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Biometric monitoring devices for assessing end points in clinical trials: developing an ecosystem.
Arnerić SP, Cedarbaum JM, Khozin S, Papapetropoulos S, Hill DL, Ropacki M, Rhodes J, Dacks PA, Hudson LD, Gordon MF, Kern VD, Romero K, Vradenburg G, Au R, Karlin DR, Facheris MF, Fitzer-Attas CJ, Vitolo OV, Wang J, Miller BM, Kaye JA. Arnerić SP, et al. Among authors: romero k. Nat Rev Drug Discov. 2017 Oct;16(10):736. doi: 10.1038/nrd.2017.153. Epub 2017 Sep 22. Nat Rev Drug Discov. 2017. PMID: 28935908 No abstract available.
Big data to smart data in Alzheimer's disease: The brain health modeling initiative to foster actionable knowledge.
Geerts H, Dacks PA, Devanarayan V, Haas M, Khachaturian ZS, Gordon MF, Maudsley S, Romero K, Stephenson D; Brain Health Modeling Initiative (BHMI). Geerts H, et al. Among authors: romero k. Alzheimers Dement. 2016 Sep;12(9):1014-1021. doi: 10.1016/j.jalz.2016.04.008. Epub 2016 May 26. Alzheimers Dement. 2016. PMID: 27238630 Free article. Review.
Cerebrospinal Fluid Biomarkers for Alzheimer's Disease: A View of the Regulatory Science Qualification Landscape from the Coalition Against Major Diseases CSF Biomarker Team.
Arnerić SP, Batrla-Utermann R, Beckett L, Bittner T, Blennow K, Carter L, Dean R, Engelborghs S, Genius J, Gordon MF, Hitchcock J, Kaplow J, Luthman J, Meibach R, Raunig D, Romero K, Samtani MN, Savage M, Shaw L, Stephenson D, Umek RM, Vanderstichele H, Willis B, Yule S. Arnerić SP, et al. Among authors: romero k. J Alzheimers Dis. 2017;55(1):19-35. doi: 10.3233/JAD-160573. J Alzheimers Dis. 2017. PMID: 27662307 Free PMC article. Review.
The Qualification of an Enrichment Biomarker for Clinical Trials Targeting Early Stages of Parkinson's Disease.
Stephenson D, Hill D, Cedarbaum JM, Tome M, Vamvakas S, Romero K, Conrado DJ, Dexter DT, Seibyl J, Jennings D, Nicholas T, Matthews D, Xie Z, Imam S, Maguire P, Russell D, Gordon MF, Stebbins GT, Somer E, Gallagher J, Roach A, Basseches P, Grosset D, Marek K; Critical Path for Parkinson’s Consortium. Stephenson D, et al. Among authors: romero k. J Parkinsons Dis. 2019;9(3):553-563. doi: 10.3233/JPD-191648. J Parkinsons Dis. 2019. PMID: 31306141 Free PMC article.
Molecular Neuroimaging of the Dopamine Transporter as a Patient Enrichment Biomarker for Clinical Trials for Early Parkinson's Disease.
Romero K, Conrado D, Burton J, Nicholas T, Sinha V, Macha S, Ahamadi M, Cedarbaum J, Seibyl J, Marek K, Basseches P, Hill D, Somer E, Gallagher J, Dexter DT, Roach A, Stephenson D; Critical Path for Parkinson's (CPP) Consortium; Parkinson's Progression Markers Initiative (PPMI). Romero K, et al. Clin Transl Sci. 2019 May;12(3):240-246. doi: 10.1111/cts.12619. Epub 2019 Mar 18. Clin Transl Sci. 2019. PMID: 30706986 Free PMC article.
Dopamine Transporter Neuroimaging as an Enrichment Biomarker in Early Parkinson's Disease Clinical Trials: A Disease Progression Modeling Analysis.
Conrado DJ, Nicholas T, Tsai K, Macha S, Sinha V, Stone J, Corrigan B, Bani M, Muglia P, Watson IA, Kern VD, Sheveleva E, Marek K, Stephenson DT, Romero K; Critical Path for Parkinson's (CPP) Parkinson's Disease Modeling and Simulation Working Group. Conrado DJ, et al. Among authors: romero k. Clin Transl Sci. 2018 Jan;11(1):63-70. doi: 10.1111/cts.12492. Epub 2017 Jul 27. Clin Transl Sci. 2018. PMID: 28749580 Free PMC article.
Coalition Against Major Diseases: Precompetitive Collaborations and Regulatory Paths to Accelerating Drug Development for Neurodegenerative Diseases.
Stephenson D, Aviles E, Bain LJ, Brumfield M, Carrillo M, Comery TA, Compton C, Corrigan B, Gordon MF, Jack CR Jr, Katz R, Logovinsky V, Satlin A, Marek K, Nicholas T, Polhamus D, Angersbach BS, Raghavan N, Romano G, Romero K, Shaw L, Woodcock J, Vradenburg G, Isaac M. Stephenson D, et al. Among authors: romero k. Ther Innov Regul Sci. 2013 Nov;47(6):632-638. doi: 10.1177/2168479013498386. Ther Innov Regul Sci. 2013. PMID: 30235546
226 results