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Discontinuation and non-publication of surgical randomised controlled trials: observational study

BMJ 2014; 349 doi: https://doi.org/10.1136/bmj.g6870 (Published 09 December 2014) Cite this as: BMJ 2014;349:g6870

Surgical knives under microscope: more not less

The critical problem facing surgical trials is that not enough trials are being attempted. In oncology, high quality evidence from a randomised controlled trial is mandatory before any new drug is licensed. All new drugs need to jump through many regulatory hoops before they can be licensed and used clinically. Even if licensed, funding is not always available for new drugs. (eg Cabazitaxel in prostate cancer)[2].

On the other hand, surgical procedures and non-drug interventions are widely adopted after early positive results from non-randomised case series and then very few attempts are made to evaluate their clinical and cost effectiveness with some notable exceptions. (eg Robot assisted prostate surgery).[3][4].

As the authors point out ‘poor recruitment’ is a major cause of failure to complete surgical trials.[5]. The answer to the problem is to encourage the ‘clinical trial cheerleaders’ in each hospital and minimise administrative hurdles for doing trials. It is important to ensure that the changes to research governance frameworks, proposed by the authors, help and does not hinder further clinical surgical trials.

References
1 Trotta F, Leufkens HGM, Schellens JHM, et al. Evaluation of Oncology Drugs at the European Medicines Agency and US Food and Drug Administration: When Differences Have an Impact on Clinical Practice. J Clin Oncol 2011;29:2266–72. doi:10.1200/JCO.2010.34.1248

2 Cabazitaxel for hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen | Guidance and guidelines | NICE. http://www.nice.org.uk/guidance/TA255 (accessed 11 Jan2015).

3 Finkelstein J, Eckersberger E, Sadri H, et al. Open Versus Laparoscopic Versus Robot-Assisted Laparoscopic Prostatectomy: The European and US Experience. Rev Urol 2010;12:35–43.

4 Davison BJ, Matthew A, Gardner AM. Prospective comparison of the impact of robotic-assisted laparoscopic radical prostatectomy versus open radical prostatectomy on health-related quality of life and decision regret. Can Urol Assoc J J Assoc Urol Can 2014;8:E68–72. doi:10.5489/cuaj.480

5 Chapman SJ, Shelton B, Mahmood H, et al. Discontinuation and non-publication of surgical randomised controlled trials: observational study. BMJ 2014;349:g6870–g6870. doi:10.1136/bmj.g6870

Competing interests: I am a member of NHS England Specialised Urology Clinical Reference Group (CRG) and NHS England-Cancer Drugs Fund (CDF) panel and NHS England is seeking to rationalise use of Robotic surgery and Cabazitaxel chemotherapy. The views expressed here are my personal opinion and do not reflect in anyway the views of any other organisation.

11 January 2015
Santhanam Sundar
Consultant Oncologist
Nottingham University Hospital NHS trust
Nottingham