Co-enrolment of Participants into Multiple Cancer Trials: Benefits and Challenges.
Opportunities to enter patients into more than one clinical trial are not routinely considered in cancer research and experiences with co-enrolment are rarely reported. Potential benefits of allowing appropriate co-enrolment have been identified in other settings but there is a lack of evidence base or guidance to inform these decisions in oncology. Here, we discuss the benefits and challenges associated with co-enrolment based on experiences in the Add-Aspirin trial - a large, multicentre trial recruiting across a number of tumour types, where opportunities to co-enrol patients have been proactively explored and managed. The potential benefits of co-enrolment include: improving recruitment feasibility; increased opportunities for patients to participate in trials; and collection of robust data on combinations of interventions, which will ensure the ongoing relevance of individual trials and provide more cohesive evidence to guide the management of future patients. There are a number of perceived barriers to co-enrolment in terms of scientific, safety and ethical issues, which warrant consideration on a trial-by-trial basis. In many cases, any potential effect on the results of the trials will be negligible - limited by a number of factors, including the overlap in trial cohorts. Participant representatives stress the importance of autonomy to decide about trial enrolment, providing a compelling argument for offering co-enrolment where there are multiple trials that are relevant to a patient and no concerns regarding safety or the integrity of the trials. A number of measures are proposed for managing and monitoring co-enrolment. Ensuring acceptability to (potential) participants is paramount. Opportunities to enter patients into more than one cancer trial should be considered more routinely. Where planned and managed appropriately, co-enrolment can offer a number of benefits in terms of both scientific value and efficiency of study conduct, and will increase the opportunities for patients to participate in, and benefit from, clinical research.
MRC Clinical Trials Unit at UCL, London, UK. Electronic address: f.cafferty@ucl.ac.uk.
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Cafferty
MRC Clinical Trials Unit at UCL, London, UK.
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Coyle
MRC Clinical Trials Unit at UCL, London, UK.
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Rowley
NCRI Consumer Liaison Group, London, UK.
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Berkman
Independent Cancer Patient Voices, London, UK.
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MacKensie
MRC Clinical Trials Unit at UCL, London, UK.
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Langley
D000328:Adult; D035843:Biomedical Research / Q000379:methods*; D002986:Clinical Trials as Topic / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D009369:Neoplasms / Q000628:therapy*; D018579:Patient Selection
Adjuvant; aspirin; cancer; co-enrolment; randomised controlled trial