The Valley of Death


Applied Clinical Trials

This is an eye-catching headline, for sure. And if you are using it in clinical research as GBI Research did in releasing its latest research report, it’s definitely one of the more creative as far as market research goes. The release reiterates what is becoming glaringly obvious as far as our industry goes--Costs associated with drug development have risen from around $138 million in 1975 to over $1 billion in 2005. Clinical trials represent a major expenditure in this space…we quote around 45% of the budget. So GBI’s research looks at “why researchers in the pharma industry now refer to the clinical development process as the ‘valley of death’, which must be crossed to attain drug approval.” What do they cite as some of these issues? Longer more complex trials, falling participant enrollment and retention rates, Phase III failures of 30%. And having attended CBI’s Study Optimization conference last week, I can say that it’s true. From the struggles I heard about postmarketing CV enrollment, to compliance in birth control trial studies, to staff turnover issues among sites and CROs…there are a lot of seemingly minor issues that make this “resource-intensive” clinical trials process expensive and complex.

GBI’s report around the “Valley” is actually titled more drily, “Pathways to Efficient Drug Development—Advances in Modeling and Simulation Outcomes to Fuel Pipeline Productivity.” This topic was definitely touched on at the CBI conference. But what struck me is the Table of Contents (I can only read the summary of the report, the full report costs $3,500, so if someone buys it and wants to forward it to me, I’d be grateful, though I’m not advocating copyright violation), which lists Collaborations Aim to Tackle Major Scientific Challenges; Innovation in the Drug Development Paradigm; The Critical Path Initiative; The IOM Initiative; Collaboration in the Precompetitive  Space; Building Successful Consortia; and more. This list is by no means exhaustive of the initiatives out there, but it just brings to bear a point I made in response to a recent blog that Paul Ivsin posted about TransCelerate BioPharma, a new initiative of top 10 biopharma to address drug development bottlenecks, with study execution at the top of its list. And that is, there are many collaborations out there that are really working to effect change…some are government-funded, others company initiatives and still others facilitated by private, third-party organizations. But they are all after the same goal, to address the valley of death.

Now if you Google the “Valley of Death,” which I did when I was writing this, you get a bunch of links for the 23rd Psalm. And that prayer actually says,”… though I walk through the valley of the shadow of death.”  Which means really, you aren’t dead yet. You are just going there. So the same with the financial crisis of drug development and what it means to clinical trials and study execution. The industry isn’t dead yet, and don’t fear it. You are just going to have to get used to a lot of change.

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