Topic: Decision Making

Risk-Based Monitoring Update: a Message from the RBM Soapbox

As readers of this blog know, Health Decisions embraces risk-based monitoring. Nevertheless, we keep an eye out for issues encountered in the field. A recent post by Nadia Bracken in her RBM Soapbox feature at ClinOpsToolkit raises an important issue sometimes encountered when putting risk-based monitoring into practice. Nadia writes as follows:      Every time I… Read more »

Amgen’s Near Miss and Maximizing Biotech Success Rates

The near miss by Amgen’s T-Vec viral cancer vaccine of the secondary endpoint of increasing overall survival in subjects with metastatic melanoma is a reminder of the slender margin between success and failure in biopharma clinical development. The p-value of 0.051 for the endpoint came within a whisker of the magic 0.05 but headlines still… Read more »

The Next 25 Years in Clinical Research: Learning to Learn Faster

Missed Opportunities to Advance Clinical Research 605 BCE In Nebuchadnezzar’s court, Daniel and friends conducted a controlled trial comparing the effects of a meat-and-wine diet to Daniel’s preferred fare of lentils and water. King James Bible, Daniel Chapter 1 560-547 BCE Croesus, King of the Lydians, conducted a blinded controlled test of the accuracy of… Read more »

Why Small Is Beautiful in Clinical Development

Developing targeted therapeutics is a smart way to increase the woeful success rates in clinical development and the JP Morgan Healthcare Conference, as described in “Pulse of J.P. Morgan 2014” from Fierce Biotechnology, showed that many companies are adopting this strategy. However, as this blog has previously discussed, developing targeted products, and especially orphan drugs,… Read more »

What Presidential Elections Can Teach Pharma

Quantitative methods had a field day predicting the US presidential election November 6, making political pundits look silly. The election “quants” outperformed the pundits using both Bayesian predictive probabilities and frequentist methods. Those of us in clinical development should take a lesson. Elections and pharma development are all about decisions—voters deciding how to cast their… Read more »

Actionable Information: What You Don’t Know about Your Trial but Should

I’ve repeatedly emphasized the importance of timely, actionable information in increasing the efficiency of clinical trials. When I do talks, I often discuss this in some detail but readers sometimes ask exactly what sorts of information I’m talking about.  So let’s look at some key performance metrics for site performance and then move on to… Read more »

Technology, Information, and Decision Making

The decline in pharma productivity—an astounding 33% per year for the past 30 years1—has generated a great deal of hand-wringing but little in the way of suggestions about how to improve the situation. Why, for example, has the substantial investment in technology (primarily in web-based electronic data capture) not helped productivity?  This problem is hardly… Read more »