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Can electronic health records revive central nervous system clinical trials?

Molecular Psychiatry volume 24, pages 1096–1098 (2019)Cite this article

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There is growing frustration with clinical trials in brain diseases: rates of placebo response have increased along with failure rates, study subject recruitment has become more challenging, trial costs have increased, and research measures are widely regarded as inadequate and outdated. At the same time, the poor correspondence between clinical trial populations and real-world populations has provoked great concern [1].

On the other hand, despite the prominent exit of multiple large pharmaceutical companies previously invested in central nervous system (CNS) drug discovery, the pipeline of truly new treatments for brain diseases has begun to fill, with the risk that clinical investigation becomes a new bottleneck [2]. The question is, will 2020 molecules be studied with 1960s methodology?

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References

  1. Wisniewski SR, Rush AJ, Nierenberg AA, Gaynes BN, Warden D, Luther JF, et al. Can phase III trial results of antidepressant medications be generalized to clinical practice? A STAR*D report. Am J Psychiatry. 2009;166:599–607.

    Article  Google Scholar 

  2. Carroll J. AstraZeneca cutting 2,200 R&D jobs, slashing neuroscience in restructuring [Internet]. 2012. Available from: https://www.fiercebiotech.com/r-d/updated-astrazeneca-cutting-2-200-r-d-jobs-slashing-neuroscience-restructuring.

  3. Bech P. Rating scales in depression: limitations and pitfalls. Dialog Clin Neurosci. 2006;8:207–15.

    Google Scholar 

  4. Regier DA, Narrow WE, Clarke DE, Kraemer HC, Kuramoto SJ, Kuhl EA, et al. DSM-5 field trials in the United States and Canada, part II: test-retest reliability of selected categorical diagnoses. Am J Psychiatry. 2013;170:59–70.

    Article  Google Scholar 

  5. Sellgren C, Sheridan S, Gracias J, Xuan D, Fu T, Perlis R. Patient-specific models of microglia-mediated engulfment of synapses and neural progenitors. Mol Psychiatry. 2017;22:170–7.

    Article  CAS  Google Scholar 

  6. Grundmeier RW, Swietlik M, Bell LM. Research subject enrollment by primary care pediatricians using an electronic health record. AMIA Annu Symp Proc 2007;289–93.

  7. Phansalkar S, van der Sijs H, Tucker AD, Desai AA, Bell DS, Teich JM, et al. Drug–drug interactions that should be non-interruptive in order to reduce alert fatigue in electronic health records. J Am Med Inform Assoc JAMIA. 2013;20:489–93.

    Article  Google Scholar 

  8. Perlis RH. Abandoning personalization to get to precision in the pharmacotherapy of depression. World Psychiatr Assoc. 2016;15:228–35.

    Article  Google Scholar 

  9. Perlis RH, Iosifescu DV, Castro VM, Murphy SN, Gainer VS.Minnier J,et al. Using electronic medical records to enable large-scale studies in psychiatry: treatment resistant depression as a model. Psychol Med. 42:41–50..

    Article  Google Scholar 

  10. US Food and Drug Administration. Early Alzheimer’s Disease: developing drugs for treatment guidance for industry [Internet]. 2018. Available from: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM596728.pdf.

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Authors and Affiliations

  1. Center for Quantitative Health, Massachusetts General Hospital, Boston, MA, 02114, USA

    Roy H. Perlis & Thomas H. McCoy Jr

  2. Division of Clinical Research, Massachusetts General Hospital, Boston, MA, 02114, USA

    Maurizio Fava

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  1. Roy H. Perlis
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Correspondence to Roy H. Perlis.

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Conflict of interest

In the past three years, Roy Perlis has served on advisory boards or provided consulting to Genomind, Psy Therapeutics, RIDVentures, and Takeda. He receives patent royalties from Massachusetts General Hospital. In the past three years, Maurizio Fava reports the following research support: Alkermes, Inc., Johnson & Johnson, Axsome, Acadia Pharmaceuticals, Cerecor, Lundbeck Inc., Neuralstem, Otsuka, Taisho, Marinus Pharmaceuticals, BioHaven, Takeda, Vistagen, Relmada Therapeutics Inc., Stanley Medical Research Institute (SMRI), National Institute of Drug Abuse (NIDA), National Institute of Mental Health (NIMH), and PCORI. Dr. Fava has not done any personal consulting. Any consulting he has done has been on behalf of Massachusetts General Hospital. Dr. Fava has equity holdings in Compellis and PsyBrain Inc. Dr. Fava has patents for Sequential Parallel Comparison Design (SPCD), licensed by MGH to Pharmaceutical Product Development, LLC; a patent application for a combination of Ketamine plus Scopolamine in Major Depressive Disorder (MDD), licensed by MGH to Biohaven; and patents for pharmacogenomics of Depression Treatment with Folate. Dr. McCoy declares that he has no conflict of interest.

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Perlis, R.H., Fava, M. & McCoy, T.H. Can electronic health records revive central nervous system clinical trials?. Mol Psychiatry 24, 1096–1098 (2019). https://doi.org/10.1038/s41380-018-0278-z

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