Tagged: information flow

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 »

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 »

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 »

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 »