Tagged: Adaptive Monitoring

Clinical Research Now: One Foot in the 21st Century, the Other in Ancient Greece

We do 21st century biology in our laboratories and then do clinical trials that Hippocrates would have been quite comfortable with.  – Roger Perlmutter, executive vice president of Merck and president of Merck Research Laboratories, in a panel discussion at the Forbes Healthcare Summit in October. Perlmutter’s characterization of current clinical trials rings true.  Much… Read more »

AMP Foreshadows Higher Clinical Trial Success Rates Despite Growing Complexity

A key focus at this year’s AMP conference is Next Generation Sequencing (NGS), transformative first for diagnostics but increasingly for biopharma development and patient care. Rapid progress in NGS is essential for development of many oncology drugs. You also see ample evidence at AMP that NGS will drive remarkable advances across the therapeutic spectrum. NGS… Read more »

Risk-Based Monitoring: Where are the Benefits?

I got a call this morning from a frustrated colleague who runs the oncology franchise in Europe for a big pharma company. Despite a substantial investment in software that promised increased focus and efficiency through risk-based monitoring, my colleague is seeing neither. Did I have any suggestions? Questions about why technology is not producing expected… Read more »

White Paper on Biologics Development Available for Download

The current boom in biotech IPOs makes it more important than ever for biologics developers to define safety and efficacy early and chart the proper course to market. As promised in last week’s post, our white paper on meeting the unique challenges of biologics trials is now available for download. Reducing Risk in Biologics Trials:… Read more »

Monitoring Article Goes Live in Journal of Clinical Research Best Practices

The article about risk-based monitoring that I mentioned a couple of weeks ago is now online. “Adaptive Monitoring: Risk-Based Monitoring and Beyond” appears in the September issue of the Journal of Clinical Research Best Practices.  Norman Goldfarb, the editor, keeps a close eye on trends in clinical development. He had this to say about the… Read more »

CNS Development Makes a Comeback

Only yesterday, we were reading about the death of CNS drug development.  The reasons were simple: first, several Big Pharma companies were abandoning or cutting their CNS programs; and second, there seemed to be a consensus that odds were against translating CNS-related innovations in basic science into successful clinical programs. That was in December 2011…. Read more »

Adaptive Monitoring Approach Nets Independent Validation

I am writing this post from the beautiful Broadmoor resort in Colorado Springs where I attended a gala  to accept the 2013 CIO Award honoring Health Decisions’ adaptive monitoring technology. COO Alicia Paladin provided many insights that contributed to the success of our adaptive monitoring project and joined me at the gala. All of us… Read more »

The FDA’s Final Risk-Based Monitoring Guidance and Beyond

The FDA has issued the final version of its risk-based monitoring guidance. In my view, this represents a milestone in industry and regulatory understanding of the extent to which electronic systems can increase the efficiency of clinical trials while maintaining data quality and patient safety. The guidance does not dismiss the value of site visits,… Read more »