The importance of real-world studies
Real-world studies reflect current practices with respect to how patients react to treatment in terms of tolerance and efficacy. Such observational studies enhance medical knowledge, as well as patient and doctor experiences by helping to develop better treatments that ultimately benefit patients.
Real-world data are collected from a variety of sources and relate to the lived reality of patients and doctors, drawing on information such as the delivery of health care, treatments, as well as the impact of the disease and its treatment on patients’ lives. In other words, these data reflect the real lives of people affected by the illness in question and complement those derived from traditional clinical trials. Such additional robust analysis on the experience people have of living with diseases and medical treatment helps to expand therapeutic understanding.
A structured methodology
It is important to first understand the needs of all stakeholders in order to precisely identify the matters that require research, whether in relation to medical concerns, medical economics, or even regulation. Although it takes time to identify sources of data and deploy a suitable methodology, such steps are essential to obtain robust findings. Data are then analyzed using increasingly high-performance digital platforms that enable the Group to compile ever larger data bases so as to exploit ever more homogeneous and standardized data.
Servier’s increased use of real-world studies
Real-world studies offer valuable insight. The first real-world data study conducted by Servier in oncology, PROMETCO, is looking into metastatic colorectal cancer. The protocol for this prospective study was developed with a group of experts and a patient organization. The study will collate data regarding the clinical treatment of colorectal cancer with a view to improving practices in the future. Furthermore, Servier studied the effect of a treatment for type 2 diabetes in real-world conditions on patients who fast during the month of Ramadan.
In addition, the Group conducted its first-ever large-scale study into diabetes using a register in Asia covering data from 11 countries, the findings of which will enrich understanding of patients living with this condition in the region.
Servier also works on studies in cardiometabolism in order to assess patient adherence to their treatment. Examples such as these demonstrate the impact real-world studies can have on decisions made by key members of the health care community.
“At Servier, we are committed to involve patients in our actions to improve our understanding of their needs. The deployment of real-world study programs allows us to increase our knowledge of medicine use for the benefit of patients. This is the case of PROMETCO, the first real-world data study in oncology conducted by Servier. The ambition is to find out more about the reality of managing metastatic colorectal cancer from the point of view of the patient and the physician.” Valérie Lehner-Martin, Medical Excellence and Real World Director, Global Medical and Patient Affairs.
Focus on PROMETCO
Launched in 2018 and developed in collaboration with the Digestive Cancers Europe (DiCE) patient association, the PROMETCO real-world study will enable Servier to better take into account the reality of metastatic colorectal cancer management from the patient’s and doctor’s perspective. The results of the PROMETCO study, expected in 2023, will contribute to gaining a better understanding of howthese patients are treated under usual conditions. In this way, the resultscould help improve future practices, particularly regardingtreatment performance and personalization.
1,000 patients: enrollment goal
125 research sites involved
18 countries involved