Pharmacovigilance, phase 4 clinical trials, pharmacoepidemiology, have for many years been part of the post-market monitoring of medicines and medical devices. These studies are set up to ensure the cost-benefit balance of treatments in real situations and their clinical efficacy. Now, the adoption of digital technologies is transforming the face of decision-making in care. Mobile applications, connected devices, and activity sensors now make it possible to generate, store and share data remotely, in real time and at low cost. There is an exponential mass of medical data coming from the patients themselves. The collection and use of this real-life evidence (Real World Evidence, RWE), as they are called, and patient-reported outcomes (PROs) are required to complement the results obtained by conventional randomized controlled trials. ”All clinical and post-marketing research will be modified,” in Ingrid’s opinion. "Digital tools will make collecting and using this information much easier and faster than paper-based methods. This will radically change the context in which clinical and post-marketing studies are carried out," explains Ingrid Maes, a specialist in development strategy, market analysis and management of innovation in the life sciences sector..
Fueling innovation
For the pharmaceutical industry, this evolution brings many opportunities and potential progress. "The use of these data will help to achieve several objectives," confirms the CEO of Inovigate. "For example, it will be possible to set up true 'Disease Management', treatments that are more personalized to the patient. Real world evidence may also help to increase the effectiveness of a treatment or be used to monitor its effectiveness over time, thus meeting the growing demands for outcome-based payments," explains Maes. "Results management is another possible application of RWE, as well as the development of new products and solutions based on the information they collect. This is the case for populations whose treatment is not optimal today. In this area, the feedback that these data will generate is likely to fuel innovation."
Facilitated consent
Another specific advantage of digital technologies over "good old" paper is their ability to collect easily and quickly the daily feedback of patients. A gold mine of information that is increasingly needed by the pharmaceutical industry to meet the growing demands of health product evaluation regulations. "The patient's consent is the key element in this regard. It is necessary to collect and use this information. Digital technologies make it easier to organize this agreement, in the form of a dynamic e-consent, which allows the patient to give or withdraw consent at any time. This makes it easy for companies to engage in dialogues," notes Ingrid Maes. As we can see, new digital technologies and the use of RWE also opens the door to a patient-based model of consent. "The decision will no longer be in the hands of the doctor or health professional, it will be the patient’s. We are moving towards empowering the patient."
The RWE, a factor of commercial success!
Having access to this data is therefore essential for companies active in the field of life sciences, says our expert. "The race for results will be the new challenge for pharmaceutical companies. Access to patient data and the opportunity to optimize treatment will lead to better results. The data will therefore become a determining factor of commercial success. Companies that have developed a strategy early enough will dominate the market!"
Some obstacles still hinder the use of RWE. "These are mainly technical barriers, such as the problems of connection and interfacing between different systems, the legal constraints of consent, and the ease or unease with which data is accessible and reusable. In order for them to be exploited, they must be organized in a practical way," says Maes, Inovigate's Managing Director. "Obviously, none of these obstacles are insurmountable. More and more systems are able to communicate with each other and make it possible to access and cross-reference data from different sources, making patient-controlled consent management even more essential. This is the case for certain platforms, such as Andaman7, which now incorporates a consent management component, and thus allows better control of consent."
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Recommended articles : Real World Evidence: a new benchmark for medical innovation & Opening up to real world evidence : a necessity !
