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Editorial
. 2023 Jan 19:13:1079006.
doi: 10.3389/fpsyt.2022.1079006. eCollection 2022.

Editorial: Precision medicine approaches for heterogeneous conditions such as autism spectrum disorders (The need for a biomarker exploration phase in clinical trials - Phase 2m)

Affiliations
Editorial

Editorial: Precision medicine approaches for heterogeneous conditions such as autism spectrum disorders (The need for a biomarker exploration phase in clinical trials - Phase 2m)

David Q Beversdorf et al. Front Psychiatry. .
No abstract available

Keywords: autism (ASD); biomarkers; genetics; heterogeneity; treatment.

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Conflict of interest statement

DB consultant for YAMO Pharma, Impel Pharma, Scioto Biosci, Quadrant Biosci, Stalicla Biosci, and Human Health. EA received consultation fees from F. Hoffmann-La Roche AG Pharmaceuticals, Impel neuropharma, Cell-El Therapeutics Ltd., ONO Pharma USA, Inc.; research funding from Roche, Anavex and Sanofi-Aventis, and SynapDx; in kind supports from AMO pharma and CRA; editorial honoraria from Wiley; book royalties from Springer and APPI, and has served on advisory boards at Roche and Quadrant Biosciences. AH consultant for IAMA Therapeutics, Jazz Pharmaceuticals, and Beaming Health. Has equity options in Quadrant Biosciences and has an investor stake in SCAN-R LLC. PW is an employee of Clinical Research Associates, LLC. CE consultant to Scioto Bioscience, Forge, and Stalicla. Nothing else to report. None of my consulting is related directly to the content of this Frontiers manuscript. TF has received funding or research support from, acted as a consultant to, received travel support from, and/or received a speaker's honorarium from the PTEN Research Foundation, SYNGAP Research Fund, Malan Syndrome Foundation, ADNP Kids Research Foundation, Quadrant Biosciences, Autism Speaks, Impel NeuroPharma, F. Hoffmann-La Roche AG Pharmaceuticals, the Cole Family Research Fund, Simons Foundation, Ingalls Foundation, Forest Laboratories, Ecoeos, IntegraGen, Kugona LLC, Shire Development, Bristol-Myers Squibb, Roche Pharma, MaraBio, National Institutes of Health, and the Brain and Behavior Research Foundation, has equity options in Quadrant Biosciences and MaraBio, and has an investor stake in Autism EYES LLC and iSCAN-R. JV-V received research funding from NIH, Simons Foundation, Roche, Janssen, Novartis, Seaside Therapeutics, Acadia, Yamo, MapLight, and SynapDx. Advisory board or consulting with Simons Foundation, Autism Speaks, Brain Behavior Research Foundation, Roche, and Novartis. Editorial stipend from Wiley.

Figures

Figure 1
Figure 1
Schematic representing the location of a phase 2m in clinical trials, after phase 1 and phase 2, and before phase 3, if the need for a biomarker exploration phase is warranted based on the nature of the clinical condition. The dashed arrow moving directly from phase 2 to phase 3 might be appropriate for some conditions, but incorporating the phase 2m seems warranted in conditions such as ASD.

Comment on

  • Editorial on the Research Topic Precision medicine approaches for heterogeneous conditions such as autism spectrum disorders (The need for a biomarker exploration phase in clinical trials - Phase 2m)

References

    1. De Rubeis S, He X, Goldberg AP, Poultney CS, Samocha K, Cicek AE, et al. . Synaptic, transcriptional and chromatin genes disrupted in autism. Nature. (2014) 515:209–15. 10.1038/nature13772 - DOI - PMC - PubMed
    1. Beversdorf DQ, Wang P, Barnes G, Weisskopf M, Hardan A, Hu V, et al. . Phenotyping, etiological factors, and biomarkers: toward precision medicine in autism spectrum disorder. J Dev Behav Pediatr. (2016) 37:659–73. 10.1097/DBP.0000000000000351 - DOI - PMC - PubMed
    1. Bear MF, Huber KM, Warren ST. The mGluR theory of fragile X mental Retardation. Trends Neurosci. (2004) 27:370–7. 10.1016/j.tins.2004.04.009 - DOI - PubMed
    1. Chez MG, Burton Q, Dowling T, Chang M, Khanna P, Kramer C. Memantine as adjunctive therapy in children diagnosed with autistic spectrum disorders: an observation of initial clinical response and maintenance tolerability. J Child Neruol. (2007) 22:574–9. 10.1177/0883073807302611 - DOI - PubMed
    1. Erickson CA, Posey DJ, Stigler KA, Mullett J, Katschke AR, McDougle CJ. A retrospective study of memantine in children and adolescents with pervasive developmental disorders. Psychopharmacol. (2007) 191:141–7. 10.1007/s00213-006-0518-9 - DOI - PubMed

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