International Clinical Trials Day is celebrated annually on the 20th May to mark the inaugural study from James Lind, who aboard The Salisbury in 1747 recorded the first ever clinical trial.
Lind observed that British fleet scurvy caused more deaths than in French and Spanish fleets combined. He hypothesized that citrus fruit, available on the French and Spanish fleets, was reducing their risk. On May 20, 1747, Lind took 12 British sailors and tested whether these fruit would alleviate their scurvy symptoms (conclusion– it did).
Over the last 270 years since the days of James Lind, clinical trials have progressed to an exciting place (for some of the most recent developments in clinical trials see the International Clinical Trials Methodology Conference/Society of Clinical Trials 2017 Conference Abstracts published via Trials).
Pushes for greater transparency and reproducibility have put a lot of emphasis on clinical trial reporting. We’ve seen some great milestones over the last 20 years but where is the field going next?
What’s ongoing?
Combining CONSORT, or other reporting guidelines, and machine learning/artificial intelligence is opening windows of opportunity for clinical trial publications. For example, published in BMC Medicine, Caroline Barnes and colleagues developed an online writing aid tool that combines CONSORT and its extensions to help authors when writing randomized controlled trial reports.
Pushes for greater transparency and reproducibility have put a lot of emphasis on clinical trial reporting
CONSORT is also being used within the peer review process, integrated into text mining software to automate some aspects of the peer review process and assess completeness of clinical trial reporting (a pilot to assess this software is currently underway). Other studies have shown that additional reviews based on reporting guidelines help improve manuscript quality.
A full outline from the CONSORT Group on what key stakeholders could do to support better trial reporting was also posted today to celebrate Clinical Trials Day, and can be found here. As I’m sure you’ll agree, these developments hold a lot of promise for the field.
Supporting a complete and transparent publication record for clinical trials is becoming more commonplace in the field, from registration, to study protocol and statistical analysis plan publications, primary results and secondary analysis, as well as research alongside clinical trials to help build an evidence base for how to run an efficient clinical trial (for more information see this Trial Forge paper in Trials).
With a single trial producing this plethora of publications, identifying all related articles has become increasingly difficult and has led to another of the major milestones in clinical trial reporting; linked clinical trials or ‘threaded publications’ (first coined by Doug Altman). Via the trial registration number (a unique identifier for any clinical trial), it’s now possible to link all publications across different publishers within the CrossRef metadata.
And what’s next?
Online publication and open science have helped establish an exciting landscape for publishing and reporting. We are looking forward to what the next years will bring for clinical trial reporting and can only begin to imagine what it will look like in another 270 years…
The reproducibility crisis has bought many of the issues with science to the forefront of our attentions, and with recent estimates that 85% of research is wasted there is a clear need for change. Many of the next steps for clinical trials will have these issues incorporated at their heart.
For clinical trial reporting, one of the next big things will involve data sharing. In January 2016, the International Committee of Medical Journal Editors (ICMJE) announced a proposal for sharing clinical trial data, calling for feedback from all stakeholders (similar to the trial registration call back in 2004 – Question 1 in the Clinical Trials Day Quiz). They were inundated with responses (including ours from Springer Nature) and over a year later we are still waiting for the next draft, indicating the complexity of the data sharing. I’m predicting the debate around how best to proceed will be pretty hot.
Online publication and open science have helped establish an exciting landscape for publishing and reporting. We are looking forward to what the next years will bring for clinical trial reporting and can only begin to imagine what it will look like in another 270 years…
Please comment below on what you think the next big reporting milestone will be for clinical trial reporting!
Comments