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1. Full Text Pediatric Antihypertensive Trial Failures: Analysis of End Points and Dose Range
by Benjamin, Daniel K and Smith, P Brian and Jadhav, Pravin and Gobburu, Jogarao V and Murphy, M Dianne and Hasselblad, Vic and Baker-Smith, Carissa and Califf, Robert M and Li, Jennifer S
Hypertension, ISSN 0194-911X, 04/2008, Volume 51, Issue 4, pp. 834 - 840
Historically, drugs prescribed for children have not been studied in pediatric populations. Since 1997, however, a 6-month extension of marketing rights is... 
Clinical trials | Pediatrics | Randomized | Pediatric epidemiology | Antihypertensive agents | Dose-response relationship | EFFICACY | SAFETY | antihypertensive agents | BLOOD-PRESSURE | REPRODUCIBILITY | pediatric epidemiology | PHARMACOKINETICS | pediatrics | DOUBLE-BLIND | PERIPHERAL VASCULAR DISEASE | clinical trials | dose-response relationship | randomized | HYPERTENSIVE CHILDREN | Body Weight | United States Food and Drug Administration - statistics & numerical data | United States | Humans | Databases, Factual - statistics & numerical data | Antihypertensive Agents - administration & dosage | Hypertension - drug therapy | Randomized Controlled Trials as Topic - standards | Dose-Response Relationship, Drug | Treatment Failure | Adolescent | Blood Pressure - drug effects | Hypertension - epidemiology | Child | Index Medicus
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2. Full Text Analyses of Efficacy End Points in a Controlled Trial of Interferon-γ1b for Idiopathic Pulmonary Fibrosis
by King, Talmadge E and Safrin, Sharon and Starko, Karen M and Brown, Kevin K and Noble, Paul W and Raghu, Ganesh and Schwartz, David A
Chest, ISSN 0012-3692, 01/2005, Volume 127, Issue 1, pp. 171 - 177
Idiopathic pulmonary fibrosis (IPF) is a devastating disease, yet validated, reliable criteria for evaluating patient response to therapies in clinical trials... 
mortality | efficacy end points | idiopathic pulmonary fibrosis | percentage of predicted FVC | arterial-alveolar pressure gradient | Percentage of predicted FVC | Arterial-alveolar pressure gradient | Efficacy end points | Idiopathic pulmonary fibrosis | Mortality
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3. Full Text End Points for Colon Cancer Adjuvant Trials: Observations and Recommendations Based on Individual Patient Data From 20,898 Patients Enrolled Onto 18 Randomized Trials From the ACCENT Group
by Daniel J. Sargent and Smitha Patiyil and Greg Yothers and Daniel G. Haller and Richard Gray and Jacqueline Benedetti and Marc Buyse and Roberto Labianca and Jean Francois Seitz and Christopher J. O'Callaghan and Guido Francini and Axel Grothey and Michael O'Connell and Paul J. Catalano and David Kerr and Erin Green and Harry S. Wieand and Richard M. Goldberg and Aimery de Gramont and ACCENT Group
Journal of Clinical Oncology, ISSN 0732-183X, 10/2007, Volume 25, Issue 29, pp. 4569 - 4574
Purpose The traditional end point for colon adjuvant clinical trials is overall survival (OS). We previously validated disease-free survival (DFS) after 3-year... 
LEUCOVORIN | THERAPY | PLUS IRINOTECAN | EFFICACY | ONCOLOGY | FLUOROURACIL | METASTATIC COLORECTAL-CANCER | CHEMOTHERAPY | STAGE-II | DUKES B | LEVAMISOLE | Colonic Neoplasms - therapy | Colorectal Neoplasms - mortality | Recurrence | Colonic Neoplasms - mortality | Data Interpretation, Statistical | Randomized Controlled Trials as Topic - statistics & numerical data | Humans | Middle Aged | Proportional Hazards Models | Male | Treatment Outcome | Disease-Free Survival | Clinical Trials, Phase III as Topic | Colorectal Neoplasms - therapy | Time Factors | Chemotherapy, Adjuvant - methods | Female | Aged | Index Medicus
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4. Full Text Analyses of efficacy end points in a controlled trial of interferon-gamma 1b for idiopathic pulmonary fibrosis
by King, TE and Safrin, S and Starko, KM and Brown, KK and Noble, PW and Raghu, G and Schwartz, DA
CHEST, ISSN 0012-3692, 01/2005, Volume 127, Issue 1, pp. 171 - 177
Background: Idiopathic pulmonary fibrosis (IPF) is a devastating disease, yet validated, reliable criteria for evaluating patient response to therapies in... 
