Real-world data represents all the information that reflects the real-life situation of patients: in their care practice, their management, the impact of their disease and their treatment on their daily life… This is “real-life data”.
Nowadays, real-world data are a major consideration for healthcare professionals. They provide useful information to supplement clinical trial data, with the potential to fill knowledge gaps concerning the use of medicines in routine clinical practice. Focus on the PROMETCO study, the Group’s first ever international prospective observational study of real-world data in colorectal cancer.
How did the PROMETCO project come about?
Alice Vermeire, Clinical Projects and Data Generation Manager. She currently leads the PROMETCO study: “PROMETCO came about as a result of discussions with Dr Miriam Koopman, Professor at Utrecht University Medical Center (Netherlands). Our observation was that in metastatic colorectal cancer there was a lack of data on real-world survival, treatment sequences, and patient quality of life.”
What does the study involve?
AV: “Developed and supported by the Global Medical Affairs department of Servier, PROMETCO is the Group’s first ever international prospective observational study of real-world data in colorectal cancer. A group of experts helped prepare the protocol and a patient association helped with the patient questionnaires.
This project is particularly important to me because it provides responses to hitherto unanswered scientific questions. We now know that the data available are derived mainly from randomised trials. These are a type of clinical trial in which healthy volunteers or patients are selected at random to receive a certain treatment (product, dosage, method, or placebo). This enables to avoid selection bias which could otherwise lead to the formation of different groups according to social background, medical history, dietary habits, personal situation, etc.”
What benefits can patients expect? And Servier?
AV: “For the patients, access to real-world data will allow us to ensure the efficacy of our products by opting for personalized treatment, and to identify any needs that are not being met by a treatment. For the Group, real-world data are an opportunity to increase our knowledge of drug use, but also to better understand the clinical management of the disease and the optimal treatment configurations according to patient profiles.
At Servier, we have never been more aware of the importance of furthering our understanding of patient needs and with each day that goes by we are more deeply involved in what we do.”
What are its key milestones?
AV: “Recruitment began in March 2019. So far, 115 of the 1000 patients envisaged have been enrolled across 20 European countries. At the end of the study in January 2023, a report will be published. Throughout the study, we also plan to publish articles in a scientific journal on the results of the study, particularly in terms of overall survival and the quality of life questionnaires.”