Clinical Research Editorial
The ESSO Clinical Research Committee: Leading a New Direction
Editorial by Serge Evrard, Chair of the CRC
Research in surgery has a bad reputation. Only 8% of the phase 3 trials are surgical studies1. Many of them are of poor quality with only 55% adhering to the CONSORT criteria2. Among the 395 surgical trials recorded in ClinicalTrials.gov in 2013, one out of five were discontinued early, one out of three completed trials remain unpublished, and investigators of unpublished studies were frequently not contactable3. And this goes without mentioning critical editorials saying that surgical research is “a waste”4, a “comic opera “5, “as much as half of the research surgeons undertake is misconceived”5.
During the ESSO 34 congress in Liverpool, the ESSO board decided to take action. Since its creation, ESSO has been involved in teaching activities, congress organisations, and oncopolicy but never in clinical research. For most surgeons, it is a requirement to complete one’s professional experience but remains to be particularly difficult to undertake. While completing the chapter of the ESSO textbook on Clinical Research methodology (to be released in 2016), we had the opportunity to analyse all the difficulties of clinical research in surgery and to discuss some proposals and initiatives to address these. Excellence in research is a duty of surgeons to their patients. It is the only way we will win the battle against cancer. And because ESSO embodies excellence in surgical oncology, it has decided to embark on this new path. Thus, the ESSO Clinical Research Committee (CRC) was established to carry out this important task, surgical research.
Randomised trial is considered as the gold standard of evidence-based medicine and educating surgeons on this is perceived as the only manner to unlock the potential of research in surgery6. But it is not always feasible to randomise surgical procedures the way drugs in oncology trials are randomized. There is a major risk to rely on scientific data based on studies without the appropriate methodological design and quality assurance.Considering only randomized controlled trials as the reliable source of evidence has led to the failure of surgical oncology to position itself on the field of clinical research. To be pragmatic, we have to consider alternative research strategies that are feasible but with measures of quality assurance.
Two main strategies are proposed by the Clinical Research Committee (CRC). One is to develop a framework for quality assurance in surgical trials and another is to utilize other appropriate research methodologies to develop prospective, feasible and high quality surgical research7-9. It is time to try to fill in the gap between the ideal clinical setting and the real world and to reduce the amount of unsuccessful clinical trials4.
Hopefully, clinical research will be a passion among surgeons. We have within our network numerous young, enthusiastic surgeons willing to push the boundaries to deliver excellent research to improve patient care. In this exciting journey, we will not be alone. Two of the main world operators in clinical research are working with us, the European Organisation for Research and Treatment of Cancer (EORTC) and the Japan Clinical Oncology Group (JCOG). Together we will build a comprehensive surgical platform with all the necessary facilities to produce a force against resignation. Although the challenge will be difficult, but we must act urgently: only 1% of the patients operated on for a tumour in Europe are included in a trial. Together with the Clinical Research Committee, I willingly take on the commitment to mobilise all the ESSO forces and to invite YOU to be part of this change.
- Barkun JS, Aronson JK, Feldman LS, et al.: Evaluation and stages of surgical innovations. Lancet 374:1089-1096, 2009
- Adie S, Harris IA, Naylor JM, et al.: CONSORT compliance in surgical randomized trials: are we there yet? A systematic review. Ann Surg 258:872-878, 2013
- Chapman SJ, Shelton B, Mahmood H, et al.: Discontinuation and non-publication of surgical randomised controlled trials: observational study. BMJ 349:g6870, 2014
- Ioannidis JP: Clinical trials: what a waste. BMJ 349:g7089, 2014
- Horton R: Surgical research or comic opera: questions, but few answers. Lancet 347:984-985, 1996
- Potter S, Mills N, Cawthorn SJ, et al.: Time to be BRAVE: is educating surgeons the key to unlocking the potential of randomised clinical trials in surgery? A qualitative study. Trials 15:80, 2014
- Benson K, Hartz AJ: A comparison of observational studies and randomized, controlled trials. N Engl J Med 342:1878-1886, 2000
- Concato J, Shah N, Horwitz RI: Randomized, controlled trials, observational studies, and the hierarchy of research designs. N Engl J Med 342:1887-1892, 2000
- Neuman HB, Greenberg CC: Comparative effectiveness research: opportunities in surgical oncology. Semin Radiat Oncol 24:43-48, 2014