SURVIVAL | efficacy end points | RESPIRATORY SYSTEM | mortality | INTERSTITIAL PNEUMONIA | idiopathic pulmonary fibrosis | percentage of predicted FVC | arterial-alveolar pressure gradient | GAMMA-1B
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5. Full Text Kidney Disease End Points in a Pooled Analysis of Individual Patient–Level Data From a Large Clinical Trials Program of the Dipeptidyl Peptidase 4 Inhibitor Linagliptin in Type 2 Diabetes
by Cooper, Mark E., MBBS, PhD and Perkovic, Vlado, MBBS, PhD and McGill, Janet B., MD and Groop, Per-Henrik, MD, DMSC and Wanner, Christoph, MD and Rosenstock, Julio, MD and Hehnke, Uwe, MSc and Woerle, Hans-Juergen, MD and von Eynatten, Maximilian, MD
American Journal of Kidney Diseases, ISSN 0272-6386, 2015, Volume 66, Issue 3, pp. 441 - 449
Background Although assessment of cardiovascular safety is mandated by regulatory agencies for the development of new drugs to treat type 2 diabetes,... 
Nephrology | Dipeptidyl peptidase 4 (DPP-4) inhibition | albuminuria | hyperglycemia | pooled analysis | linagliptin | glucose-lowering therapy | kidney disease end points | renal function | glucose control | renal risk | type 2 diabetes mellitus (T2DM) | Index Words Dipeptidyl peptidase 4 (DPP-4) inhibition | PLACEBO | EFFICACY | RISK | MELLITUS | DPP-4 INHIBITION | DOUBLE-BLIND | UROLOGY & NEPHROLOGY | CARDIOVASCULAR SAFETY | OUTCOMES | ROSIGLITAZONE | SEVERE RENAL IMPAIRMENT | Hypoglycemic Agents - therapeutic use | Dipeptidyl-Peptidase IV Inhibitors - therapeutic use | Humans | Middle Aged | Male | Treatment Outcome | Randomized Controlled Trials as Topic | Clinical Trials, Phase III as Topic | Quinazolines - therapeutic use | Female | Aged | Diabetic Nephropathies - epidemiology | Linagliptin | Purines - therapeutic use | Diabetes Mellitus, Type 2 - drug therapy | Diabetic Nephropathies - prevention & control | Clinical Trials, Phase II as Topic | Index Medicus
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6. Full Text Composite End Points in Acute Heart Failure Research: Data Simulations Illustrate the Limitations
by Brown, Paul M., MSc and Anstrom, Kevin J., PhD and Felker, G. Michael, MD and Ezekowitz, Justin A., MBBCh, MSc
Canadian Journal of Cardiology, ISSN 0828-282X, 2016, Volume 32, Issue 11, pp. 1356.e21 - 1356.e28
Abstract Composite end points are frequently used in clinical trials of investigational treatments for acute heart failure, eg, to boost statistical power and... 
Cardiovascular | ISSUES | DESIGN | CARDIAC & CARDIOVASCULAR SYSTEMS | THERAPY | EFFICACY | RATIONALE | CLINICAL-TRIALS | DEVICES | Heart Failure - therapy | Treatment Outcome | Research Design | Humans | Endpoint Determination | Randomized Controlled Trials as Topic | Index Medicus
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7. Full Text A systematic review of pharmacotherapeutic clinical trial end-points for bronchiectasis in adults
by Crichton, ML and Aliberti, S and Chalmers, JD
EUROPEAN RESPIRATORY REVIEW, ISSN 0905-9180, 03/2019, Volume 28, Issue 151, p. 180108
Bronchiectasis is an increasing clinical problem, but multiple recent clinical trials have failed to reach their primary end-point. Difficulties in achieving... 
