Director of FDA: strengthen the participation of patients in FDA supervision

Source: Dr Scott Gottlieb, director of FDA of drug age 2017-10-12 (picture source: fierce biotech), issued a statement on FDA's new measures to further strengthen the supervision of patient participation agencies FDA establishes a patient participation Advisory Committee The first meeting was held successfully The function of patient's tissue is formalized, so it is more and more important Integrate the real world evidence into the regulatory decision-making process Since then, in addition to RA (Regulatory Affairs), MA (Medical Affairs), GA (Government Affairs), PA (patient Affairs) will become a hot word! This latest action of FDA is worth learning from! On October 11, 2017, the U.S Food and Drug Administration (FDA) held a pioneering activity: the first meeting of patient engagement Advisory Committee (peac) This is an important step forward in FDA's efforts to expand contact with patients and an important milestone in deepening patients' participation in FDA regulatory activities This is the FDA's first Advisory Committee composed entirely of patients, care partners, and advisory committees representing their needs Founded by the FDA's device and radiation health center (CDRH), it reflects the commitment of CDRH to place patients at the center of their work FDA's work requires us to establish objective and consistent standards on which we make decisions But in the end, the criteria we use to judge benefits and risks are patient-centered and most important to patients It is essential that end users, patients, participate in identifying health priorities and outcomes for health interventions This requires culture and processes to ensure that these patient perspectives are integrated at every critical stage of product development CDRH is working with a number of external partners to encourage the inclusion of patient perspectives throughout the life cycle of medical devices, from the concept and design of medical devices to the clinical trial process, and throughout the post marketing evaluation This includes new guidance on patient preferences in several areas: pre market approval (PMA), humanitarian device exemption (HDE) applications, head-on requests, and inclusion in device labels The guidelines describe how patient tolerance for risk and perspectives on benefits can be considered as part of FDA's assessment of the benefit risk of certain devices Today's meeting focuses on the whole process of involving patients in clinical trials, from clinical trial design to recruitment, to enrollment and retention, and how FDA exchanges clinical trial results CDRH has been committed to a wide range of instruments, from prosthetics to minimally invasive surgical instruments for the treatment of glaucoma, to promote relevant development work, including patient preference research and measurement of results reported by patients CDRH is also responsible for integrating real-world evidence into FDA's regulatory decision-making process, and issued a real-world evidence guide two months ago The guide encourages stakeholders to use electronic health records, insurance claims databases and registration information to facilitate more effective regulatory decisions Patients are increasingly collecting these real-world data Patients are taking the lead in creating new registration platforms that collect health data to track their progress and facilitate the evaluation of medical products We are fostering interaction with these patient led registries to help them become tools for regulatory change The rapid development of smart phones makes it possible to create a platform, which makes it easier for patients to master their health information It also allows us to use this information more to advance regulatory decisions and product science This is particularly relevant, especially as more information is being collected in the real world, reflecting the patient's experience more closely This gives us a new and valuable understanding of technical performance The bottom line is: when evaluating effective scientific evidence that the potential benefits of the device outweigh its potential risks, FDA can also use strict, systematic collection of patient preference information as part of the overall evidence from clinical and non clinical trials One of the tasks of the committee is to help us develop parameters to assess these issues How does this preference information meet the right criteria to be relevant to our decision? The FDA will take more measures to cover the entire FDA in the next few months to strengthen these and other efforts One of them is the creation of a new team to coordinate patient engagement related multicenter projects across the FDA The goal of this new patient Affairs (PA) team is to better utilize and expand the relationship that our medical product center has established directly with the patient organization This is not about creating a single "front door" or a new "door" for the patient's organization to contact the FDA Groups that are already directly related to our medical product center will maintain the existing interaction Our goal is to get the patient group directly in touch with the review program For groups that don't know how to approach the FDA, this new department can serve as an initial entry point The broader goal is to promote cross center policy-making and help us develop more consistent, cutting-edge approaches to bringing patients' perspectives into our scientific processes We need to improve the scientific nature of these efforts and formulate some basic and universal practices and principles With the development of the science of measuring patients' preferences, our policies must also be adapted and adjusted Our goal is to promote the development and use of patient-centered methods in more parts of regulatory activities, and to develop and improve universal standards for integrating patient voice as a scientific issue into product development Some of the long-term goals of these new efforts are to establish a consistent approach to understanding how FDA develops clinical outcome assessment tools, such as patient reported outcomes, to help our regulatory decisions Another goal is to maintain a strong data management system to incorporate and formalize knowledge sharing among patient stakeholders, patient groups, and FDA The new patient affairs team reflects FDA's commitment to improving the position of patients in its regulatory work The Advisory Committee we set up today is another concrete measure to fulfil that commitment.