Tagged: decision making

Tilting the Playing Field in Clinical Development

Recent discussions with a large sponsor were a pleasant reminder that big doesn’t have to mean backward. This progressive company has made a start at adaptive (risk-based) monitoring. The goal of the clinical team is to achieve equal or better data quality at lower cost while prioritizing critical data and reducing timelines. One reason that… 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 »

DSMBs and Business Decisions in Clinical Research

Interim reviews in clinical trials have always been controversial in some circles because they require somebody to look at otherwise confidential data while a trial is in progress, raising the possibility of introducing bias. On the other hand, not letting anybody see interim data is a great way to have a trial with serious issues… 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 »

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 »

The Importance of Information-Flow: The Case of the Thwarted Startup

In my last post, I discussed the cultural problem of excessive risk-aversion preventing pharma and CROs from using methods that could improve R&D productivity. This issue is never more evident than when applied to the critical area of information flow and decision making. Here’s an example of how a potentially important drug failed in a… Read more »