Tagged: operations

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 »

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 »

Faster to Market, Faster to Fail

The team at Health Decisions enjoys nothing more than helping a sponsor bring a successful product to market months or years ahead of schedule. Through a combination of adaptive design and adaptive operations, we have succeeded in accelerating market entry for many products, sometimes by more than two years, as in the case of one… 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 »

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 »