The FDA, in collaboration with the NIH’s National Center for Advancing Translational Sciences (NCATS), has launched a new data-sharing app called CURE ID. The app helps healthcare professionals explore successful ‘off-label’ uses (uses not described in the approved FDA label) of existing drugs to treat neglected infectious diseases.
Healthcare professionals may choose to prescribe a marketed drug for an unapproved use when they judge that the unapproved use is medically beneficial for a patient. This is a common practice in the infectious disease space, as these patients often have no therapeutic options approved for their condition.
CURE ID can be accessed through a website, a smartphone or other mobile device and serves as an online data repository. After setting up an account, qualified clinicians can report instances in which they have used FDA-approved drugs to treat new disease indications or new patient populations or have used them in new doses or combinations. This information can then be accessed by other clinicians in the infectious disease space to help them explore promising treatment options which they may not have otherwise considered.
The development of this new platform highlights the FDA’s continued efforts to promote and facilitate real-world data generation, i.e. data regarding the safety and efficacy of a drug that is collected outside the tightly-controlled clinical trial setting.
According to the FDA, “When healthcare professionals directly input their clinical cases into the app, CURE ID allows these real-world experiences to be organised and analysed much faster.” This kind of crowdsourcing of medical information will make it easier to spot promising new uses for existing drugs, encourage further drug development, and help inform regulatory decision making.
Already, CURE ID includes data on over 325 infectious diseases and syndromes and has nearly 1,500 case reports for clinicians to access. The FDA says it has plans to actively reach out to healthcare providers, in the relevant disease space, to encourage them to use the app and benefit from/contribute to the data that it provides.
Click here to access CURE ID through the web and set up an account.