BMJ research chief: How can we get to zero unregistered clinical trials?
What would it take to make unregistered or retrospectively registered clinical trials a thing of the past? In an opinion piece run by the BMJ in February 2017, Elizabeth Loder, its head of research, proposed treating unregistered trials as the research equivalent of medical ‘Never Events’, defined as “particularly shocking medical errors (such as wrong-site surgery) that should never occur.”
Some choice extracts from her piece:
“Timely registration is a requirement that some researchers and journals still do not take seriously. Unregistered and retrospectively registered trials continue to be published… Even the Committee on Publication Ethics takes a soft line on late trial registration…”
“[A] recent analysis of data from the largest trial registry, Clinicaltrials.gov, shows that about a third of trials from 2012 through 2014 were registered late…”
“[A]lmost nothing lends itself so well to protocols and procedures as the simple act of matching a registration number to an online record in a registry or including trial registration on a checklist of items to be completed before funding is dispensed or a trial is allowed to proceed.”
“Funders and ethical approval bodies might make full payment or final approval of trials contingent on prospective registration. Journal editors should continue to refuse to publish such studies and notify institutional or company authorities of the problem when possible. (…) Institutional discipline could take many forms, including additional oversight of subsequent research projects or requiring that such omissions be considered in decisions about academic promotion.”
Elizabeth Loder’s post can be found here. It contains numerous links to relevant related research, including a trial registration audit she was personally involved in.
BioMed Central in 2016 published an interesting piece defending their decision to continue publishing retrospectively registered trials.