Archive for March 2022
Industry Stakeholders Respond to FDA’s Draft Digital Health Technology Guidance
In December last year, the Food and Drug Administration (FDA) issued new draft guidance (Digital Health Technologies for Remote Data Acquisition in Clinical investigations) on what kinds of devices and software may be used for remote monitoring of clinical trial participants to ensure the data is sufficient to support a product application. The FDA invited…
Read MoreInnovative Health Initiative Pledges to Help Break Silos Between Basic Research, Medical Disciplines, and Technological Areas.
Technology presents the healthcare community with a golden opportunity to improve lives – but only if we embrace that potential. Success, according to the Innovative Health Initiative’s Strategic Research and Innovation Agenda, depends on cross-sector collaboration. Across Europe, healthcare faces a multitude of challenges. The region is home to an aging population, living with a…
Read MoreSupporting Adherence in Clinical Research with easy to use, Evidence-Based Medication Adherence Tools
Clinical research can stand or fall on the adherence to trial medications – even the most efficacious interventions will fail if people do not take their medicines as prescribed. That’s why researchers from the University of Sydney and the University of New South Wales, Australia used AARDEX’s digital solutions to verify adherence to medication among…
Read MoreFDA Issues Proposed Guidance for the use of Digital Health Technology in Clinical Investigations
In recent years, a multitude of Digital Health Technologies (DHTs) have emerged, many with the ability to solve some of the biggest problems in clinical trials. However, uptake has been slow. Now, proposed new Food and Drug Administration (FDA) guidelines could change all that by finally giving sponsors, contract manufacturing organizations (CMOs), and contract research…
Read MorePaving the Way for Optimal Patient Adherence in Clinical Research
For far too long, poor patient adherence has been the elephant in the room. The common, age-old problem has the potential to bring a clinical trial to its knees, and yet with no workable solution on the table, sponsors and CROs have been forced to ignore it. But that’s changing. Integrating advanced technologies, including smart packaging (smart…
Read MoreThe Case for Measuring and Managing Patient Adherence
According to the World Health Organization, up to half of the patients with chronic diseases fail to take their medications properly.1 Research shows many patients who are part of clinical trials do not maintain medication adherence either.2 Among many things, poor patient adherence is an ongoing threat to drug development. Typically, by month 12, 40% of participants have…
Read MoreRemoving the Barriers that Hinder Patient Adherence
Poor patient adherence tends to be a matter of people not taking their medicine as prescribed, due to access barriers. So how can placing an additional burden on patients be the answer? As an industry, we are more than aware of the scale and consequences of non-adherence to medication, both in routine care and clinical…
Read MoreAARDEX Group Joins Innovative IT4Anxiety Project
Innovative medication adherence tools in a real-world hospital setting to reduce anxiety in users of mental health services. Liege, Belgium – March 3, 2022: Belgium-based AARDEX Group, the global leader in Digital Tools for measuring and managing adherence to medication, today announced they have joined the IT4Anxiety project – supporting the implementation of innovative solutions to reduce the anxiety…
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