Authors' objectives:

To review UK guidelines regarding the use of financial incentives for healthcare professionals to become involved in clinical trials, and to survey perceptions and current practice.

Authors' results and conclusions: The evidence from the literature was limited and inconclusive. In UK guidelines, the issues around payments to clinicians or patients were implied rather than stated, usually linked to discussion of conflict of interest and disclosure of any such conflicts. Developments in NHS research governance had led to increased transparency in all payments for research participation and for payments to be made to NHS Trusts rather than individual clinicians. While reimbursement of costs incurred by research was strongly supported by the interviewees, payments to incentivise recruitment were not. A code of practice was suggested for payments in publicly funded trials,which was closely linked to the principles of Good Clinical Practice in research. Factors such as interest in the topic, scope for patient benefit and good communication were considered more important than payment. Interviews with the general public indicated low levels of awareness of the existence of payments to clinicians linked to patient recruitment in trials, and unanimous support for full disclosure. Interviews with managers in the pharmaceutical industry showed greater familiarity with payments for research involvement. GPs were seen as the only group for whom scope existed for individual payments. Concerns were expressed by the pharmaceutical companyinterviewees at the rising cost of research and unnecessary bureaucracy.

Authors' recommendations: The ethical stances outlined in Good Clinical Practice in research were widely endorsed by the three groups interviewed. These allow reasonable payments to clinicians, subject to disclosure of any possible conflicts of interest. The potential for incentivising clinicians to recruit was limited as any payments should be based on the cost of inputs and should not be made to individuals but to their hostorganisation. NHS professionals were concerned that payments could damage the quality of research and also considered full disclosure to patients as challenging. Patients and members of the public favoured full disclosure and payment of expenses to patientsinvolved in research. Pharmaceutical company interviewees viewed payment to the NHS for all research activities as normal and highly regulated. They complained that the prices charged were high and so variable that they required benchmarking. Considerable scope exists for compiling data on the factors that help and hinder the progress of clinical trials and also for experimenting with different incentives to encourage involvement in clinical research. Further research should focus on improved reporting of those organisational aspects of trials that are known to affect recruitment; retrospective analysis of the factors associated with different levels of recruitment to RCTs; prospective comparative research on trial recruitment; qualitative research on participants’ experiences of being involved in different kinds of trials, and proposals to include within trials experiments with payments methods.

Authors' methods: Review

Project Status: Completed

URL for project: http://www.hta.ac.uk/1439

Year Published: 2008

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: England, United Kingdom

Organisation Name: NIHR Health Technology Assessment programme

Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK

Contact Name: journals.library@nihr.ac.uk

Contact Email: journals.library@nihr.ac.uk

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