LONG-TERM | EFFICACY | RESPIRATORY SYSTEM | CYSTIC FIBROSIS BRONCHIECTASIS | DOUBLE-BLIND | EXACERBATIONS | PHASE-II | QUALITY-OF-LIFE | AZITHROMYCIN | QUESTIONNAIRE | DRY POWDER | Endpoint Determination - standards | Bronchiectasis - drug therapy | Humans | Respiratory System Agents - therapeutic use | Treatment Outcome | Lung - physiopathology | Bronchiectasis - diagnosis | Disease Progression | Recovery of Function | Lung - drug effects | Quality of Life | Research Design - standards | Respiratory System Agents - adverse effects | Clinical Trials as Topic - methods | Clinical Trials as Topic - standards | Bronchiectasis - physiopathology
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8. Full Text Consensus Statement on Diagnostic End Points for Infant Tuberculosis Vaccine Trials
by Mark Hatherill and Suzanne Verver and Hassan Mahomed and Taskforce Clinical Res Issues Stop and Taskforce on Clinical Research Issues, Stop TB Partnership Working Group on TB Vaccines and the Taskforce on Clinical Research Issues, Stop TB Partnership Working Group on TB Vaccines
Clinical Infectious Diseases, ISSN 1058-4838, 2/2012, Volume 54, Issue 4, pp. 493 - 501
Background. Definition of clinical trial end points for childhood tuberculosis is hindered by lack of a standard case definition. We aimed to identify areas of... 
Phenotypes | Tuberculosis | Meningeal tuberculosis | Mycobacterium tuberculosis | Vaccination | Pulmonary tuberculosis | Radiology | Tuberculosis vaccine | Children | ARTICLES AND COMMENTARIES | Epidemiology | INFECTIOUS DISEASES | EFFICACY | PREVENTION | PRE-CHEMOTHERAPY ERA | MICROBIOLOGY | CALMETTE-GUERIN VACCINATION | IMMUNOLOGY | CHILDREN | VARIABILITY | INDUCED SPUTUM | CHILDHOOD PULMONARY TUBERCULOSIS | GASTRIC LAVAGE | BCG VACCINATION | HIV Infections - immunology | Humans | Tuberculosis - prevention & control | BCG Vaccine - immunology | Biomarkers | Infant | BCG Vaccine - administration & dosage | Estonia | Babies | Genotype & phenotype | Immunization | Infectious diseases | Clinical trials | Vaccines | Index Medicus
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9. Full Text Effectiveness End Points in Real-World Studies on Biological Therapies in Psoriasis: Systematic Review with Focus on Drug Survival
by Costanzo, Antonio and Malara, Giovanna and Pelucchi, Claudio and Fatiga, Francesco and Barbera, Giovanna and Franchi, Andrea and Galeone, Carlotta
Dermatology, ISSN 1018-8665, 07/2018, Volume 234, Issue 1-2, pp. 1 - 12
Psoriasis is a complex and chronic disease, and, in most cases, therapies are required during all patients’ lifetime. The efficacy and safety profiles of... 
IDEOM - Review Paper | Effectiveness | Psoriasis review | Drug survival | Epidemiology | Real-world evidence | TO-SEVERE PSORIASIS | FAILURE RATES | CLINICAL-EXPERIENCE | DERMATOLOGY | LONGITUDINAL ASSESSMENT | CHRONIC PLAQUE PSORIASIS | TREATMENT PATTERNS | MEDICATION COMPLIANCE | ETANERCEPT | BRITISH ASSOCIATION | LONG-TERM EFFICACY | Psoriasis - drug therapy | Humans | Dermatologic Agents - therapeutic use | Infliximab - therapeutic use | Dermatologic Agents - adverse effects | Ustekinumab - therapeutic use | Patient Satisfaction | Adalimumab - therapeutic use | Medication Adherence | Time Factors | Endpoint Determination | Biological Products - adverse effects | Biological Products - therapeutic use | Etanercept - therapeutic use | Index Medicus
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10. Full Text Evolution of Clinical Trials for Irritable Bowel Syndrome: Issues in End Points and Study Design
by Trentacosti, Ann Marie and He, Ruyi and Burke, Laurie B and Griebel, Donna and Kennedy, Dianne L
The American Journal of Gastroenterology, ISSN 0002-9270, 04/2010, Volume 105, Issue 4, pp. 731 - 735
Irritable bowel syndrome (IBS) involves a broad range of physiological and psychological alterations that may affect brain-gut dysregulation, gut function,... 
