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The Literature Isn’t Just Biased, It’s Also Late to the Party
Animal studies of drug efficacy are an important resource for designing and performing clinical trials. They provide evidence of a drug’s potential clinical utility, inform the design of trials, and establish the ethical basis for testing drugs in human. Several recent studies suggest that many preclinical investigations are withheld from publication. Such nonreporting likely reflects…
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Uncaging Validity in Preclinical Research
High attrition rates in drug development bedevil drug developers, ethicists, health care professionals, and patients alike. Increasingly, many commentators are suggesting the attrition problem partly relates to prevalent methodological flaws in the conduct and reporting of preclinical studies. Preclinical efficacy studies involve administering a putative drug to animals (usually mice or rats) that model the…
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Tea Leaves: Predicting Risk and Benefit in Translation
Every early phase trial begins with a series of predictions: that a new drug will show clinical utility down to road, that risks to study volunteers will be manageable, and perhaps, that patients in trials will benefit. Make a bad prediction here, and people potentially get hurt and resources wasted. So how good a job…
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Conditions of Collaboration: Protecting the Integrity of the Scientific Enterprise
So what does it take to keep medical research a well-oiled enterprise that efficiently and effectively delivers cures? Lots of cooperation–or so I argue, along with co-authors Alex John London and Marina Emborg in a piece appearing in Science [a publicly accessible version of the essay is available at Science Progress]. Unfortunately, we argue, the…
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Filing Cabinet Syndrome: The Effect of Nonpublication of Preclinical Research
Much has already been said about Filing Cabinet syndrome in medical research: the tendency of researchers to publish exciting results from clinical trials, and to stash null or negative findings safely away from public view in a filing cabinet. Nonpublication distorts the medical literature, because it prevents medical practitioners from accessing negative information about drugs.…
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Mice- Three Different Ones: Towards More Robust Preclinical Experiments
One of the most exciting and intellectually compelling talks thus far at the American Society of Gene Therapy meeting was Pedro Lowenstein’s. A preclinical researcher who works on gene transfer approaches to brain malignancies (among other things), Lowenstein asked the question: why do so many gene transfer interventions that look promising in the laboratory fail…
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STAIRing at Method in Preclinical Studies
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…
