E. Papadopoulos

发表

Development of Celiac Disease Therapeutics: Report of the Third Gastroenterology Regulatory Endpoints and Advancement of Therapeutics Workshop.

D. Griebel, D. Leffler, S. Kupfer, 2016, Gastroenterology.

Can we use social media to support content validity of patient-reported outcome instruments in medical product development?

P. Wicks, E. Papadopoulos, M. Rothman, 2015, Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research.

Use of Mobile Devices to Measure Outcomes in Clinical Research, 2010–2016: A Systematic Literature Review

Jennifer C. Goldsack, Marc K. Walton, Nirav Sheth, 2018, Digital Biomarkers.

Focusing on Core Patient-Reported Outcomes in Cancer Clinical Trials: Symptomatic Adverse Events, Physical Function, and Disease-Related Symptoms

Martha Donoghue, P. Keegan, R. Pazdur, 2016, Clinical Cancer Research.

Developing and Implementing Performance Outcome Assessments: Evidentiary, Methodologic, and Operational Considerations

Richard W. Bohannon, S. Coons, E. Papadopoulos, 2019, Therapeutic innovation & regulatory science.

A collaborative model for endpoint development for acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia.

L. Burke, E. Papadopoulos, S. Komo, 2012, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

Instruments to Identify Prescription Medication Misuse, Abuse, and Related Events in Clinical Trials: An ACTTION Systematic Review.

R. Dworkin, L. Burke, D. Turk, 2015, The journal of pain : official journal of the American Pain Society.

Qualification opinion on stride velocity 95th centile as a secondary endpoint in Duchenne Muscular Dystrophy measured by a valid and suitable wearable device

I. Clay, F. Muntoni, L. Servais, 2019 .

The Use of Patient‐Reported Outcome Measures in the Evaluation of Medical Products for Regulatory Approval

L. Burke, D. Kennedy, A. M. Trentacosti, 2008, Clinical pharmacology and therapeutics.

Clinical Outcome Assessments for Clinical Trials in Children

D. Patrick, L. Burke, A. Pariser, 2013 .

Alternate Endpoints and Clinical Outcome Assessments in Pediatric Ulcerative Colitis Registration Trials

Jessica J. Lee, A. Mulberg, E. Papadopoulos, 2014, Journal of pediatric gastroenterology and nutrition.

Patient-Reported Outcomes in Cancer Drug Development and US Regulatory Review: Perspectives From Industry, the Food and Drug Administration, and the Patient.

A. Gnanasakthy, E. Basch, S. Coons, 2015, JAMA oncology.

Well-Defined and Reliable Clinical Outcome Assessments for Pediatric Crohn Disease: A Critical Need for Drug Development

J. Hyams, D. Griebel, Jessica J. Lee, 2015, Journal of pediatric gastroenterology and nutrition.

Advancing Therapeutic Development for Pulmonary Morbidities Associated with Preterm Birth

Lynn D. Hudson, E. Papadopoulos, G. Baer, 2020, Therapeutic Innovation & Regulatory Science.

Use of PRO Measures to Inform Tolerability in Oncology Trials: Implications for Clinical Review, IND Safety Reporting, and Clinical Site Inspections

L. Minasian, J. R. Less, R. Pazdur, 2017, Clinical Cancer Research.

Guillain-Barré and Miller Fisher syndromes occurring with tumor necrosis factor alpha antagonist therapy.

E. Papadopoulos, A. Baer, Elektra J. Papadopoulos, 2006, Arthritis and rheumatism.

Pain palliation measurement in cancer clinical trials: The US Food and Drug Administration perspective

E. Basch, L. Burke, R. Pazdur, 2014, Cancer.

Discrepancies between registered and published primary outcome specifications in analgesic trials: ACTTION systematic review and recommendations

M. Rowbotham, R. Dworkin, L. Burke, 2013, PAIN®.

Patient-Reported Outcomes in Glomerular Disease.

P. Merkel, N. Carlozzi, D. Gipson, 2017, Clinical journal of the American Society of Nephrology : CJASN.

Steps Toward Harmonization for Clinical Development of Medicines in Pediatric Ulcerative Colitis—A Global Scientific Discussion, Part 1: Efficacy Endpoints and Disease Outcome Assessments

D. Griebel, A. Mulberg, E. Papadopoulos, 2014, Journal of pediatric gastroenterology and nutrition.

Focusing on Core Patient-Reported Outcomes in Cancer Clinical Trials—Response

Martha Donoghue, P. Keegan, R. Pazdur, 2016, Clinical Cancer Research.

Development of a harmonized patient-reported outcome questionnaire to assess myelofibrosis symptoms in clinical trials.

J. Paty, C. Gwaltney, A. Dueck, 2017, Leukemia research.