EFFICACY | TEGASEROD | DOUBLE-BLIND | DRUG DEVELOPMENT | STOOL FORM | ALOSETRON | SYMPTOM RELIEF | 5-HT3 RECEPTOR ANTAGONIST | PLACEBO-CONTROLLED TRIAL | GASTROENTEROLOGY & HEPATOLOGY | IMMPACT RECOMMENDATIONS | Guidelines as Topic | Irritable Bowel Syndrome - therapy | Irritable Bowel Syndrome - diagnosis | United States | Humans | Treatment Outcome | Clinical Trials as Topic | Research Design | United States Food and Drug Administration | Index Medicus
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11. Full Text Safety and efficacy of cerebral protection devices in transcatheter aortic valve replacement: A clinical end-points meta-analysis
by Mohananey, Divyanshu and Sankaramangalam, Kesavan and Kumar, Arnav and Jobanputra, Yash and Villablanca, Pedro and Krishnaswamy, Amar and Mick, Stephanie and Svensson, Lars G and Tuzcu, E. Murat and Kapadia, Samir R
Cardiovascular Revascularization Medicine, ISSN 1553-8389, 10/2018, Volume 19, Issue 7, pp. 785 - 791
Stroke after transcatheter aortic valve replacement (TAVR) occurs with an incidence of 4–11% and is a particularly devastating adverse event associated with... 
Stroke | Cerebral embolic protection | Safety and efficacy | TAVR | Transcatheter Aortic Valve Replacement - instrumentation | Predictive Value of Tests | Stroke - prevention & control | Risk Assessment | Stroke - diagnostic imaging | Humans | Risk Factors | Treatment Outcome | Aortic Valve Stenosis - mortality | Incidence | Protective Factors | Intracranial Embolism - diagnostic imaging | Diffusion Magnetic Resonance Imaging | Embolic Protection Devices | Aortic Valve Stenosis - surgery | Intracranial Embolism - prevention & control | Stroke - mortality | Transcatheter Aortic Valve Replacement - mortality | Intracranial Embolism - mortality | Transcatheter Aortic Valve Replacement - adverse effects | Stroke (Disease) | Heart valve diseases | Health aspects | Mortality | Cardiovascular agents
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12. Full Text FDA and EMA end points: which outcome end points should we use in clinical trials in patients with irritable bowel syndrome?
by Corsetti, M and Tack, J
Neurogastroenterology & Motility, ISSN 1350-1925, 06/2013, Volume 25, Issue 6, pp. 453 - 457
Trial design and endpoints for the evaluation of drug efficacy in irritable bowel syndrome ( IBS ) underwent major changes over the last two decades. A... 
adequate relief | irritable bowel syndrome | patient reported outcome | European Medicines Agency | Food and Drug Administration | Patient reported outcome | Adequate relief | Irritable bowel syndrome | RANDOMIZED CONTROLLED-TRIALS | CONSTIPATION | LINACLOTIDE | EFFICACY | SAFETY | NEUROSCIENCES | CLINICAL NEUROLOGY | IBS-C | EVALUATE | GASTROENTEROLOGY & HEPATOLOGY | United States | Europe | Humans | Endpoint Determination | Gastrointestinal Agents - therapeutic use | Irritable Bowel Syndrome - drug therapy | Treatment Outcome | Constipation - drug therapy | Abdominal Pain - drug therapy | United States Food and Drug Administration | Clinical trials | Patient outcomes | Bowel disease | Index Medicus
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13. Full Text Surrogate End Points and FDA Approval: A Tale of 2 Lipid-Altering Drugs
by Psaty, Bruce M and Lumley, Thomas
JAMA, ISSN 0098-7484, 03/2008, Volume 299, Issue 12, pp. 1474 - 1476
For new drugs to treat conditions, the US Food and Drug Administration generally uses their treatment effects on the level of the risk factors to evaluate them... 
