The pharmaceutical industry has spent years discussing patient centricity. But a new reflection paper from the European Medicines Agency (EMA) suggests something much more significant is happening: Patient experience data (PED) is evolving from supportive information into a structured component … Read More
Author Archives: Oksana Pidmogylna
A capital idea: Is private equity set to positively influence clinical trials?
A few eyebrows were raised in earlier this year when Bristol Myers Squibb (BMS) announced the details of a noteworthy new partnership with investment firm Bain Capital. The agreement will see the creation of an entirely new, fully independent and … Read More
PK data problems: When trust in the model obscures truth in the trial
In a democratic society, elections are held up as powerful indicators of the will of the people. But, strictly speaking, that it is not the case. In fact, elections indicate the will of some of the people – namely, those … Read More
What’s the endpoint? How the FDA is prompting a rethink of survival in oncology trials
This August (2025), the U.S. Food & Drug Administration (FDA) set out draft guidance that could significantly impact the future of clinical trials focused on oncology treatments. Building on recent cross-industry discussions around endpoints, the 18 page document details several … Read More
Converging on the continuous: How drug exposure and patient outcomes are aligning in a data-rich future for clinical trials
So strong is the human allegiance to the status quo that it is rare for the momentum of change not to be accompanied by frictional forces of resistance. Rather than running towards new ways of working, our natural instinct typically … Read More
MEMS AS®: The Foundation of Digital Patient Adherence Monitoring in Clinical Trials
What Is Patient Adherence and Why It Matters According to the World Health Organization (WHO), “adherence to long-term therapies is the extent to which a person’s behavior, taking medication, following a diet, and executing lifestyle changes corresponds with agreed recommendations … Read More
The Practice-Protocol Paradox: Exploring problematic assumptions around medication adherence in clinical trials
Understanding the Practice-Protocol Paradox in Medication Adherence As humans, the unconscious act of making assumptions is inherent in our DNA. These mental shortcuts are deeply wired into our brains as a way of quickly making sense of the world around … Read More
Flawed dosing and forgiveness failings in the battle against adherence errors
The perfectionists among us might outwardly disagree, but, in truth, even they would secretly admit that it is not possible to live a life free from mistakes. We are complex beings living and working in complex environments and, therefore, we … Read More
Electronic monitoring in clinical trials: a guide for sponsors and CROs
Clinical trials rely on accurate data. But what if one of the most important variables whether a patient actually takes the medication is based on guesswork? Traditional methods like pill counts, diaries, or verbal confirmation have long been the standard, … Read More
How poor adherence skews clinical trial results and what to do about it
Imagine spending years developing a promising new treatment, only to have its potential clouded by something as simple (and as overlooked) as whether or not people actually took their pills. This isn’t just a small glitch in the process. In … Read More