Recommendations for Randomised Trials in Surgical Oncology

J C Glasbey; E L Magill; K Brock; S P Bach

doi:10.1016/j.clon.2017.10.002

Recommendations for Randomised Trials in Surgical Oncology

Clin Oncol (R Coll Radiol). 2017 Dec;29(12):799-810. doi: 10.1016/j.clon.2017.10.002. Epub 2017 Oct 31.

Authors

J C Glasbey¹, E L Magill², K Brock³, S P Bach⁴

Affiliations

¹ Academic Department of Surgery, University of Birmingham, Birmingham, UK; Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.
² Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.
³ Devices, Drugs, Diagnostics and Biomarkers (D3B), Cancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, UK.
⁴ Academic Department of Surgery, University of Birmingham, Birmingham, UK; Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK; Devices, Drugs, Diagnostics and Biomarkers (D3B), Cancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, UK. Electronic address: s.p.bach@bham.ac.uk.

PMID: 29097072
DOI: 10.1016/j.clon.2017.10.002

Abstract

Trials of surgical procedures in the treatment of malignant disease face a unique set of challenges. This review aimed to describe recommendations for the design, delivery and reporting of randomised trials in surgical oncology. A literature search was carried out without date limits to identify articles related to trial methodology research in surgery and surgical oncology. A narrative review was framed around two open National Institute of Health Research portfolio trials in colon and rectal cancer: the STAR-TREC trial (ISRCTN14240288) and the ROCCS trial (ISRCTN46330337). Twelve specific challenges were highlighted: standardisation of technique; pilot and feasibility studies; balancing treatments; the recruitment pathway; outcome measures; patient and public representation; trainee-led networks; randomisation; novel techniques and training; learning curves; blinding; follow-up. Evidence-based recommendations were made for the future design and conduct of surgical oncology trials. Better understanding of the challenges facing trials in the surgical treatment of cancer will accelerate high-quality evaluation and rapid adoption of innovation for the benefit of patient care.

Keywords: Colorectal cancer; oncology; patient and public representation; randomised trials; research methodology; surgery.

Publication types

Review

MeSH terms

Humans
Randomized Controlled Trials as Topic / methods*
Research Design
Surgical Oncology / standards*

Grants and funding

19393/CRUK_/Cancer Research UK/United Kingdom