Author Archives: Bernard Vrijens

Placebo and adherence: Is a complicated relationship compromising clinical trial effectiveness?

In 1920, The Lancet published a paper authored by T.C. Graves entitled ‘Commentary on a case of hystero-epilepsy with delayed puberty: Treated with testicular extract’. While the article was not the first to mention the placebo effect, it is recognised … Read More

Enhancing Medication Adherence in Rare Disease Clinical Trials

In observance of Rare Disease Day, it is imperative to underscore the progressive strides within the domain of rare disease research. Rare diseases, characterized by their infrequent occurrence within the general populace, impose significant burdens not only on the affected … Read More

How Medication Adherence Packaging is Transforming Clinical Trials and why FDA Approves

Drug trials are conducted to evaluate the safety and efficacy of new or investigational drugs. The primary goal of drug trials is to determine if a new drug is effective in treating a particular medical condition and if it is … Read More

Why Objective and Granular Digital Adherence Monitoring is Gaining Traction in Trials.

“Objective and granular” digital adherence measures could improve trial efficiency and allow for better-informed decisions on the efficacy and safety of new drug products. That’s according to the authors of a literature review that looked at more than 100 medicines … Read More

Medication Technology: Bridging the Gap Between Drug Trials and Real World

With the current push for increased diversity in research, the medical community has accepted the challenge to make trial populations more representative of those in clinical practice. Yet poor medication adherence, which clouds the view of how drugs work in … Read More

Why Near-Perfect Medication Adherence Often Equates to Toxicity.

The World Health Organization (WHO) has recently highlighted how poor adherence can lead to poorer outcomes for prisoners, contributing to health inequalities the world over. But it is worth noting that near-perfect adherence can be just as troublesome within the … Read More

Challenging the Status Quo for Measuring Medication Adherence in Clinical Trials

Poor adherence to the investigational product can bring even the most carefully planned clinical trial to its knees. It is time to accept that traditional approaches such a pill count do not work. We need to upset the status quo … Read More

Therapeutic Drug Monitoring: The Difference Between Accurate and Reliable

Adherence to medication during clinical trials is a problem of striking magnitude, and one that researchers have employed therapeutic drug monitoring (TDM) to solve for years. But the approach, which measures the level drug or drug metabolites in patients’ blood, … Read More

Measure to Manage: How Data-Driven Feedback Drives up Patient Adherence in Clinical Trials

Every clinical trial participant with poor medication adherence will have their own set of complex reasons for not taking their medications as prescribed – meaning there is no one size fits all solution. Instead, sponsors should take a data-driven approach … Read More

Setting the Stage for Better Medication Adherence in Clinical Trials

When clinical trial participants do not follow the dosing protocol, it can result in an underestimation of a drug’s therapeutic effect. With inability to demonstrate efficacy being the leading cause of study failure worldwide1, it’s an issue sponsors cannot afford … Read More