I have mentioned Richard Lehman’s weekly journal review here before. This week’s edition starts with a critique of a trial published in the PNEJM, funded by a company that makes a new antiviral, the results show a reduction in virus shedding in adults with Herpes randomized to get the new drug. Richard Lehman asks
Does this reduction in shedding actually have any clinical significance? At what point should the FDA release it for use on the general population? What should the end points be, and what should be the duration of the next trial? I think these issues should be a matter of public debate, and not a matter for AiCuris [the manufacturer] to decide. Same with all new drugs. It is we who will be using them, we who will pay for them, and we who stand to be harmed by them.
Exactly. There are too many trials with surrogate end-points of unknown or dubious clinical significance, this new trial publication doesn’t give any evidence that the patients were actually better off with the new drug.
Which leads me to the final two papers in the Lancet series on improving quality and reducing waste in research.
Glasziou P, Altman DG, Bossuyt P, Boutron I, Clarke M, Julious S, Michie S, Moher D, Wager E: Reducing waste from incomplete or unusable reports of biomedical research. The Lancet 2014, 383(9913):267-276.
Chan A-W, Song F, Vickers A, Jefferson T, Dickersin K, Gøtzsche PC, Krumholz HM, Ghersi D, van der Worp HB: Increasing value and reducing waste: Addressing inaccessible research. The Lancet 2014, 383(9913):257-266.
Both of them again have suggestions for improvement, and the article by Paul Glasziou, in particular I find very insightful; journal editors should all take note! (and reviewers like me.)