Randomized clinical trials (RCT) have been the reference of excellence in evidence-based medicine to collect information about the safety profile and efficacy of a drug that has not yet been released on the market. These RCTs are carried out in meticulous compliance with international and local regulations to obtain quality data, safeguarding
the beneficence and confidentiality of the subjects who participated in these studies.
However, the RCTs are distinguished as studies whose eligibility criteria are highly restrictive and therefore far from representing more real populations with the pathology studied (in terms of comorbidities, ethnic diversity, etc.). This fact led to the need to generate data within a scenario closer to the routine of clinical practice and away from the strict control of the RCTs.
These information collection initiatives within routine clinical practice have been generating the concept of real-world evidence (or RWE in English). RWE offers effectiveness data and additionally, the safety data collected in this
context are related to more “real” patients, who are often polymedicated and have other comorbidities. In this scenario, adverse events that were not reported in RCT can be observed. Therefore, RWE brings experience of a new
treatment, in a more real world.
RWE data can be obtained from various sources that do not involve intervention. These sources include data from routine visits to the healthcare center, patient records, electronic devices such as diaries or technology platforms, prescription data, observational studies, and other primary and secondary patient data. This new perspective
has been consolidated before the regulatory agencies. The current view of the authorities is to evaluate the data collected in the real world (RWE) as a complement to the results provided by the RCT, not as its substitute.
Within this new world context, it is our intention to contribute with our experience to professionalization in the implementation, collection, verification and publication of study data throughout the entire spectrum of the development of a drug or device under evaluation. The process that we want to cover includes from the moment it is conceived, evaluated and approved for marketing (RCT) to the collection of evidence once the product/device is used within real-word care (RWE). We hope that our contribution deepens the knowledge that is collected from these innovative elements and promotes their more rational use, with the health of our patients as the main objective.
How would be the approach for RWE in COVID? COVID studies were covered too fast and the criteria to participate in the studies couldn´t been so strict and currently the planned studies had to modify their criteria because to include naive subjects is almost impossible since high proportion of population is already immunized or had presented the disease. Should the approached be evaluated as RWE?
Thanks for your comment Sofia. The COVID studies were planned and executed as the pandemia continued. I still believe that this type of studies is still performed under the strict observation of the GCP/ICH and local regulations (even though some INCL/EXCL criteria have to be less stringent).
However, we will witness a number of data collection approaches (observational studies – without intervention- evaluation of the clinical charts, Quality of life surveys) that will allow us to evaluate the COVID patients’ treatment in retrospect. This approach is closer to the RWD techniques than the COVID studies that you just mentioned.
Again, the RWD approach has been gaining importance in the planning and design of the randomized studies. So, my guess is that RWD/RCT will be co-existing in time as the drug/device gets ready for the market.
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