Topic: Risk

Saluting Trial Participants on International Clinical Trials Day

In observing International Clinical Trials Day for 2017 on May 19, Health Decisions wishes to thank all those who participate in clinical trials. Health Decisions especially thanks patients enrolled in our current trials but we want to thank trial participants everywhere for making clinical development possible. While sponsors and CROs like Health Decisions make every… Read more »

New White Paper: Top 10 Clinical Development Trends for 2015

With Q4 2014 upon us, it is time to gear up for 2015. A few things are clear. Clinical development will continue to evolve against a pattern of high-failure rates for products aimed at large populations and higher success rates for targeted therapies. Orphan Drug development will remain an area of intense activity with continued… Read more »

Drug Development: Navigating from Molecule Selection to Market

Life-science VCs are great at vetting molecules and identifying target markets for novel drugs and biologics. If VCs have a weak spot, it is in the area where 80% of novel therapeutics die – clinical development. Like many biotech and pharma executives, VCs tend to think candidate selection largely determines whether new products achieve marketing… 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 »

Leveling the Playing Field in Orphan Drug Development

Trials of orphan drugs often involve smaller sample sizes. How much smaller? Cut the typical phase 3 sample size by 75% and then, for many orphan trials, cut a lot more. The Evaluate Pharma Orphan Drug Report 2013 provides valuable data on sample size in phase 3 orphan trials. While the median size was >500… Read more »

Tilting the Playing Field in Clinical Development

Recent discussions with a large sponsor were a pleasant reminder that big doesn’t have to mean backward. This progressive company has made a start at adaptive (risk-based) monitoring. The goal of the clinical team is to achieve equal or better data quality at lower cost while prioritizing critical data and reducing timelines. One reason that… Read more »