What is this about?
“All trials registered, all results reported.” The AllTrials campaign is aiming towards publication of all of the results, from all clinical trials, on all treatments used. Their goal is to make this a reality for present, but also for past and future clinical trials. They launched in 2013, as an initiative of Ben Goldacre, BMJ, Centre for Evidence-based Medicine, Cochrane Collaboration, James Lind Initiative, PLOS and Sense about Science.
- Goldacre B. Are clinical trial data shared sufficiently today? No. BMJ.2013; 347 :f1880
Why is this important?
In evidence-based medicine (EBM), results from all of the studies on a particular treatment are collected and combined to make a single and robust conclusion that will impact clinical practice. To do this, researchers can only use evidence that is available to them. Research has shown that half of clinical trials end up never being published, and even more so if they have negative results about a treatment. This means that evidence informing EBM usually is distorted in favour of different treatments, which may not have the same effect in a real population, and some serious adverse events become discovered too late to prevent their impact. That is why it is important that all of the results are published, and not necessarily in journals.
For whom is this important?
What are the best practices?
Since 2008, the American Food and Drug Administration (FDA) has required that results of all trials have to be posted within one year of their completion. This legislation, like others, does not work retroactively, which means that every treatment tested before 2008 does not have to have published results. Also, since the legislation came into action, no studies have been fined for noncompliance, and research has shown that 80% of clinical trials do not comply. Major clinical trial registries (clinicaltrials.gov, eudraCT), have independent trials trackers, led by Data Lab from Oxford University. They collect a list of trials that have ended and whether or not they published their results. The Data Lab also collaborated with Goldacre on Open Trials. Its aim is to collect everything related to clinical trials in one place, including their registration, data, reports, publications and researchers.
- Prayle AP, Hurley MN, Smyth AR. Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: cross sectional study. BMJ. 2012;344:d7373. http://www.bmj.com/content/344/bmj.d7373
- Anderson ML, Chiswell K, Peterson ED, Tasneem A, Topping J, Califf RM. Compliance with results reporting at ClinicalTrials.gov. N Engl J Med. 2015;372(11):1031–1039. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4508873/ ]]
The Embassy Editorial team, The Embassy editorial team, Ružica Tokalić, Iris Lechner, Natalie Evans, Philipp Hoevel, Anna Catharina Armond, Benjamin Benzon contributed to this theme. Latest contribution was Mar 25, 2021