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The New England Journal of Medicine, ISSN 0028-4793, 07/2017, Volume 377, Issue 1, pp. 62 - 70
This review considers master protocols, which involve the study of one or more interventions in multiple diseases or of a single disease with multiple... 
MEDICINE, GENERAL & INTERNAL | PHASE-II | TRIAL DESIGN | ERA | ADAPTIVE RANDOMIZATION | CLINICAL-TRIALS | Disease | Research Design | Humans | Clinical Protocols | Therapeutics | Clinical Trials as Topic - organization & administration | Intervention | Clinical trials | Medical research | Protocol
Journal Article
Journal of the American Statistical Association, ISSN 0162-1459, 10/2019, Volume 114, Issue 528, pp. 1427 - 1435
Color versions of one or more of the figures in the article can be found online at www.tandfonline.com/r/JASA . Abstract-Each year, the Journal of the American... 
STATISTICS & PROBABILITY | Electronic publishing
Journal Article
Chest, ISSN 0012-3692, 03/2019, Volume 155, Issue 3, pp. 519 - 527
Background: Aspirin use in COPD has been associated with reduced all-cause mortality in meta-regression analysis with few equivocal studies. However, the... 
acute exacerbation of chronic bronchitis | dyspnea | antiplatelet drugs | quality of life | COPD | MORTALITY | PREVENTION | OBSTRUCTIVE PULMONARY-DISEASE | REDUCTION | RESPIRATORY SYSTEM | INFLAMMATION | ACUTE EXACERBATION | CRITICAL CARE MEDICINE | Severity of Illness Index | Pulmonary Disease, Chronic Obstructive - diagnosis | United States - epidemiology | Glucocorticoids - therapeutic use | Prospective Studies | Correlation of Data | Humans | Middle Aged | Respiratory Function Tests - methods | Male | Symptom Assessment - methods | Pulmonary Disease, Chronic Obstructive - physiopathology | Pulmonary Disease, Chronic Obstructive - epidemiology | Symptom Assessment - statistics & numerical data | Symptom Flare Up | Anti-Bacterial Agents - therapeutic use | Female | Aspirin - therapeutic use | Platelet Aggregation Inhibitors - therapeutic use | Pulmonary Disease, Chronic Obstructive - drug therapy | Treatment outcome | Aspirin | Lung diseases, Obstructive | Patient outcomes | Analysis | Dosage and administration | Drug therapy | AECOPD, acute exacerbation of COPD | MDCT, multidetector row CT | CAT, COPD Assessment Test | SPIROMICS, Subpopulations and Intermediate Outcome Measures in COPD Study | IRR, incidence rate ratio | mMRC, modified Medical Research Council | SGRQ, St. George’s Respiratory Questionnaire | 6MWD, 6-min walk distance
Journal Article
Journal Article
Statistics in Medicine, ISSN 0277-6715, 07/2016, Volume 35, Issue 17, pp. 2853 - 2864
Journal Article
Statistics in Biopharmaceutical Research, ISSN 1946-6315, 01/2019, Volume 11, Issue 1, pp. 1 - 12
A year after joining the FDA in 2011 as Director of the Office of Biostatistics in the Center for Drug Evaluation and Research (CDER), I prepared a talk, and... 
Estimands | Statistical policy | Master protocols | Bayesian methods | Regulatory guidance | DESIGN | COMBINING MULTIPLE COMPARISONS | CLINICAL-TRIALS | MATHEMATICAL & COMPUTATIONAL BIOLOGY | MISSING DATA | STATISTICS & PROBABILITY | THERAPIES
Journal Article
Statistics in Biopharmaceutical Research, ISSN 1946-6315, 01/2019, Volume 11, Issue 1, pp. 30 - 32
Journal Article
Therapeutic Innovation & Regulatory Science, ISSN 2168-4790, 1/2014, Volume 48, Issue 1, pp. 10 - 19
The number of statistical challenges facing regulators remains high, as does the importance of statistical thinking in the regulatory decision-making process.... 
data quality | sensitivity analysis | meta-analysis | statistical reviews | regulatory guidance | missing data | adaptive design | MEDICAL INFORMATICS | PHARMACOLOGY & PHARMACY | Studies | Science | Product development | Pharmaceutical industry | Decision making | Innovations
Journal Article
Journal Article
Journal Article
American Journal of Psychiatry, ISSN 0002-953X, 9/2011, Volume 168, Issue 9, pp. 947 - 956
Patients with a BMI of 27 or higher and a non-HDL cholesterol level of 130 mg/dl or higher on stable doses of olanzapine, quetiapine, or risperidone were... 
BEHAVIORAL-THERAPY | METFORMIN | MULTICENTER | IMPACT | PSYCHIATRY | OVERWEIGHT | DOUBLE-BLIND | DISORDER | INDUCED WEIGHT-GAIN | CATIE SCHIZOPHRENIA TRIAL | 1ST-EPISODE SCHIZOPHRENIA | Antipsychotic Agents - adverse effects | Cholesterol - blood | Humans | Body Weight - drug effects | Risk | Psychotic Disorders - blood | Aripiprazole | Diet, Reducing | Psychiatric Status Rating Scales | Dibenzothiazepines - therapeutic use | Exercise | Quinolones - adverse effects | Risperidone - therapeutic use | Schizophrenia - diagnosis | Antipsychotic Agents - therapeutic use | Dibenzothiazepines - adverse effects | Quinolones - therapeutic use | Risperidone - adverse effects | Cholesterol, LDL - blood | Hypercholesterolemia - prevention & control | Body Mass Index | Psychotic Disorders - diagnosis | Hypercholesterolemia - blood | Schizophrenia - blood | Psychotic Disorders - psychology | Quetiapine Fumarate | Treatment Outcome | Combined Modality Therapy | Piperazines - therapeutic use | Piperazines - adverse effects | Triglycerides - blood | Benzodiazepines - adverse effects | Psychotic Disorders - drug therapy | Hypercholesterolemia - chemically induced | Schizophrenia - drug therapy | Drug Substitution | Benzodiazepines - therapeutic use | Prevention | Complications and side effects | Olanzapine | Patient outcomes | Schizophrenia | Metabolic diseases | Dosage and administration | Drug therapy | Comparative analysis | Quetiapine | Risk factors
Journal Article
Journal Article
Annals of the American Thoracic Society, ISSN 2325-6621, 02/2019, Volume 16, Issue 2, pp. 200 - 208
Rationale: Despite awareness of chronic obstructive pulmonary disease (COPD) treatment recommendations, uptake is poor. The Subpopulations and Intermediate... 
Chronic obstructive pulmonary disease | Treatment | Inhaled therapy | treatment | MANAGEMENT | RESPIRATORY SYSTEM | GUIDELINES | BARRIERS | inhaled therapy | CLINICAL-PRACTICE | ADHERENCE | chronic obstructive pulmonary disease | COPD
Journal Article