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Today STREAM just uploaded its first manuscript into medRxiv, a preprint server. The manuscript, which can be accessed here, traces the clinical development process of a very uninteresting cancer drug you never heard of, ixabepilone (approved in USA, not in Europe). Our goal was to estimate the total patient benefit and burden associated with unlocking… Continue reading STREAM goes Preprint with an Analysis of the Development of the Anti-cancer drug Ixabepilone

In my previous post, I offered some reflections on my recent paper (with Marcin Waligora and colleagues) on pediatric phase 1 cancer trials. I offered three plausible implications. In this post, I want to highlight two reasons why I think it’s worth facing up to one of the possible implications I posited- namely (b) a… Continue reading Risk/Benefit in Pediatric Phase 1 Cancer Trials: Noble Lie? (part 2)

In years of studying the ethics of early phase trials in patients- for example, cancer phase 1 trials- I’ve become more and more convinced that it is a mistake to think of these trials as having a therapeutic impetus. To be sure- the issues are complex, many people who share my view do so for… Continue reading Risk/Benefit in Pediatric Phase 1 Cancer Trials: Noble Lie? (part 1)

How well can researchers accurately predict whether high profile preclinical findings will reproduce? This week in PLoS Biology, STREAM reports the result of a study suggesting the answer is “not very well.” You can read about our methods, assumptions, results, claims, etc. in the original report (here) or in various press coverage (here and here).… Continue reading The Back Story on “Can cancer researchers accurately judge whether preclinical reports will reproduce?

In my experience, peer review greatly improves a manuscript in the vast majority of cases. There are times, however, when peer review improves a manuscript on one less important axis, while impoverishing it in another more important one. This is the case with our recent article in Annals of Neurology. Briefly, our manuscript created a… Continue reading Nonpublication of Neurology Trials for Stalled Drugs & the Ironic Nonpublication of Data on those Stalled Drugs

A year ago, I received a message from Anna Powell-Smith about a research paper written by two doctors from Cambridge University that was a mirror image of a post I wrote on my personal blog1 roughly two years prior. The structure of the document was the same, as was the rationale, the methods, and the… Continue reading Recapping the recent plagiarism scandal

Scientific results are inherently uncertain. The public views uncertainty differently than scientists. One key to understanding when and how scientific research gets misinterpreted is to understand how the public thinks about scientific uncertainty. A recent paper in the Journal of Experimental Psychology: General explores how laypersons perceive uncertainty in science. Broomell and Kane use principle component… Continue reading Scientists should be cognizant of how the public perceives uncertainty

Since the 1960s, the U.S. FDA has served as a model for drug regulation around the world with its stringent standards for approval of new drugs. Increasingly, however, a coalition of libertarians, patient advocates, and certain commercial interests have been pressing for a relaxation of these stringent standards. Examples of legislative initiatives that would weaken… Continue reading Accelerated Drug Approval and Health Inequality

Despite the appeal of personalized medicine (that is treatment selection based on the presence of a particular marker), uncertainty remains regarding the broad utility of this selection strategy in oncology. A recent meta-analysis by Jardim et al. in the Journal of the National Cancer Institute attempted to provide some clarity by comparing efficacy outcomes between personalized… Continue reading Shedding (Dim) Light on Clinical Benefit in Biomarker-Based Drug Development