Trial publication records
March 22, 2016
Funding Bodies give money to institutions to undertake research to ultimately improve patient care. And to achieve this aim the registration and timely publication of trial results is obviously an important step. Yet, we have known for sometime that this is simply not happening: on average about half of all trials go unpublished.
As an example, a recent study of US academic medical centers with trials registered on ClinicalTrials.gov reported that results were made available for only 2/3rds of the 4347 interventional clinical trials done across 51 academic medical centers; just over one third (36%) managed to publish their results within 24 months of study completion. The authors concluded that performance is poor and highly variable: the very best performing centre could only publish 55% of their study results with 24 months of trial completion.
We audited trials done at the University of Oxford to better understand its publication record and performance in achieving publication within 12 months of trial completion. Why 12 months? Because both the EU (in 2014) and the FDA (in 2007) required clinical trials to post results within 12 months of completion.
To do the the audit we used a four step process: Create, Populate, Verify and Assess.
Step 1: Create an inventory of clinical trials using a hierarchy of sources to verify the institution’s records, including the EU Clinical Trials Register; International Clinical Trials Registry Platform; and the International Standard Randomised Controlled Trial Number.
Step 2: Populate the inventory and assess the registration using the major trial registries
Step 3: Verify the validity of the inventory
Step 4: Assess the publication status through multiple searches including PubMed Trials.Gov and contact PIs.
From our 4 step process we found 286 trials of which 98.6% were registered: of these just over half (56%) were published and of these, half were published within 12 months (36/147, 25%).
It is worth pointing out though, that there seems to be systemic and structural problems with getting work published in a timely manner. You would think with trials this wouldn’t be the case, but two previous studies estimate publication rates at 12 months vary from a miserly 13% to 22%; and a 2014 systematic review – including 22 studies – estimated publication rates were on average only about 54% after 24 months after trials had completed [8 9]
Audit of trial publication by an institution is therefore practical and possible. We now hope – well I do – that the findings can be used to drive up performance; but also can be used to form the impetus for other institutions to do their own audits. And if this doesn’t occur, then funders should seriously consider making it a mandatory requirement of their decision to fund or not future trials.
And to drive up performance the BRC and BRU’s, who oversee the undertaking of many of the trials in Oxford, but not all, have come up with some straight forward recommendations to improve the current situation. I think you should consider them too.
Organisational recommendations following the audit findings.
It’s time all clinical trial results are reported.
Patients, researchers, pharmacists, doctors and regulators everywhere will benefit from publication of clinical trial results. Wherever you are in the world please sign the petition:
Cite as Heneghan C (2016): Why institutions should audit their trial publication record CEBMJ https://www.cebm.net/institutions-audit-trial-publication-record/ DOI: 10.13140/RG.2.1.3138.4729