Toxicologists x Real World Evidence = ?? (from the perspective of pharmacovigilance)

<p>It is needless to say that the findings from nonclinical toxicity studies are important to ensure the safety of subjects in the drug development. To compile new drug application dossier, the safety of developed compounds is comprehensively evaluated from both nonclinical and clinical data, and then the product is marketed after approval by the regulatory authorities. This is a scheme called “translational research,” the purpose of which is to deliver a new drug to the patients. In this process, there are many situations where nonclinical toxicologists work with the common goal of the approval of the drug. </p><p>In the last few years, Real World Data (RWD) has been treated as a common language in the pharmaceutical industries in Japan. Although RWD per se is very valuable, it is necessary to create Real World Evidence (RWE) derived from analyses with RWD in order to contribute to patients and public health.</p><p>The pharmaceutical industries are constructing evidence that contributes to decision-making by utilizing RWD/RWE in many situations from clinical development to post-marketing stage. As a feedback mechanism of these RWE to nonclinical or early clinical stages to lead to the development of new drugs, “reverse translational research” is advocated. Similarly, it is highly expected that the RWE on patient safety obtained in post-marketing will be provided to the nonclinical toxicologists and improve the quality of the safety evaluation from the aspects of science.</p><p>In this session, I would like to speak the collaboration between toxicologists and RWE, including future expectations.</p>