to grow. As a result, legislators and policy makers around the world are getting more involved in its development and growth.

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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