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

British Journal of Psychiatry

Volumn 209, Issue 1, 2016, Pages 6-8

  Crawford, Mike J ^a   Barnicot, Kirsten ^a   Patterson, Sue ^b   Gold, Christian ^c  

^a IMPERIAL COLLEGE LONDON   (United Kingdom)

^b Metro North Mental Health   (Australia)

^c STATOIL   (Norway)

Author keywords

[No Author keywords available]

Indexed keywords

CONTROLLED CLINICAL TRIAL; EXPLORATORY RESEARCH; HUMAN; MENTAL HEALTH; PHASE 3 CLINICAL TRIAL; STUDY DESIGN; PHASE 3 CLINICAL TRIAL (TOPIC); STANDARDS;

CLINICAL TRIALS, PHASE III AS TOPIC; HUMANS;

EID: 84978435526     PISSN: 00071250     EISSN: 14721465     Source Type: Journal    
DOI: 10.1192/bjp.bp.116.181628     Document Type: Review

References (12)

1. Priebe S, Savill M, Wykes T, Bentall RP, Reininghaus U, Lauber C, et al. Effectiveness of group body psychotherapy for negative symptoms of schizophrenia: multicentre randomised controlled trial. Br J Psychiatry 2016; 209: 54-61.
2. Crawford MJ, Killaspy H, Barnes TRE, Barrett B, Byford S, Clayton K, et al. Group art therapy as an adjunctive treatment for people with schizophrenia: multicentre pragmatic randomised trial. BMJ 2012; 344: e846.
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.
5. Geller J. Community treatment orders for patients with psychosis. Lancet 2013; 382: 502.
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: 6-11.
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.