R. O’Neill

发表

Patient-reported outcomes to support medical product labeling claims: FDA perspective.

D. Patrick, L. Burke, J. Powers, 2007, Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research.

Use of Screening Algorithms and Computer Systems to Efficiently Signal Higher-Than-Expected Combinations of Drugs and Events in the US FDA’s Spontaneous Reports Database

R. O’Neill, A. Szarfman, Stella G. Machado, 2002, Drug safety.

Regulatory Perspectives on Multiplicity in Adaptive Design Clinical Trials throughout a Drug Development Program

Sue-Jane Wang, Robert O'Neill, Sue-Jane Wang, 2011, Journal of biopharmaceutical statistics.

Regulatory and Scientific Issues Regarding Use of Foreign Data in Support of New Drug Applications in the United States: An FDA Perspective

R. O’Neill, S‐M Huang, R. Temple, 2013, Clinical pharmacology and therapeutics.

Better Reporting of Harms in Randomized Trials: An Extension of the CONSORT Statement

J. Ioannidis, D. Moher, D. Altman, 2004, Annals of Internal Medicine.

Approaches to evaluation of treatment effect in randomized clinical trials with genomic subset

Sue-Jane Wang, R. O’Neill, H. M. Hung, 2007, Pharmaceutical statistics.

Statistical Considerations for Testing Multiple Endpoints in Group Sequential or Adaptive Clinical Trials

H M James Hung, Sue-Jane Wang, Robert O'Neill, 2007, Journal of biopharmaceutical statistics.

Statistical considerations in evaluating pharmacogenomics-based clinical effect for confirmatory trials

Robert T O'Neill, Sue-Jane Wang, Sue-Jane Wang, 2010, Clinical trials.

Non-inferiority trials

Sue-Jane Wang, R. O’Neill, H. M. Hung, 2017 .

Non-Inferiority Trial

Sue-Jane Wang, R. O’Neill, H. M. Hung, 2007 .

Multiplicity in confirmatory clinical trials: a case study with discussion from a JSM panel

J. Hsu, Sue-Jane Wang, F. Bretz, 2015, Statistics in medicine.

Does Research Synthesis Have a Place in Drug Regulatory Policy? Synopsis of Issues: Assessment of Efficacy and Drug Approval

R. O’Neill, C. Anello, 1996 .

Reflections on Professor Jerome Cornfield’s contributions to the US Food and Drug Administration

R. O’Neill, 2013, Clinical trials.

Developing the evidence base for applying pharmacogenomics: proceeds from DIA Workshop IV--Breakout Session 1.

R. O’Neill, C. Hunt, A. Power, 2009, Pharmacogenomics.

Independence of the statistician who analyses unblinded data

G. Campbell, R. O’Neill, R. Temple, 2004, Statistics in medicine.

Multicentre trials: a US regulatory perspective

R. O’Neill, S. Dubey, C. Anello, 2005, Statistical methods in medical research.

Reacting to crises: The COVID-19 impact on biostatistics/epidemiology

R. O’Neill, 2020, Contemporary Clinical Trials.

A Method for Post-Marketing Screening of Adverse Reactions to Drugs Initial Results

R. O’Neill, D. Knapp, A. C. Rossi, 1980, Drug intelligence & clinical pharmacy.

Discussion: M K B Parmar and David Machin, monitoring clinical trials; Experience of, and proposals under consideration by the Cancer Therapy Committee of the British Medical Research Council

D. DeMets, S. Yusuf, S. Pocock, 1993 .

Recent Methodological Issues in Drug Evaluation: A Perspective from the United States*

R. O’Neill, 1995 .

Promoting the Science of Regulatory Statistics in Support of Regulatory Decisionmaking

R. O’Neill, 2013 .

A Regulatory Perspective on Choice of Margin and Statistical Inference Issue in Non‐inferiority Trials

Sue-Jane Wang, H M James Hung, Robert O'Neill, 2005, Biometrical journal. Biometrische Zeitschrift.

On sample sizes to estimate the protective efficacy of a vaccine.

R. O’Neill, Robert T. O'Neill, 1988, Statistics in medicine.

MMRM vs. LOCF: A Comprehensive Comparison Based on Simulation Study and 25 NDA Datasets

Robert O'Neill, Ohidul Siddiqui, H M James Hung, 2009, Journal of biopharmaceutical statistics.

