The task set before clinical investigators is not easy. They are supposed to answer pressing scientific questions, using very few resources, and exposing patient-subjects to as little risk as possible. In other words, we expect them to be rigorous scientists, stewards of the medical research enterprise, and guardians of their patients’ interests all at the… Continue reading Predicting Risk, Benefit, and Success in Research
Author: Spencer Phillips Hey
Nope– It’s Still Not Ethical
Last year, Jonathan and I published a critique of unequal allocation ratios in late-phase trials. In these trials, patient-subjects are randomly allocated among the treatment arms in unequal proportions, such as 2:1 or 3:1, rather than the traditional equal (1:1) proportion. Strangely, despite introducing an additional burden (i.e., requiring larger sample sizes) the practice of unequal allocation… Continue reading Nope– It’s Still Not Ethical
The Landscape of Early Phase Research
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
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
How Many Negative Trials Do We Need?
There is a growing concern in the clinical research community about the number of negative phase 3 trials. Given that phase 3 trials are incredibly expensive to run, and involve hundreds or sometimes thousands of patient-subjects, many researchers are now calling for more rigorous phase 2 trials, which are more predictive of a phase 3… Continue reading How Many Negative Trials Do We Need?