If enacted, the US’ Right Drug Dose Now Act will place pharmacogenomics on the main stage of drug development and move us further into the personalized medicine era. By supporting the use of pharmacogenetic testing to prevent adverse events (AEs) … Read More
Author Archives: Bernard Vrijens
The Heart of the Matter: The Role of Medication Adherence Tools in Tackling the CVD Epidemic
Despite huge strides in how cardiovascular diseases (CVD) are treated in recent years, the conditions remain among the leading causes of morbidity and mortality worldwide. At least part of the problem is that even the most effective drugs will not … Read More
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 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
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
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