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clinical trial

Notes: - a control group for comparison with an experimental or study group forms the basis for data analysis [9] - positive results of pharmaceutical trials tend to be published - negative results of pharmaceutical trials tend not to be published or to tend to be published in a manner that portrays a positive effect, often conflicting with FDA's analysis [6] - this may lead to clinicians overestimating efficacy of drugs. - only ~75% of completed trials listed in www.clinicaltrials.gov are published (online or in print) [10] - U.S. Department of Health and Human Services on proposed new rules that would expand the number of clinical trials that companies and researchers are required to report - new rule would expand the reporting requirements to include all trials of unapproved, unlicensed, and uncleared products - second proposal would also require the publication of all clinical trials funded by the NIH [11] - expanded recommendations for open data access [12,13,14]

Specific

A Study to Evaluate the Effect of Rosuvastatin on Intravascular Ultrasound-Derived Coronary Atheroma Burden (ASTEROID) Action to Control Cardiovascular Risk in Diabetes (ACCORD trial) ACTION trial ADVANCE trial Advanced Cognitive Training for Independent & Vital Elderly (ACTIVE) study Age-Related Eye Disease Study (AREDS) Air Force/Texas Coronary Atherosclerosis Prevention (AFCAPS/TexCAPS) study Alzheimer's Disease Anti-inflammatory Prevention Trial (ADAPT) Alzheimer's Disease Cooperative Study (ADCS) Arterial Revascularization Therapy Study (ARTS) ASCOT clinical trial ASPEN study asymptomatic carotid artery stenosis (ACAS) study ATHENA study Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events (ACTIVE A,W,I) trial Atrial Fibrillation Follow-up Investigator of Rhythm Management (AFFIRM) Atrial Fibrillation Suppression Trial (AFIST) atypical vs conventional antipsychotics in the elderly BOOST study (stem cell infusion for MI) Breast Cancer Detection Demonstration Project Bronchitis Randomized on NAC Cost-Utility Study (BRONCUS) Bypass Angioplasty Revascularization Investivation (BARI) CAMELOT study Canadian amiodarone myocardial infarction arrhythmia trial (CAMIAT) Canadian support groups for patients with metastatic breast cancer study CAPRIE study CARDIA study cardiac arrhythmia supression trial (CAST) cardiovascular risk factors, aging, & dementia (CAIDE) trial CEA vs CAS (CREST) trial CHAMPS clinical trial CHARISMA trial CHARM program (clinical trials) Cholesterol & Recurrent Events (CARE) study CLARICOR trial Clinical Antipsychotic Trials in Intervention Effectiveness (CATIE) clinical trial memantine + cholinesterase inhibitor clinical trials, non-small-cell lung cancer CLOpidogrel & Metoprolol in Myocardial Infarction Trial (COMMIT) Collaborative Atorvastatin Diabetes Study (CARDS) Combined Angiolasty & Pharmacologic Intervention versus Thromboylisis ALone in Acute Mycocardial Infarction (CAPITAL AMI) study combined estrogen plus bisphosphonate congestive heart failure survival trial of antiarrhythmic therapy (CHF-STAT) Cooperate clinical trial cross-over study Diabetes Control & Complications Trial (DCCT) Diabetes REduction Assessment with ramipril & rosiglitazone Medication (DREAM) study digoxin investigation group (DIG) trial DNASCO study Dutch Randomized Endovascular Aneurysm Management trial (DREAM trial) E-SIRIUS trial Early Treatment of Diabetic Retinopathy Study (ETDRS) ELITE II Study Endovascular Aneurysm Repair (EVAR) trial ENHANCE trial ENTER trial ESCHAR study ESPRIT Study ESPS-2 study European myocardial infarction amiodarone trial (EMIAT) EURopean trial On reduction of cardiac events with Perinopril in stable coronary Artery disease (EUROPA) trial Evaluation study of congestive heart failure & pulmonary artery catheterization effectiveness( ESCAPE) EVEREST trial exercise rehabilitation trial (EXERT) ezetimibe add-on to statin for effectiveness (EASE) trial FACTT study Field study finasteride prophylaxis study Fosamax Actonel Comparison Trial Frailty & Injuries: Cooperative Studies of Intervention Techniques (FICSIT) study galantamine clinical trials GESICA study glargine clinical trial Global Registry of Acute Coronary Events (GRACE) study Guide study Health, Aging & Body Composition Study Heart & Estrogen/Progestin Replacement Study (HERS) Heart Outcomes Prevention Evaluation (HOPE) Heart Outcomes Prevention Evaluation (HOPE) Study Herbal Alternatives for Menopause (HALT) study HOPE & HOPE Too trials HOPE-2 trial HOPE-3 trial hormone replacement after breast cancer diagnosis-is it safe? (HABITS) trial Huperzine A study hypertension clinical trials ICTUS trial Incremental Decrease in Endpoints through Aggressive Lipid-lowering (IDEAL) trial INSPIRE trial International subarachnoid Aneurysm Trial (ISAT) ISAR-REACT 2 trial ischemic stroke prevention trial Kronos Early Estrogen Prevention Study (KEEPS) Management of Elevated Cholesterol in the Primary Prevention Group of Adult Japanese (Mega Study) MATCH study memantine clinical trials Memory Impairment Study Million Women Study Modification of diet in Renal Disease (MDRD) Study Montelukast Study of Asthma in children (MOSAIC) MORE-CORE trial multicenter automatic defibrillator implantation trial (MADIT) National Emphysema Treatment Trial Navigator study NIH Glucosamine/Chondroitin Arthritis Intervention Trial (GAIT) North American Symptomatic Carotid Endarterectomy Trial (NASCET) Nurses' Health Study Organization to Assess Strategies in Acute Ischemic Syndrome (OASIS) trial (OASIS-5, OASIS-6) Pac-Man study Pacemaker Selection in the Elderly (PASE) study PEACE study Periscope trial PLATO study POEMS trial Post Menopausal Estrogen/Progestin Intervention trial (PEPI) Prevail trial Prevent Recurrence of Osteoporotic Fracture (PROOF) Study PREVENT trial Prevention of REStinosis with Tranilast & its Outcomes (PRESTO) trial Prevention of Suicide in Primary Care Elderly: Collaborative Trial (PROSPECT) Prevention of Syncope Trial (POST) Prevention Regimen For Effectively avoiding Second Strokes (PRoFESS) study primary care management module primary prevention project (PPP) project ECHO Proscar Long-Term Efficacy and Safety Study (PLESS) Prospective Investigation Of Pulmonary Embolism Diagnosis (PIOPED) study Prospective Study of Pravastatin in Elderly People at Risk (PROSPER) prostate cancer outcomes PROVE-IT study Randomized ALdactone Evaluation Study (RALES) randomized clinical trial; randomized controlled trial (RCT) React trial REIN-2 clinical trial Reversal of Atherosclerosis with Aggressive Lipid Lowering [REVERSAL] study RIO-North America study RITA trial (includes RITA-3) SAFE study Sequenced Treatment Alternatives to Relieve Depression (STAR*D) SHARP study Should We Emergently Revascularize Occluded Coronaries for Cardiogenic Shock (SHOCK) trial SOLVD prevention trial statin clinical trials Strategies for Management of Antiretroviral Therapy (SMART) study stroke prevention & atrial fibrillation trial Study of Tamoxifen And Raloxifene (STAR) SU.VLMAX study Surgical Trial In Intracerebral Hemorrhage (STICH) Syncope Evaluation in the Emergency Department Study (SEEDS) SYNERGY trial Syntax trial TACTICS-TIMI trial Therapeutic Arthritis Research & Gastrointestinal Event Trial (TARGET) TICORA study TIMI study Tiotropium: Influence on the Perception of the Improvement in Routine Activities Objectified by a Numerical Scale (TIPHON) trial of infant response to diphenhydramine (TIRED study) Understanding Potential Long-Term Impacts on Function with Tiotropium (UPLIFT) study United Kingdom back pain exercise and manipulation (UK BEAM) randomised trial United Kingdom Prospective Diabetes Study (UKPDS) unnamed randomized controlled trial VALsartan in Acute myocardial iNfarcTion (VALIANT) trial VALUE trial VANQWISH trial Veterans Affairs Diabetes Trial (VADT) VIGOR trial Warfarin Aspirin Recurrent Stroke Study (WARSS) Warfarin-Aspirin Symptomatic Intracranial Disease (WASID) trial Which Early ST elevation myocardial infarction Therapy (WEST) study Women's Health Initiative (WHI) Women's Health Initiative: Antihypertensives and Cardiovascular Death Women's Health Initiative: Dietary Modification Trial Womens Health Initiative (WHI) memory study

