Tagged: Adaptive Operations

Reflections on James Lind’s Scurvy Trial, Pharmacoeconomics, Sovaldi and Other Hot Topics in Clinical Research

Yesterday we celebrated May 20 as International Clinical Trials Day because James Lind started his famous trial of scurvy treatments on this date in 1747. Lind’s study remains noteworthy as perhaps the first controlled study that demonstrated the efficacy of a treatment that is still known to be effective. Lind conducted the multiarm trial aboard… Read more »

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 »

Looking Ahead: Reducing Risk in Biologics Trials

Despite their complexity, biologics are going mainstream. According to a report by Evaluate Pharma, biologics represent 40% of development pipelines for companies they surveyed. You might even say biologics programs involve lower risks than small-molecule programs – a higher percentage of biologics progress from preclinical to approval. But going mainstream hasn’t made biologics more predictable…. Read more »

Why Not Continuous Development?

While development of pharmaceutical products has traditionally followed a phased approach, a continuous model of development is possible and offers substantial reductions in development timelines and risk. Historical chokepoints demanded a “batched” approach during trials and between phases.  Many things have changed, but the chokepoints largely remain. It’s time to do something about them. The… Read more »

Are Your Clinical Operations Adaptive-Ready?

The Adoption and Impact of Adaptive Trial Designs, a new report from the Tufts Center for the Study of Drug Development, confirms something that I’ve been saying for years – you can’t use adaptive designs without highly efficient operations: Operating concerns – specifically delays and disruptions in trial execution, patient participation and distribution of clinical… Read more »