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In his editorial, Charles Warlow suggested that the MRC provide
incentives such as a research nurse to collaborators in its multicentre
trials. Such incentives need to be effective if they are to help maximise
its investment in large trials. However, there is little high quality
evidence to support the use of specific interventions to improve
recruitment. Ross and colleagues undertook a systematic review of 78
papers reporting barriers to recruitment of clinicians and patients to
randomised controlled trials (1). Among several testable hypotheses, they
proposed that provision of dedicated research staff to support clinical
staff and patients may be an effective strategy for enhancing recruitment.
The International Neonatal Immunotherapy Study (INIS) is a MRC funded
multicentre trial in which 56 neonatal units are currently participating
in the UK and Australia. Up to 150 units are expected to participate
worldwide and the planned sample size is 5,000 (2). Currently each unit
is supported with an average of about 1.5 hours of research nurse time per
week. In view of the adverse budgetary and scientific implications of
slower than expected recruitment, it seems appropriate to test the
hypothesis that increasing research nurse time in cluster randomised
studies enhances recruitment in trials such as INIS. And if it does
enhance recruitment, how much funded time is optimal before additional
improvements are offset by rapidly increasing costs?
sincerely
William Tarnow-Mordi, professor, neonatal medicine, University of
Sydney, Westmead Hospital and The Children's Hospital at Westmead, NSW
2145, Australia.
Anne Cust, INIS trial co-ordinator, NHMRC Clinical Trials Centre,
University of Sydney, NSW.
Peter Brocklehurst, director, Simon Gates, trials researcher/
statistician, National Perinatal Epidemiology Unit, Health Sciences
Institute, Old Road, Headington, Oxford.
References:
1. Ross S, Grant A, Counsell C, Gillespie W, Russell I, Prescott R.
Barriers to participation in randomised controlled trials: a systematic
review. J Clin Epidemiol. 1999 Dec;52(12):1143-56.
2. International Neonatal Immunotherapy Study Protocol. National Perinatal
Epidemiology Unit. www.npeu.ox.ac.uk/INIS.htm accessed 18 July 2003
Competing interests:
All signatories are investigators or members of the trial management team of the International Neonatal Immunotherapy Study.
Competing interests:
No competing interests
13 August 2003
William O Tarnow-Mordi
professor of neonatology
Peter Brocklehurst, Anne Cust, and Simon Gates,
University of Sydney, Westmead Hospital, NSW 2145, Australia
Clinical trials for tomorrow funded by the MRC
In his editorial, Charles Warlow suggested that the MRC provide
incentives such as a research nurse to collaborators in its multicentre
trials. Such incentives need to be effective if they are to help maximise
its investment in large trials. However, there is little high quality
evidence to support the use of specific interventions to improve
recruitment. Ross and colleagues undertook a systematic review of 78
papers reporting barriers to recruitment of clinicians and patients to
randomised controlled trials (1). Among several testable hypotheses, they
proposed that provision of dedicated research staff to support clinical
staff and patients may be an effective strategy for enhancing recruitment.
The International Neonatal Immunotherapy Study (INIS) is a MRC funded
multicentre trial in which 56 neonatal units are currently participating
in the UK and Australia. Up to 150 units are expected to participate
worldwide and the planned sample size is 5,000 (2). Currently each unit
is supported with an average of about 1.5 hours of research nurse time per
week. In view of the adverse budgetary and scientific implications of
slower than expected recruitment, it seems appropriate to test the
hypothesis that increasing research nurse time in cluster randomised
studies enhances recruitment in trials such as INIS. And if it does
enhance recruitment, how much funded time is optimal before additional
improvements are offset by rapidly increasing costs?
sincerely
William Tarnow-Mordi, professor, neonatal medicine, University of
Sydney, Westmead Hospital and The Children's Hospital at Westmead, NSW
2145, Australia.
Anne Cust, INIS trial co-ordinator, NHMRC Clinical Trials Centre,
University of Sydney, NSW.
Peter Brocklehurst, director, Simon Gates, trials researcher/
statistician, National Perinatal Epidemiology Unit, Health Sciences
Institute, Old Road, Headington, Oxford.
References:
1. Ross S, Grant A, Counsell C, Gillespie W, Russell I, Prescott R.
Barriers to participation in randomised controlled trials: a systematic
review. J Clin Epidemiol. 1999 Dec;52(12):1143-56.
2. International Neonatal Immunotherapy Study Protocol. National Perinatal
Epidemiology Unit. www.npeu.ox.ac.uk/INIS.htm accessed 18 July 2003
Competing interests:
All signatories are investigators or members of the trial management team of the International Neonatal Immunotherapy Study.
Competing interests: No competing interests