Tagged: agile

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 »

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 »

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 »

The Busy Executive’s Guide to Agile Clinical Development

The Agile approach to clinical development just racked up another success. A >3000- subject pivotal study just passed a major enrollment milestone well ahead of schedule. The same study has seen simultaneous reductions in SDV% and error rates. If you are having similar experiences with your studies, please take a moment to share information about… Read more »

Metrics, Motivation and Site Performance in Clinical Trials

I am pleased to announce a second guest writer for Trials without Tribulations. Allyson Cygnarowicz is a project manager at Health Decisions with more than 13 years of experience in clinical research, including phases I through IV pharmaceutical studies and all levels of pre- and post-market device studies. She has a particularly strong background in… Read more »

When Blockbuster Costs Meet Boutique Revenues

The transition to personalized medicine is gathering momentum, but the high cost of clinical development remains a barrier between the pharma industry and a secure path to a profitable new era.  Development costs will have to shrink dramatically as blockbusters dwindle and products for small or in many cases very small markets take center stage…. Read more »

Why Hasn’t Technology Paid Off in Clinical Research?

There’s a telling figure at the end of an April 2012 discussion paper from The Institute of Medicine of the National Academies, “Transforming the Economics of Clinical Trials.” The authors, Judith M. Kramer and Kevin A. Schulman of Duke University, sum up the disappointing results to date of adopting new technologies in clinical research, with… Read more »