Contribution of research networks to a clinical trial of antidepressants in people with dementia

Abstract

Background.

The Mental Health Research Network and Dementia and Neurodegenerative Diseases Research Network were established in the UK to increase research capacity and activity; the former in mental health generally, and the latter specifically in neurodegenerative disorders including dementia. Little evidence exists on the impact of these networks on research in mental health of older people.

Aims

To examine research network support to a multi-centre randomised controlled trial of antidepressants in people with depression superimposed on dementia.

Method

Qualitative questionnaires were completed by principal investigators, trial-funded research workers and clinical study officers (CSOs) of the research networks.

Results

Research network contribution was much valued by principal investigators and the nine research teams. CSOs boosted the recruitment campaign in a challenging environment and enhanced assessment processes. Some problems with consistency and staff turnover were raised.

Conclusion

Research network input can make an appreciable difference to the process and outcome of a multi-centre clinical trial.

Keywords:

• research networks
• trial management
• mental health
• recruitment
• depression, dementia

Acknowledgements

The authors would like to thank all respondents for their contribution to the study. Joanne Ashcroft (deputy assistant director, MHRN) gave valued advice on the questionnaire design and draft paper. Views expressed are the authors' own rather than those of the research networks.

Declaration of Interest: HTA-SADD was funded by the UK Department of Health, but the study reported here received no additional funding.

Conflict of Interest Statement: N.M. was the trial manager of HTA-SADD. He led the design of the study reported here, performed data collection and analysis, and wrote the paper. L.D. was the grant-funded research worker in Liverpool and latterly held a managerial post in MHRN North West hub. She helped to design the questionnaires and analyse the data from CSO and PIs. She was also invited to complete the grant-funded research worker questionnaire, but did not have access to the data from others in this role. S.B. was the chief investigator of HTA-SADD. He supervised the design and conduct of the study and commented on the draft paper. He was invited to complete the principal investigator questionnaire as local investigator of the South London site, but did not have access to the data from any other participants.