Diversity in clinical research is a growing concern for sponsors as many factors can influence how an individual may react to certain drugs: age, biological sex, disabilities, chronic comorbidities, geographical location, gender identity, race, and ethnic background. Thus, if the … Read More
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Optimizing Study Design to Tackle Protocol Deviations in DCTs
Decentralized Clinical Trials (DCTs) are here to stay, as demonstrated by international regulators’ recent commitments to the model. But while the approach offers a multitude of benefits, from expanding access to increasing cohort diversity, it can also serve to magnify … Read More
Harnessing Digital Health Technology to Bolster Study Power
In a world of big tech, data is king. This slogan is far from news for the Biopharmaceutical Industry, but clinical trials are lengthy, complex, and expensive, meaning precious information isn’t always utilized to its maximum potential. In recent years, … Read More
AARDEX Industry Insights: Pharma Responds to FDA’s Draft DHT Guidance | EU Clinical Trials Regulation
It’s hard to believe that we are already a full quarter into 2022 – and a busy one it’s been -particularly for the regulatory landscape. AARDEX® Group also announced the first in a series of virtual events, a live panel debate … Read More
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In December last year, the Food and Drug Administration (FDA) issued new draft guidance (Digital Health Technologies for Remote Data Acquisition in Clinical investigations) on what kinds of devices and software may be used for remote monitoring of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 … Read More
Innovative 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 … Read More
Supporting 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 … Read More
FDA 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 … Read More
Paving 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 … Read More
The 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 … Read More