AARDEX Group

Author Archives: Bernard Vrijens

Drug Forgiveness and Patient Adherence

Exploring the Relationship Between Drug Forgiveness and Patient Adherence

With patient adherence thought to be lower than 50% 1, drug companies are increasingly maximizing dosages to bridge the gap at population scale – but are we overdosing individual patients as a result? The industry’s tendency to always aim for the … Read More

FDA Diversity Guidance

FDA Issues Draft Diversity Guidance to Improve Enrollment of Participants from Underrepresented Patient Populations

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

Protocol Deviations in Decentralized Trials

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

FDA DHT Guidance | AARDEX Industry Insights

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

FDA DHT Guidance

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In December last year, the Food and Drug Administration (FDA) issued new draft guidance (Digital Health Technologies for Remote Data Acquisition in Clinical investigations) on what kinds of devices and software may be used for remote monitoring of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

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

FDA Issues Proposed Guidance for the use of Digital Health Technology in Clinical Investigations

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 patient adherence in clinical trials

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

Case for Measuring and Managing Patient Adherence

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