Real World Data vs Clinical Trials?
Because it is a trending topic, it doesnt means it has to replace everything. Using Real World Data to generate Real World Evidence has to be used wisely, sometimes it complements product development, but historically it has been used to provide active pharmacovigilance in a "phase IV" trial. Around the last 2 decades, Real World Data cohorts and/or different combinations with clinical trials were used more frequently enhancing the reliability about large application of a drug or therapy out of the "highly controlled clinical trials scenarios". Real World Data use has been largely extended and has many applications, however, more important than analyzing Real World Data with Artifical Intelligence or Machine Learning is to assure what steps and methodologies were applied to generate the Real World Data; do we have plenty access to medical records? how the information from patients was obtained and recorded? do we have Electronic Health Record? are those records are in a HL7 system? What are the procedures and quality assurance systems to record and review the data?. All these questions are very important and are a main difference from how the data is collected in a clinical trial.