What can we learn from oncology surgical trials?

Abstract

Conducting high-quality prospective clinical trials in surgical oncology remains a challenge, and many seemingly well-designed trials lack this high quality because of inadequate recruitment accrual, lack of clinician interest, or evolution of treatment strategy during the many years over which such trials are conducted. In this Perspectives we examine some of the failures in published surgical oncology trials and discuss why they failed, and we make a critical assessment of the established prospective trial methodology in oncological practice (that is, phase 0, I, II, III and IV trials, and large prospective comparative audits) and how these methods might be used more effectively in future evaluation of cancer-surgery practice.

Impact of mesenteric defect closure technique on complications after gastric bypass

“…Any adaption to an established surgical procedure should preferably be assessed as part of a clinical trial [ 20 ]. Unfortunately, most adaptions have never been evaluated and scientific support for these is therefore weak [ 21 , 22 ]. Bearing this in mind, some adaptions have reached wide acceptance within the Swedish surgical community and have possibly contributed to the reduction in the number of complications associated with closure of mesenteric defects with running, non-absorbable sutures.…”

European Society of Surgical Oncology's strategy for clinical research: Paving the way for a culture of research in cancer surgery

“…There is great need for research to demonstrate and establish the impact of surgery in an oncological field that is mainly driven by advances in cancer biology and immune-oncology, yet, only 1% of cancer patients is recruited into surgical oncology trials in Europe. Conducting research in surgical oncology has always been challenging due to a number of surgery-related reasons further detailed below [3].…”

“…Recently, the CONSORT checklist was reduced from 25 items to 10, hoping to improve compliance [5]. Still, the quality of reporting in the surgical literature is poor, and feasible alternative methodologies somewhere on the spectrum between retrospective reports and RCTs are underused, especially in phases II and IV [3]. The role of surgical journals here is crucial.…”

Commentary: how will interventional oncology navigate the “valleys of death” for new medical devices?

“…Clinicians in the disciplines of surgical oncology, radiation oncology and interventional oncology (IO) recognize that the current challenge for these specialties is to generate high-level clinical evidence for loco-regional treatments to define the benefits for patients. 2, 3,5 There is a need for standards that are proportionate, reasonable and pragmatic, and for clinical studies with realistic and patient-centred endpoints. Consistent with a recent article on the licensing of new drugs, 1 we argue that, to generate convincing evidence of clinical efficacy and safety to regulators, the collective coherence of the entire data package is often more important than the primary endpoint of one clinical trial.…”