General

experimental study human subjects research

References

  1. http://www.clinicaltrials.gov
  2. Applying Study Results to Patient Care: Glossary of Study Design and Statistical Terms Prescriber's Letter 11(5):25 2004 Prescriber's Letter 11(7):37 2004 (updated chart) Detail-Document#: 200715 (subscription needed) http://www.prescribersletter.com
  3. Prescriber's Letter 11(10): 2004 Worksheet to Evaluate Drug Studies Detail-Document#: 201012 (subscription needed) http://www.prescribersletter.com
  4. Prescriber's Letter 12(5): 2005 Worksheet to Evaluate Drug Studies Detail-Document#: 210610 (subscription needed) http://www.prescribersletter.com
  5. Junghans C et al, Recruiting patients to medical research: Double blind ramdomized trial of 'opt-in' vs 'opt-out' strategies. BMJ 331:940, 2005 PMID: 16157604
  6. Turner EH et al, Selective publication of antidepressant trials and its influence on apparent efficacy. N Engl J Med 2008, 358:252 PMID: 18199864
  7. McCormack J, Greenhalgh T. Seeing what you want to see in randomised controlled trials: versions and perversions of UKPDS data. United Kingdom prospective diabetes study. BMJ. 2000 Jun 24;320(7251):1720-3. PMID: 10864554
  8. Trotta F, Apolone G, Garattini S, Tafuri G. Stopping a trial early in oncology: for patients or for industry? Ann Oncol. 2008 Apr 9. [Epub ahead of print] PMID: 18304961 http://dx.doi.org/doi:10.1093/annonc/mdn042
  9. Ho PM, Peterson PN, Masoudi FA Evaluating the evidence: is there a rigid hierarchy? Circulation. 2008 Oct 14;118(16):1675-84 PMID: 18852378
  10. Jones CW et al. Non-publication of large randomized clinical trials: Cross sectional analysis. BMJ 2013 Oct 29; 347:f6104 PMID: 24169943 http://www.bmj.com/content/347/bmj.f6104
  11. National Institutes of Health. News & Events. Nov. 19, 2014 HHS and NIH take steps to enhance transparency of clinical trial results. http://www.nih.gov/news/health/nov2014/od-19.htm
  12. Institute of Medicine. Jan 14, 2015 Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. http://www.iom.edu/Reports/2015/Sharing-Clinical-Trial-Data.aspx - Drazen JM Sharing Individual Patient Data from Clinical Trials. N Engl J Med 2015; 372:201-202. January 15, 2015 PMID: 25587944 http://www.nejm.org/doi/full/10.1056/NEJMp1415160
  13. Taichman DB et al Sharing Clinical Trial Data - A Proposal from the International Committee of Medical Journal Editors. N Engl J Med. January 20, 2016 PMID: 26786954 http://www.nejm.org/doi/full/10.1056/NEJMe1515172
  14. Haug CJ From Patient to Patient - Sharing the Data from Clinical Trials. N Engl J Med. May 10, 2016 Perspective PMID: 27168009 http://www.nejm.org/doi/full/10.1056/NEJMp1605378
  15. The Yoda project Yale University Open Data Access http://yoda.yale.edu/
  16. van Delden JJ, van der Graaf R Revised CIOMS International Ethical Guidelines for Health- Related Research Involving Humans. JAMA. Published online December 6, 2016 PMID: 27923072 http://jamanetwork.com/journals/jama/fullarticle/2592245
  17. Tinetti ME. The gap between clinical trials and the real world: extrapolating treatment effects from younger to older adults. JAMA Intern Med. 2014 Mar;174(3):397-8. PMID: 24424303
  18. Tatsioni A, Karassa FB, Goodman SN et al. Lost evidence from registered large long-unpublished randomized controlled trials: A survey. Ann Intern Med 2019 May 7; PMID: 31060046 https://annals.org/aim/article-abstract/2732839/lost-evidence-from-registered-large-long-unpublished-randomized-controlled-trials - Wallach JD, Krumholz HM. Not reporting results of a clinical trial is academic misconduct. Ann Intern Med 2019 May 7; PMID: 31060050 https://annals.org/aim/article-abstract/2732840/reporting-results-clinical-trial-academic-misconduct