As Jonathan is fond of saying: Drugs are poisons. It is only through an arduous process of testing and refinement that a drug is eventually transformed into a therapy. Much of this transformative work falls to the early phases of clinical testing. In early phase studies, researchers are looking to identify the optimal values for the various… Continue reading The Landscape of Early Phase Research
Tag: methodology
The Ethics of Unequal Allocation
In the standard model for randomized clinical trials, patients are allocated on an equal, or 1:1, basis between two treatment arms. This means that at the conclusion of patient enrollment, there should be roughly equal numbers of patients receiving the new experimental treatment as those receiving the standard treatment or placebo. This 1:1 allocation ratio… Continue reading The Ethics of Unequal Allocation
No trial stands alone
“The result of this trial speaks for itself!” This often heard phrase contains a troubling assumption: That an experiment can stand entirely on in its own. That it can be interpreted without reference to other trials and other results. In a couple of articles published over the last two weeks, my co-authors and I deliver… Continue reading No trial stands alone
The Problem with Models
Chicago in plastic and balsa. If only animal models were as convincing as the one pictured above from the Museum of Science and Industry. The August 7 issue of Nature ran a fascinating feature on how many scientists are reassessing the value of animal models used in neurodegenerative preclinical research (“Standard Model,” by Jim Schnabel).… Continue reading The Problem with Models
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… Continue reading STAIRing at Method in Preclinical Studies