Author: Jonathan Kimmelman

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

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

Attrition in drug development – that is, the failure of drugs that show promise in animal studies to show efficacy when tested in patients- is often viewed as a source of inefficiency in drug development. Surely- some attrition is just that. However, in our recent Feature article in eLife, my long time collaborator Alex London… Continue reading Why clinical translation cannot succeed without failure

Most trials are funded by public sponsors, charities, or private drug developers. Austere research funding environments, and growing engagement of patient communities, has encouraged many to seek alternative funding.  One such alternative is patient funding. In the August 6 issue of Cell Stem Cell, my co-authors Alex London and Dani Wenner ask whether “patient funded… Continue reading Is it ok for patients to pay for their own clinical trials?

If you could change one thing- and only one thing- in preclinical proof of principle research to improve its clinical generalizability, what would it be? Require larger sample sizes? Randomization? Total data transparency? In the May 2014 issue of PLoS Biology, my co-authors Uli Dirnagl and Jeff Mogil offer the following answer: clearly label preclinical… Continue reading Search, Bias, Flotsam and False Positives in Preclinical Research

I first met Kathy in August 2001 when, newly arrived in Montreal with a totally useless PhD in molecular genetics, I approached her, hat in hand, looking for a postdoctoral position in Biomedical Ethics. Actually, my hat wasn’t in hand- it was on my head- I had a week earlier accidentally carved a canyon in… Continue reading In Memorium for Kathy Glass

A growing number of drug trials are collecting tissue to determine whether the drug hits its molecular target.  These studies are called “pharmacodynamics.”  And in cancer, many pharmacodynamics studies involve collection of tumor tissue through biopsies.  These procedures are painful, and are performed solely to answer scientific questions.  That is, they generally have no diagnostic… Continue reading Missing Reports: Research Biopsy in Cancer Trials