MEDICINE, GENERAL & INTERNAL | ESTER TRANSFER PROTEIN | MYOCARDIAL-INFARCTION | EFFICACY | SAFETY | CHOLESTEROL ABSORPTION INHIBITOR | PRIMARY HYPERCHOLESTEROLEMIA | TORCETRAPIB | RISK | ROSIGLITAZONE | EZETIMIBE | Azetidines - therapeutic use | United States | Humans | Ezetimibe | Biomarkers | Risk | Clinical Trials as Topic | Drug Approval | Hypolipidemic Agents - therapeutic use | Quinolines - therapeutic use | United States Food and Drug Administration | Drugs | Clinical trials | Government agencies | FDA approval | Index Medicus | Abridged Index Medicus
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14. Full Text Biomarkers, Risk Factors, and Risk: Clarifying the Controversy about Surrogate End Points and Clinical Outcomes
by Krumholz, Harlan M
Circulation: Cardiovascular Quality and Outcomes, ISSN 1941-7713, 09/2015, Volume 8, Issue 5, pp. 457 - 459
LDL CHOLESTEROL | CARDIAC & CARDIOVASCULAR SYSTEMS | METAANALYSIS | RANDOMIZED-TRIALS | EFFICACY | STATIN THERAPY | SAFETY | TARGETS | PARTICIPANTS | United States - epidemiology | Cardiovascular Diseases - metabolism | Risk Assessment | Humans | Risk Factors | Biomarkers - analysis | Cardiovascular Diseases - therapy | Endpoint Determination - methods | Cardiovascular Diseases - epidemiology | Disease Management | Morbidity | Index Medicus
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15. New drugs and patient-centred end-points in old age: Setting the wheels in motion
by Mangoni, Arduino A and Pilotto, Alberto
Expert Review of Clinical Pharmacology, ISSN 1751-2433, 01/2016, Volume 9, Issue 1, pp. 81 - 89
Older patients with various degrees of frailty and disability, a key population target of pharmacological interventions in acute and chronic disease states,... 
frailty | functional status | pharmacodynamics | safety | therapeutic goals | drug development | older adults | pharmacokinetics | efficacy | MULTIDIMENSIONAL PROGNOSTIC INDEX | ADULTS | COGNITIVE IMPAIRMENT | COMPREHENSIVE GERIATRIC ASSESSMENT | BLOOD-PRESSURE | ALL-CAUSE MORTALITY | PHARMACOLOGY & PHARMACY | PEOPLE | TERM MORTALITY | POLYPHARMACY
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16. End points in irritable bowel syndrome
by Mangel, Allen W and Fehnel, Sheri E
Expert Review of Gastroenterology and Hepatology, ISSN 1747-4124, 06/2011, Volume 5, Issue 3, pp. 293 - 295
patient-reported outcomes | bowel function | end point | irritable bowel syndrome | urgency | ADEQUATE RELIEF | TRIALS | CONSTIPATION | DESIGN | EFFICACY | SAFETY | ALOSETRON | 5-HT3 RECEPTOR ANTAGONIST | PAIN | GASTROENTEROLOGY & HEPATOLOGY
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17. Full Text Causal inference for definitive clinical end points in a randomized clinical trial with intervening nonrandomized treatments
by Korn, Edward L and Freidlin, Boris
Journal of Clinical Oncology, ISSN 0732-183X, 08/2010, Volume 28, Issue 24, pp. 3800 - 3802
PHASE-III TRIAL | EFFICACY | ONCOLOGY | CANCER | RENAL-CELL CARCINOMA | Prognosis | Randomized Controlled Trials as Topic - methods | Humans | Risk Factors | Kaplan-Meier Estimate | Transplantation, Autologous | Treatment Outcome | Antineoplastic Agents - therapeutic use | Models, Statistical | Stem Cell Transplantation | Disease-Free Survival | Neuroblastoma - drug therapy | Neuroblastoma - surgery | Causality | Research Design | Index Medicus
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18. Full Text Randomized, placebo-controlled, phase IV pilot study of ramosetron to evaluate the co-primary end points in male patients with irritable bowel syndrome with diarrhea
by Ida, Motoko and Nishida, Akito and Akiho, Hiraku and Nakashima, Yoshihiro and Matsueda, Kei and Fukudo, Shin
BioPsychoSocial Medicine, ISSN 1751-0759, 03/2017, Volume 11, Issue 1, pp. 8 - 8
Background: Global assessment allows patients to assess improvement in multiple irritable bowel syndrome (IBS) symptoms. However, it was deemed important to... 
Abdominal pain | Abdominal discomfort | Stool consistency | Global improvement | 5-hydroxytryptamine (5-HT) | EFFICACY | PSYCHIATRY | ALOSETRON | DISORDERS | SYMPTOMS | PREVALENCE | RECEPTOR ANTAGONIST RAMOSETRON | PSYCHOLOGY, MULTIDISCIPLINARY | 5-HT3 RECEPTOR | QUALITY-OF-LIFE | IBS | INDUCED DEFECATION | Pain | Motility | Intestine | Irritable bowel syndrome | Gastroenterology | Diarrhea | Clinical trials | Product development | FDA approval | Patients | Drug dosages | Abdomen
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