Clinical trials are highly controlled environments that allow researchers to monitor participants closely. This control gives scientists high-quality data about new drugs, but it also comes with limitations. Sometimes, for example, real-world circumstances can have an effect on a drug’s performance in ways that cannot be predicted by a clinical trial.
As a result, so-called real-world evidence (RWE) is gaining increasing importance in pharmaceutical research and development. However, RWE is not without controversy. If you’re considering clinical research training, here’s what you should know about RWE and its use in drug approvals.
Real-World Evidence Utilizes Data Beyond the Traditional Clinical Setting
Defining what counts as RWE is an ongoing process. The US Food & Drug Administration (FDA) defines real-world data, which is what leads to RWE, as data “derived from sources other than traditional clinical trials.” That, however, is a broad definition that could apply to many different situations. In practice, RWE refers to such things as electronic health records, insurance claims, questionnaires, medical apps, wearable devices, and much more.
RWE became an especially important topic in drug development after the US passed the 21st Century Cures Act in 2016, which instructed the FDA to evaluate the potential application of RWE in supporting drug approvals. Since then, RWE has been used in a handful of drug approvals. Health Canada is also currently working on RWE regulations and strategies which it plans to finish by the fall of 2022.
Students in the Clinical Research Program Should Consider RWE as Complementing Trials
Using RWE to support drug approvals is somewhat controversial. RWE has drawbacks compared to clinical evidence, including the fact that participants cannot be directly observed, the data quality may be unverifiable, and the study environment is uncontrolled. Some RWE evidence may also be prone to bias. For example, using data from wearable devices may overlook populations that cannot afford such devices.
Clinical trials, on the other hand, are highly controlled. In your diploma in clinical research you will learn about some of these aspects, such as writing study protocols and monitoring clinical trials. By being able to monitor and manage clinical trials, it is possible for researchers to closely follow patients, such as when and what they are eating, when they are sleeping, and how much physical exercise they are getting. This makes it easier to establish links between what effect the drug has on participants and what participants’ actions have on the drug’s performance. Likewise, because the protocols and data from trials are documented, results can be replicated and verified by other scientists, which is not always possible with RWE.
But RWE does have advantages when used as supplementary evidence alongside clinical trials. RWE could even provide new insights into data produced by the clinical trials that you might use after completing your clinical research program. For example, by tracking electronic health records researchers can gain insights into the long-term effects of a drug months or even years after clinical trials have ended. These long-term studies are not always possible in clinical trial settings, which are often limited to a few days or weeks in time. So, while RWE is far from perfect, by giving researchers and healthcare professionals more data, it can hopefully lead to better and more informed treatment and drug approval decisions.
Are you ready for a new career?
Contact AAPS College to learn more about our clinical research training in Toronto.