BMJ  2003;327:320-321 (9 August), doi:10.1136/bmj.327.7410.320

Paper

Rate limiting factors in recruitment of patients to clinical trials in cancer research: descriptive study

¹ Oncology Centre (Box 193), Addenbrooke's NHS Trust, Cambridge CB2 2QQ

Introduction

In 2004 the national cancer research network, established in 2001, will be evaluated on a performance target of increasing recruitment of patients into cancer clinical trials. The national average in 2000-1 was 3.5% of incident cancer cases and the target was set at 7.5%. Much may depend on this target being met as £11.5m of government funding is being invested annually to provide infrastrucuture to conduct clinical trials within 34 networks across England. The future of this funding is not secure. We audited patients' involvement in clinical trials from a cohort of new cancer cases managed within a single research network to identify obstacles to recruitment.

Participants, methods, and results

The West Anglia cancer research network, a first wave regional research network, was established in 2001. It functions in close collaboration with the service based network. It covers a population of 1.65 million, and about 8000 new cases are seen each year. Patients discussed at weekly multidisciplinary team meetings are reviewed for their potential entry into trials. A database is kept of all patients considered for any clinical trial.

The figure summarises patients' data collected from team meetings in the cancer centre and four of the seven network cancer units during 2002. Of 1411 patients reviewed, 267 (19%) eventually entered a trial (the overall recruitment rate for our network in 2002 was actually 10%). No trial was available for 561 (40%) patients, and 390 (28%) were immediately excluded as they failed entry criteria. Of the 460 patients considered potentially eligible for trial entry, only 19 (4%) were not approached at all, 88 (19%) declined to take part, and 59 (13%) of those prepared to consider doing so ultimately failed screening procedures for specific trials. Overall, entry criteria disqualified 449 (53%) of the 850 patients for whom a trial was available.

View larger version (32K): [in this window] [in a new window]   Outcome for patients reviewed for entry into clinical trials according to type of cancer (CRC=colorectal; Pr/Bl=prostate/bladder; GI=gastrointestinal). Where cancer type is not mentioned there were no relevant patients

 

Comment

The main reasons for cancer patients not entering a trial were lack of an available study and failure to meet entry criteria. The task of doubling numbers of patients in cancer clinical trials by 2004 would therefore be made easier if a wider range of pragmatic trials was available. There is growing pressure on cancer specialists to ensure an active rolling national trial programme for each tumour type. Even so, funding for clinical research is limited. Research expenditure in the United Kingdom is over £250m annually, of which 22% goes on research into treatment¹ and much of this is disproportionately channelled into "high profile" cancers such as breast, prostate, and leukaemia.² Rare cancers with poor prognosis are frequently overlooked.

We found that even when a trial was available eligibility criteria excluded over half of patients. It is a common criticism that the outcomes of trials for new treatments are superior to those subsequently encountered in standard clinical practice. Trials with broad entry criteria that better reflect everyday life will help with recruitment of patients³ and probably yield more meaningful results.

Several national trials were not open for accrual in our research network because of lack of available service support and treatment costs. Although trusts are duty bound to provide support, our local research and development budgets are insufficient to meet the needs, while commissioners are in no financial position to be prioritising research over service needs. The onus must be on funding bodies and principal investigators of new trials to ensure adequate resourcing from the outset.

Finally, of those patients who were approached to enter a trial, one in five declined. Little is known about the factors that influence men and women to take part in clinical trials.⁴ There is much scope to involve consumers more actively in clinical research and encourage a partnership approach to improving cancer care.

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We thank all nurses, clinicians, and other support staff of the West Anglia cancer research network involved in the conduct of cancer clinical trials. We especially thank those patients who agreed to take part in a trial.

Contributors: PC and JS were responsible for designing the study. JS analysed the data. PC interpreted the results, prepared the manuscript, and is guarantor. RH contributed to writing the report.

Funding: None.

Competing interests: None declared.

Ethical approval: All trials had local research ethics committee approval.

References

1. National Cancer Research Institute. Strategic analysis. An overview of cancer research in the UK directly funded by the NCRI partner organisations. London: NCRI, October 2002.
2. Kmietowicz Z. Research spending on cancers doesn't match their death rates. BMJ 2001;325: 920.[CrossRef]
3. Baum M. The ATAC (arimidex, tamoxifen, alone or in combination) adjuvant breast cancer trial in postmenopausal patients: factors influencing the success of patient recruitment. Eur J Cancer 2002;38: 1684-6.
4. Comis RL, Miller JD, Aldige CR, Krebs L, Stoval E. Public attitudes toward participation in cancer clinical trials. J Clin Oncol 2003;21: 830-5.[Abstract/Free Full Text]

(Accepted May 27, 2003)

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