Intended for healthcare professionals

Rapid response to:

Editorials

Clinical trials: what a waste

BMJ 2014; 349 doi: https://doi.org/10.1136/bmj.g7089 (Published 10 December 2014) Cite this as: BMJ 2014;349:g7089

Rapid Response:

Re: Clinical trials: what a waste

It is with great interest that I read Mr Ioannidis’ article entitled “Clinical trials: what a waste” (1) and indeed all of the follow up responses, where some interesting very interesting points were raised.

As a current core surgical trainee in the final year of my core training programme the need to get involved in randomised controlled trials as an integral part of training and development is becoming ever more apparent. In my current Plastic Surgical post I can say without doubt that this speciality is one which is taking the call to make the evidence by which they practice much more robust, very seriously.

Clinical trials are the foundation for evidence based medicine and therefore need to remain the future of all surgical specialities, and whether these look at innovative ideas or re-assesses old techniques is really irrelevant, as long as they are being conducted in the appropriate manner.
The NHS pledged £1 billion per annum until 2016 to support multi-centre research trials and as part of this The British Association or Plastic, Reconstructive and Aesthetic Surgery (BAPRAS) and The British Society for Surgery of the Hand (BSSH) have collaborated to develop the Reconstructive Surgery Trials Network (RSTN) (2). The RSTN is the UK clinical trials and collaborative research network for plastic surgery and hand surgery developed with an aim of encouraging a developing culture of clinical trials, multicentre national collaboration and involvement of clinicians at all levels (it is open to everyone from medical students to Consultants to pitch and pursue trial ideas). The whole aim of the RSTN is to then help these clinicians get their projects off the ground, running and with an aligned vision among the researchers and the related surgical community, so as to avoid as many of the problems with RCTs as mentioned in the original article, specifically to help against the problem of trials not coming to fruition.

Interestingly many of the trials commenced by the RSTN are looking at old practices to determine whether or not what we do (which surgeons have been doing for many years in many cases) actually has any good evidence behind it. For example the NINJA trial, which is looking at the benefits of replacing or not replacing the nail plate in nailbed repairs (3). Therefore, in response to Dr Bennett’s (4) response I think that Plastic Surgery is just one of the specialities and I’m sure that there are many more out there too, taking responsibility for their practices, to ensure they continue to provide the best possible care for their patients, with robust, well researched evidence to back it up.
I completely agree with Mr McCulloch (5), who urged in his response for the surgical community to do more to nurture, support and develop the preliminary studies which are needed in order for RCT’s to do better and the RSTN is just one way of surgical specialities doing this.

With this highlighted, however, I do think that we should also be urging our current UK medical schools to be building the ideas of RCTs, how to design and execute one in some way into the undergraduate Medical School curriculum. I received a fantastic education from both of my Medical Schools (St. Andrews and Manchester), however, I can’t help but feel now that the practical aspects of developing a RCT, assessing which ones were good, which are needed and assessing all the evidence they provide was somewhat left out. Perhaps encompassing this early into the curriculum would mean a better understanding and application later on in a doctor’s career, which should in theory help prevent all the things Professor Ioannidis (1) quite rightly stated exist: the excess of unfinished, unused, unpublished, even irrelevant research. It would perhaps give those embarking on attempting to set up an RCT a better idea of what it is actually like, with all the many difficulties they entail, thus making them better equipped to do so. With how things are now moving forward in clinical medicine and surgery, surely understanding trials and how they feed and form the basis for the medicine we practice is something equally as important as the actual medicine we practice and, therefore, should be treated by the undergraduate medical curriculum as such?

Whether medical schools start to include this in their basic curriculum or not and whether it would help or not, can be debated. Although developing the same standards and with wide poly-speciality variation in well designed RCT’s in surgery has perhaps a long way to go before it can be considered comparable to those in a medical speciality, we are moving forward in the right direction, with good pace and enthusiasm.

1) Ioannidis JPA. Clinical trials: what a waste. BMJ. 2014;349:g7089
2) http://reconstructivesurgerytrials.net/
3) http://reconstructivesurgerytrials.net/clinical-trials/ninja/
4) Bennett DB. Re: Clinical trials: what a waste. http://www.bmj.com/content/349/bmj.g7089/rr-3
5) McCulloch PG. Re: Clinical trials: what a waste. http://www.bmj.com/content/349/bmj.g7089/rr-5

Competing interests: No competing interests

08 March 2015
Sarah-Jayne Edmondson
Core Surgical Trainee Year 2
Royal Free Hospital NHS Foundation Trust, London.