Medical research, we all know, is highly prone to bias. Researchers are, after all, human in their tendencies to mix desire with assessment. So too are trial participants. Since the late 1950s, epidemiologists have introduced a number of practices to clinical research designed to reduce or eliminate sources of bias, including randomization of patients, masking… Continue reading STAIRing at Method in Preclinical Studies
Author: Jonathan Kimmelman
The Octopus of Reference Standards
When gene transfer researchers perform an experiment, how do they measure the dose of their vectors? For that matter, when investigators perform a study using any novel biologic, how have they characterized their agents? Few would think the questions are ethically significant. But consider the fact that research teams often use different techniques to determine… Continue reading The Octopus of Reference Standards
The Octopus of Reference Standards
NOTES from the Underground
Surgical innovation has always been a problem for medical ethics. Surgeries are unregulated, and partly as a result, few are introduced to clinical practice having been validated in randomized controlled trials. Moreover, attempts at novel surgeries typically fly beneath the radar of ethical review, because they are viewed as innovative clinical practice rather than research.… Continue reading NOTES from the Underground
The Long and Winding Road(map)
The research team led by John Ioannidis has, for my (evaporating) money, done some of the most interesting work looking at the “epidemiology” of translational research: how often are high profile genetic linkage studies refuted? (answer: usually); to what degree are translational studies biased? (answer: a lot); how often are major scientific findings translated into… Continue reading The Long and Winding Road(map)
In the Dark?
Most cancer patients who enter phase 1 clinical trials are motivated by the prospect of controlling their cancer. Increasingly, however, such studies, in the words of one ethicist, “take without giving in return” by involving biopsy procedures in which tissue is collected before and during the study in order to gauge whether a new drug… Continue reading In the Dark?
A Thick Frosting of Science…
On September 2, the Washington Post ran a story (“Injections of Hope: Doctors Promote Offshore Stem Cell Shots, but Some Patients Cry Foul”) on an emerging global economy of stem cell medical tourism. It described how patients with conditions ranging from ALS to spinal cord injury travel to offshore clinics to receive unvalidated cell “therapies”–embryonic… Continue reading A Thick Frosting of Science…
Sell Therapy, European Style
Two side-by-side news reports in the August 21 issue of Nature spell more trouble for cell therapy in Europe. The first story follows on previous reports about Austrian urologist Hannes Strasser (see postings on Jul 23 and May 27, 2008). According to an Austrian government report, Strasser “failed to get appropriate approval for the trial… Continue reading Sell Therapy, European Style
Seeding Trials: Misled in Translation?
Translational research- defined as research aimed at bringing discoveries in the basic sciences into clinical practice, is often divided into two types: T1 and T2. This blog is almost entirely focused on the former, which involves testing laboratory discoveries in human beings. Often lost in the glitter of T1, however, is the nettlesome challenge of… Continue reading Seeding Trials: Misled in Translation?
Fazing Phase 0?
Phase 0 studies are a new class of drug trials that involve delivering tiny doses of a new drug to human volunteers to study how the drug is distributed and metabolized in the human body. Both FDA and its European counterpart, EMEA, have recently issued statements encouraging drug companies to consider ‘phase 0’ studies before… Continue reading Fazing Phase 0?