Guidelines for quality assurance in multicenter trials: a position paper.

S L George, F W Rockhold, R. O’Neill, 1998, Controlled clinical trials.

Adaptive patient enrichment designs in therapeutic trials

Sue-Jane Wang, Robert T O'Neill, H M James Hung, 2009, Biometrical journal. Biometrische Zeitschrift.

Postmarketing Surveillance of New Drugs and Assessment of Risk

R. O’Neill, C. Anello, R. O'neill, 2005 .

The Prevention and Treatment of Missing Data in Clinical Trials: An FDA Perspective on the Importance of Dealing With It

R T O'Neill, R. O’Neill, R. Temple, 2012, Clinical pharmacology and therapeutics.

Methodological issues with adaptation of clinical trial design

Sue-Jane Wang, H M James Hung, Robert T O'Neill, 2006, Pharmaceutical statistics.

A Regulatory View on Adaptive/Flexible Clinical Trial Design

Robert T O'Neill, Sue-Jane Wang, H M James Hung, 2006, Biometrical journal. Biometrische Zeitschrift.

Paradigms for adaptive statistical information designs: practical experiences and strategies

Sue-Jane Wang, Robert O'Neill, H M James Hung, 2012, Statistics in medicine.

The behavior of the P-value when the alternative hypothesis is true.

R T O'Neill, P Bauer, R. O’Neill, 1997, Biometrics.

Some FDA perspectives on data monitoring in clinical trials in drug development.

R. O’Neill, 1993, Statistics in medicine.

Statistical Analyses of Adverse Event Data from Clinical Trials

R. O’Neill, 1987, Drug information journal.

Discovery of adverse drug reactions. A comparison of selected phase IV studies with spontaneous reporting methods.

D E Knapp, R T O'Neill, C Anello, 1983, JAMA.

Short of complete abstinence: an analysis exploration of multiple drinking episodes in alcoholism treatment trials.

Robert T O'Neill, Sue-Jane Wang, Sue-Jane Wang, 2002, Alcoholism, clinical and experimental research.

Pharmaceutical Risk Assessment and Predictive Enrichment to Maximize Benefit and Minimize Risk: Issues in Product Life Cycle Evaluation

Robert T. O'Neill, R. O’Neill, R. O'neill, 2013 .

Secondary endpoints cannot be validly analyzed if the primary endpoint does not demonstrate clear statistical significance.

R T O'Neill, R. O’Neill, R. O'neill, 1997, Controlled clinical trials.

Adapting the sample size planning of a phase III trial based on phase II data

H M James Hung, Robert T O'Neill, Sue-Jane Wang, 2006, Pharmaceutical statistics.

Does Research Synthesis Have a Place in Drug Regulatory Policy? Synopsis of Issues: Assessment of Safety and Postmarketing Surveillance

R. O’Neill, C. Anello, 1996 .

Impacts on type I error rate with inappropriate use of learn and confirm in confirmatory adaptive design trials

Sue-Jane Wang, H. M. James Hung, Robert T. O'Neill, 2010, Biometrical journal. Biometrische Zeitschrift.

Biostatistical considerations in pharmacovigilance and pharmacoepidemiology: linking quantitative risk assessment in pre-market licensure application safety data, post-market alert reports and formal epidemiological studies.

R T O'Neill, R. O’Neill, 1998, Statistics in medicine.

Adaptive design clinical trials and trial logistics models in CNS drug development

Robert O'Neill, Sue-Jane Wang, H. M. James Hung, 2011, European Neuropsychopharmacology.

A Perspective on Characterizing Benefits and Risks Derived from Clinical Trials: Can We Do More?

Robert T. O'Neill, R. O’Neill, R. O'neill, 2008 .

Consideration of regional difference in design and analysis of multi‐regional trials

H M James Hung, Robert T O'Neill, Sue-Jane Wang, 2010, Pharmaceutical statistics.

Case–Control Study, Sequential †

R. O’Neill, R. O'neill, 2014 .

Case–Control Study, Sequential

R. O’Neill, R. O'neill, 2005 .

Commentary on 'Alpha calculus in clinical trials: considerations and commentary for the new millennium'.

R. O’Neill, 2000, Statistics in medicine.