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Original article
High hospital research participation and improved colorectal cancer survival outcomes: a population-based study
  1. Amy Downing1,2,
  2. Eva JA Morris1,2,3,
  3. Neil Corrigan4,
  4. David Sebag-Montefiore1,2,5,
  5. Paul J Finan5,6,
  6. James D Thomas6,
  7. Michael Chapman7,
  8. Russell Hamilton8,
  9. Helen Campbell8,9,
  10. David Cameron10,11,
  11. Richard Kaplan10,12,
  12. Mahesh Parmar12,
  13. Richard Stephens13,
  14. Matt Seymour1,2,5,10,
  15. Walter Gregory4,
  16. Peter Selby1,2,5
  1. 1Leeds Institute of Cancer and Pathology, University of Leeds, St James's University Hospital, Leeds, UK
  2. 2Cancer Research UK Centre, University of Leeds, St James's University Hospital, Leeds, UK
  3. 3MRC Bioinformatics Centre, Leeds, UK
  4. 4Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK
  5. 5Leeds Teaching Hospitals NHS Trust, Leeds, UK
  6. 6National Cancer Intelligence Network, London, UK
  7. 7Cancer Research UK, London, UK
  8. 8Department of Health, Research and Development, London, UK
  9. 9Clinical Research Facilities, and Cancer Research, University of Exeter Medical School, Exeter, UK
  10. 10NIHR Cancer Research Network, Leeds, UK
  11. 11Edinburgh Cancer Research Centre, University of Edinburgh, Western General Hospital, Edinburgh, UK
  12. 12MRC Clinical Trials Unit at University College London, London, UK
  13. 13NCRI Consumer Liaison Group, NIHR Cancer Research Network, Leeds, UK
  1. Correspondence to Professor Peter Selby, Cancer Research Building, St James's University Hospital, Leeds LS9 7TF, UK; p.j.selby{at}leeds.ac.uk

Abstract

Objective In 2001, the National Institute for Health Research Cancer Research Network (NCRN) was established, leading to a rapid increase in clinical research activity across the English NHS. Using colorectal cancer (CRC) as an example, we test the hypothesis that high, sustained hospital-level participation in interventional clinical trials improves outcomes for all patients with CRC managed in those research-intensive hospitals.

Design Data for patients diagnosed with CRC in England in 2001–2008 (n=209 968) were linked with data on accrual to NCRN CRC studies (n=30 998). Hospital Trusts were categorised by the proportion of patients accrued to interventional studies annually. Multivariable models investigated the relationship between 30-day postoperative mortality and 5-year survival and the level and duration of study participation.

Results Most of the Trusts achieving high participation were district general hospitals and the effects were not limited to cancer ‘centres of excellence’, although such centres do make substantial contributions. Patients treated in Trusts with high research participation (≥16%) in their year of diagnosis had lower postoperative mortality (p<0.001) and improved survival (p<0.001) after adjustment for casemix and hospital-level variables. The effects increased with sustained research participation, with a reduction in postoperative mortality of 1.5% (6.5%–5%, p<2.2×10−6) and an improvement in survival (p<10−19; 5-year difference: 3.8% (41.0%–44.8%)) comparing high participation for ≥4 years with 0 years.

Conclusions There is a strong independent association between survival and participation in interventional clinical studies for all patients with CRC treated in the hospital study participants. Improvement precedes and increases with the level and years of sustained participation.

  • COLORECTAL CANCER
  • HEALTH SERVICE RESEARCH
  • CLINICAL TRIALS

This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

https://doi.org/10.1136/gutjnl-2015-311308

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    Footnotes

    • AD and EJAM are joint first authors.

    • MS, WG and PS contributed equally as senior authors.

    • Contributors All authors contributed to the programme of work which led to this manuscript and all contributed to, saw and approved the final manuscript. AD, EJAM, NC, MS, WG and PS contributed to the analysis. AD, EJAM, RS, MS, WG and PS constituted the writing group who worked on the detailed preparation of the manuscript which was then modified and confirmed by the wider authorship.

    • Funding While undertaking this work EJAM and AD were supported by the CRUK Bobby Moore Fund (C23434/A9805), and EJAM by the Leeds Medical Research Council Medical Bioinformatics Centre (MR/L01629X/1).

    • Competing interests RK has received research funding from Bayer, Astra Zeneca and Glaxo Smith Kline (paid to the University of Leeds) and has been paid for a consulting or advisory role by Celldex Therapeutics. MS has received research funding from IntegraGen (paid to the University of Leeds). WG has been paid for a consulting or advisory role by Celgene and honoraria by Celgene.

    • Ethics approval East of Scotland Research Ethics Committee.

    • Provenance and peer review Not commissioned; externally peer reviewed.