Tagged: Adaptive

Tips for Success in Large Subject-Based IVD Studies

In development of IVDs, the transition to large subject-based studies is a major milestone in progress toward marketing approval. The test product has proven itself in reproducibility and validation studies, often involving banked samples. The developer can see years of effort at last culminating in revenue generation.  Only one step remains – a large subject-based… 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 »

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 »

Predicting the Future of Your Next Clinical Trial

A lot of people think the past predicts the future. I guess if you don’t have anything better, then there’s some truth to that. Recently I got a solicitation from Quintiles telling me just how valuable their database of past history is. You’ve probably heard the same promises – we know which sites produce, what… Read more »

A Peek at Real-World Performance in Clinical Trials

If you outsource clinical trials, you have no doubt noticed that all CROs claim to increase efficiency and reduce timelines, cost and risk. Since everybody has solved these problems, it’s something of a mystery how clinical research continues to experience so many delays, such high costs and so many failed programs. Opportunities for third-party validation… Read more »