Tagged: Continuous development

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 »

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 »

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 »

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 »

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 »

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 »

Clinical Development Relay: The Hurdles We Face

Now that I’ve had the chance to settle in to the blogosphere, I’d like to tell you a little more about what I hope to accomplish with “Trials Without Tribulations.” It is obvious to me (and others in the industry, see here, here, and here) that biopharma faces a number of sizable challenges. Tribulations, if… Read more »

Improving Pharma Productivity One Step at a Time

I had a rare and refreshing experience yesterday afternoon. In meeting with a startup team from a big pharma company, the subject of source data verification came up. We like to use a digital pen CRF as source data, obviating the need for source data verification, one of the most inefficient steps in the research… Read more »