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Negative results in phase III trials of complex interventions: Cause for concern or just good science?

  • Mike J. Crawford (a1), Kirsten Barnicot (a1), Sue Patterson (a2) and Christian Gold (a3)

Summary

Not all interventions that show promise in exploratory trials will be supported in phase III studies. But the high failure rate in recent trials of complex mental health interventions is a concern. Proper consideration of trial processes and greater use of adaptive trial designs could ensure better use of available resources.

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Copyright

Corresponding author

Mike J. Crawford, Centre for Mental Health Imperial College London Du Cane Road, London W12 0NN, UK. Email: m.crawford@imperial.ac.uk

Footnotes

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See pp. 54–61, this issue.

Declaration of interest

None.

Footnotes

References

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3 Tyrer, P, Cooper, S, Salkovskis, P, Tyrer, H, Crawford, M, Byford, S, et al. Clinical and cost-effectiveness of cognitive behaviour therapy for health anxiety in medical patients: a multicentre randomised controlled trial. Lancet 2014; 383: 219–25.
4 Gold, C. Signal and noise in music therapy outcome studies. Nord J Music Ther 2014; 23: 97–8.
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6 Craig, P, Dieppe, P, Macintyre, S, Michie, S, Nazareth, I, Petticrew, M, Medical Research Council Guidance. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ 2008; 337: a1655.
7 Campbell, M, Fitzpatrick, R, Haines, A, Kinmonth, AL, Sandercock, P, Spiegelhalter, D, et al. Framework for design and evaluation of complex interventions to improve health. BMJ 2000; 321: 694–6.
8 Moore, GF, Audrey, S, Barker, M, Bond, L, Bonell, C, Hardeman, W, et al. Process evaluation of complex interventions: Medical Research Council guidance. BMJ 2015; 350: h1258.
9 Crawford, MJ, Weaver, T, Rutter, D, Sensky, T, Tyrer, P. Evaluating new treatments in psychiatry: the potential value of combining qualitative and quantitative research methods. Int Rev Psychiatry 2002; 14: 611.
10 Thornicroft, G, Farrelly, S, Szmukler, G, Birchwood, M, Waheed, W, Flach, C, et al. Clinical outcomes of joint crisis plans to reduce compulsory treatment for people with psychosis: a randomised controlled trial. Lancet 2013; 381: 1634–41.
11 US Department of Health and Human Services. Guidance for Industry: Adaptive Design Clinical Trials for Drugs and Biologics. Department of Health and Human Services, 2010.
12 Berry, DA. Adaptive clinical trials: the promise and the caution. J Clin Oncol 2011; 29: 606–9.

Negative results in phase III trials of complex interventions: Cause for concern or just good science?

  • Mike J. Crawford (a1), Kirsten Barnicot (a1), Sue Patterson (a2) and Christian Gold (a3)

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Negative results in phase III trials of complex interventions: Cause for concern or just good science?

  • Mike J. Crawford (a1), Kirsten Barnicot (a1), Sue Patterson (a2) and Christian Gold (a3)
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