2018
The Open Translational Science in Schizophrenia (OPTICS) project: an open-science project bringing together Janssen clinical trial and NIMH data
Wilcox MA, Savitz AJ, Addington AM, Gray GS, Guinan EC, Jackson JW, Lehner T, Normand SL, Ranu H, Senthil G, Spertus J, Valeri L, Ross JS. The Open Translational Science in Schizophrenia (OPTICS) project: an open-science project bringing together Janssen clinical trial and NIMH data. Schizophrenia 2018, 4: 14. PMID: 29950580, PMCID: PMC6021398, DOI: 10.1038/s41537-018-0055-7.Commentaries, Editorials and LettersClinical trialsOverall public health burdenSchizophrenia ProjectPublic health burdenClinical trial dataReal-world studyTranslational scienceHarvard CatalystHealth burdenTherapeutic safetyTrial dataBrain diseasesBiology of diseaseGold standardBest treatmentPharmaceutical safetyDisease etiologyTrialsDiseaseEfficacyProject investigatorsSafetyEtiologySchizophrenia
2017
US Food and Drug Administration Clearance of Moderate‐Risk Otolaryngologic Devices via the 510(k) Process, 1997‐2016
Rathi VK, Gadkaree SK, Ross JS, Kozin ED, Sethi RK, Naunheim MR, Puram SV, Gray ST. US Food and Drug Administration Clearance of Moderate‐Risk Otolaryngologic Devices via the 510(k) Process, 1997‐2016. Otolaryngology 2017, 157: 608-617. PMID: 28786317, DOI: 10.1177/0194599817721689.Peer-Reviewed Original ResearchConceptsPremarket evidenceClinical evidenceClinical performance dataUS FoodAvailable FDA documentsFDA documentsEvidence of safetyDrug Administration clearanceOne-quarterNonclinical evidenceClinical practiceDrug AdministrationFDA clearanceOne-thirdTwo-thirdsClearanceFDATherapeutic devicesEvidenceSafetyOtolaryngologistsMajorityOtologic