Tagged: enrollment

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 »

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 »

Three Ways to Target Inefficiency in Clinical Development

Based on years of poor R&D productivity, the pharma industry is rethinking clinical development. Novartis CEO Joseph Jimenez is rethinking the traditional blockbuster.  Tomas Philipson and former FDA Commissioner Andrew von Eschenbach are rethinking  phase III trials. A third aspect of clinical development also requires rethinking but I’ll leave that for the end of this… Read more »

Labeling: Your Map to Market

In response to the spectrum of interaction that I have experienced with this blog’s readers, I am excited to announce that guest writers from the Health Decisions staff will begin contributing to Trials without Tribulations. I will have one guest blogger each month. Health Decisions staff members with deep experience in clinical research will share… Read more »

Enrollment as a Learning Problem

The Tufts Center for the Study of Drug Development’s January/February 2013 Impact Report has stirred comment and criticism. Paul Ivsin of Placebo Control dismisses the significance of learning that 48% of sites miss their enrollment targets; Ed Silverman at Pharmalot does the reverse.  The biggest takeaway from my perspective is this: “Study timelines typically extended… Read more »

Why is Enrollment So Hard?

Although enrollment is one of the most pivotal determinants of study success, most researchers acknowledge doing poorly yet seem unable to improve their methods. As an industry, our performance is shockingly feeble: on average, a paltry 15% of studies enroll on time. In most businesses, that kind of performance would be a clear definition of… Read more »