The Royal College of Surgeons of England (RCS), a professional membership organisation and registered charity representing over 20,000 surgeons internationally has joined AllTrials.
On joining the campaign, the RCS, which exists to advance surgical standards and improve patient care, are keen to stress the urgency with which the community must improve clinical trial transparency around non-regulated interventions (treatments other than drugs and devices).
Writing in RCS BLOG, Professor Derek Alderson, Vice President, Royal College of Surgeons of England said:
Lack of regulation makes it easier for non-drug trials to slip under the radar. A third of completed surgical trials are not published and selective reporting of positive outcomes has been found to be prevalent in published surgical trials. If things are left to continue along these lines, our evidence base for surgical trials will be biased. This will likely lead to flawed treatment decisions, detrimentally affecting patient care and outcomes.
The College whole heartedly supports the AllTrials campaign, and has set out its views in a recent statement on clinical trials transparency. We expect all researchers conducting trials, including those supported by the College, to register the trial in a publicly accessible database; submit its full study report for publication; share anonymised participant-level trial datasets; and provide access to data if a trial is discontinued.
The College has been instrumental in establishing a UK-wide network of Surgical Trials Centres, and funds around 30 surgical trainees annually to participate in research through the RCS Research Fellowship scheme. Our continuing work to promote trials in surgery will be closely accompanied by our commitment to publication of surgical trial results, as we recognise that this is vital for trials to fulfil their potential to transform surgical care.
In the medical research community, we need to focus more attention on improving the transparency of non-drug trials, especially since EU law will not address this. At the RCS our aim is to instigate a culture change towards improving the transparency of surgical trials, and we urge others with influence over trials on surgical and other non-regulated interventions to do the same.
Read Professor Alderson’s full RCS BLOG post – Transparency needed in non-drug trials
- Chapman et al. 2014. Discontinuation and non-publication of surgical randomised controlled trials: observational study BMJ 2014;349:g6870
- Hannink et al. 2013. Comparison of registered and published primary outcomes in randomized clinical trials of surgical interventions. Ann Surg. 2013 May; 257(5):818-23