What is Real-World Data (RWD)?

As defined by Food and Drug Administration (FDA) (1), “Real-world data (RWD) are the data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources. RWD can come from a number of sources.”

What is Real-World Evidence (RWE)?

As defined by the FDA (1), “Real-world evidence (RWE) is the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of Real-World Data (RWD). RWE can be generated by different study designs or analyses, including but not limited to, randomized trials, including large simple trials, pragmatic trials, and observational studies (prospective and/or retrospective)”


For a better understanding, the following videos are available:

  • The youtube channel RARE-X has developed a video  called “RARE-X Definition Series: Real World Data and Real World Evidence” that it is ideal to someone who wants to understand the concepts Real World Data and Real World Evidence. Watch it now.

What data is collected?

Nowadays, RWD can be acquired in different forms by numerous means, such as Electronic Health Records (EHRs), Electronic Medical Records  (EMRs), product and disease registries, lab/biomarkers, citizens-generated data (which includes those of home use devices), existing observational studies, genomics, mortality, data gathered from other sources that can inform on health status, such as applications on mobile devices, social media and so on.

How is this data analysed to evidence?

Organizations such as the FDA have standard procedures following the data collection focusing on their storage (2). Whether computer or paper based, the data is abstracted, assembled, and stored in specific databases (i.e., registries), or collected and aggregated through other means. RWD cannot be used immediately after being acquired as it might be unsuitable to assist in regulatory decision-making; thus, this data must first be converted into evidence through a data assessment activity. An important notion about RWD collected from different sources is that most of it was developed for different purposes like insurance claims or drug billing activities. It is because of this that these types of data should come as complete as possible to be applicable to the subject at hand and converted into evidence. The FDA evaluates every data source with the same parameters (2). The data assessment focuses on different aspects of quality such as relevance, source reliability, and content. This procedure will inform on the ability to generate evidence that may be used as an asset in regulatory decision-making. Furthermore, during the qualification process the data quality must reflect its necessity in regulatory decision-making which means that if the data is going to be essential, the same applied standard will rise to match the high-quality data obtained. If RWE is applied from distinct sources, every single source is qualified individually because it might affect the overall decision process (2).

The usage of RWD/E to augment the effectiveness of clinical trials must fit a framework established by their regulatory agencies; for the FDA, this should be taken into consideration while evaluating the following RWD (3).

  • “Whether the RWD are fit for use
  • Whether the trial or study design used to generate RWE can provide adequate scientific evidence to answer or help answer the regulatory question
  • Whether the study conduct meets FDA regulatory requirements (e.g., for study monitoring and data collection)”

For a better understanding, the following video is available:

  • The youtube channel AJMCtv from the American Journal of Managed Care has developed a video called “Dr ian F. Hernandez on the Future of Real-World Evidence” which are outline the advantages of the using of devices to collect data. Watch it below.


  1. https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence Acessed March 2021
  2. https://www.fda.gov/media/99447/download Accessed March 2021
  3. https://www.fda.gov/media/120060/download Accessed March 2021
  4. Burcu M, Dreyer NA, Franklin JM, et al. Real-world evidence to support regulatory decision-making for medicines: Considerations for external control arms. Pharmacoepidemiol Drug Saf. 2020;29(10):1228-1235. doi:10.1002/pds.4975
  5. https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence Accessed March 2021

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Alexandre Gil and Pedro Granjo from Sci and Volunteer Program Nova School of Science and Technology 2021.


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Page modified at Thursday, October 20, 2022 - 07:02