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Neuroimaging and Clinical Trials

Neuroimaging as endpoints in clinical trials: Are we there yet? Perspective from the first Provence workshop

Molecular Psychiatry volume 16, pages 1064–1066 (2011)Cite this article

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Neuroimaging can now reveal an extraordinary amount of information about the structural, functional and biochemical characteristics of the human brain. Further understanding the biological processes underlying brain dysfunction, and how these adapt to treatment, is clearly of significance to researchers involved in medical trials. But how clinically meaningful is this information? A critical evaluation from conceptual and empirical perspectives was the goal of the first ‘Neuroimaging as Endpoints in Clinical Trials’ provence workshop, run from 2 June to 5 June 2010 in the charming village of Sernhac, France. Several thought-provoking, interlinked and recurring themes emerged and are enumerated here to further advance a fast developing field.

Patients and clinicians are generally interested in ameliorating pain, improving cognition, protecting functional independence and raising quality of life, generally accepted as primary outcomes in randomized clinical trials (RCTs). What then could motivate the search for replacing these with neuroimage-based measures? One reason is that it may make RCTs more efficient.1 If an intervention leads to only a modest clinical effect size, but yields a stronger neuroimage-based effect, then investigators could make do with fewer patients for the same power, or gain power for the same sample size. This in turn could enhance the feasibility and economics of a proposed trial. However, for the feasibility argument to hold, change on any neuroimage-based endpoint must correlate with change on the gold-standard clinical outcome.

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Acknowledgements

Special thanks to Dr Kiran Deol for her marvelous behind the scenes work organizing the workshop, as well as Marc, Patricia and all the staff of the Domaine des Escaunes who made our time so enjoyable. We also extend our gratitude to Dr Melissa Green for her initial work in creating and promoting the workshop, as well as Katherine Koulizakis for her administrative support. Finally, we thank our various drivers for their peerless knowledge of the Provencal countryside.

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Author notes

  1. Department of Psychiatry and Clinical Psychobiology, Faculty of Medicine, University of Barcelona and Institut d’Investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Barcelona, Spain

  2. School of Engineering Science, Simon Fraser University, Burnaby, BC, Canada

  3. Melbourne Neuropsychiatry Centre, Department of Psychiatry, The University of Melbourne and Melbourne Health, Melbourne, VIC, Australia

  4. Neuronal Targets DPU, GlaxoSmithKline, Philadelphia, PA, USA

  5. Department of Psychiatry & Behavioural and Clinical Neuroscience Institute, University of Cambridge, Cambridge, UK

  6. McLean Hospital, Belmont, MA, USA and Harvard Medical School, Boston, MA, USA

  7. Laboratory of Neuro Imaging, UCLA School of Medicine, Los Angeles, CA, USA

Authors and Affiliations

  1. Regenerative Neuroscience Group, Faculty of Medicine, Neuropsychiatric Institute, Prince of Wales Hospital, Randwick, Sydney, 2031, NSW, Australia

    M Valenzuela, D Bartrés-Faz, F Beg, A Fornito, E Merlo-Pich, U Müller, D Öngür, A W Toga & M Yücel

  2. Brain and Ageing Research Program, School of Psychiatry, University of New South Wales, Australia

    M Valenzuela, D Bartrés-Faz, F Beg, A Fornito, E Merlo-Pich, U Müller, D Öngür, A W Toga & M Yücel

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  1. M Valenzuela
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Correspondence to M Valenzuela.

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EM-P is an employee of GlaxoSmithKline.

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Valenzuela, M., Bartrés-Faz, D., Beg, F. et al. Neuroimaging as endpoints in clinical trials: Are we there yet? Perspective from the first Provence workshop. Mol Psychiatry 16, 1064–1066 (2011). https://doi.org/10.1038/mp.2011.62

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