Registration, results reporting, and publication bias of clinical trials supporting FDA approval of neuropsychiatric drugs before and after FDAAA: A retrospective cohort study

Trials

Volumn 19, Issue 1, 2018, Pages

  Zou, Constance X ^a   Becker, Jessica E ^b,c,d   Phillips, Adam T ^e   Garritano, James M ^a   Krumholz, Harlan M ^a,f,g   Miller, Jennifer E ^a   Ross, Joseph S ^a,f,g  

^a YALE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b MASSACHUSETTS GENERAL HOSPITAL   (United States)

^c MCLEAN HOSPITAL   (United States)

^d HARVARD MEDICAL SCHOOL   (United States)

^e BETH ISRAEL DEACONESS MEDICAL CENTER   (United States)

^f YALE UNIVERSITY   (United States)

^g YALE NEW HAVEN HOSPITAL   (United States)

Author keywords

Clinical trial registration; Clinical trial results; ClinicalTrials.gov; FDAAA; Publication bias; Selective publication

Indexed keywords

17 METHYLNALTREXONE; ASENAPINE; BOTULINUM TOXIN A; CAPSAICIN; CLOBAZAM; DESVENLAFAXINE; FAMPRIDINE; FINGOLIMOD; FOSPROPOFOL; GABAPENTIN ENACARBIL; ILOPERIDONE; LACOSAMIDE; LISDEXAMFETAMINE; LURASIDONE; MILNACIPRAN; NEUROLEPTIC AGENT; PALIPERIDONE; PERAMPANEL; RAMELTEON; RASAGILINE; RETIGABINE; ROTIGOTINE; RUFINAMIDE; TAPENTADOL; TERIFLUNOMIDE; TETRABENAZINE; UNINDEXED DRUG; VARENICLINE; VIGABATRIN; VILAZODONE; CENTRAL NERVOUS SYSTEM AGENTS;

ACT; ARTICLE; ATTENTION DEFICIT DISORDER; BIPOLAR I DISORDER; BLEPHAROSPASM; CERVICAL DYSTONIA; CLINICAL OUTCOME; CLINICAL TRIAL (TOPIC); COHORT ANALYSIS; COMPLEX PARTIAL SEIZURE; CONSTIPATION; CROSS-SECTIONAL STUDY; DRUG APPROVAL; DRUG EFFICACY; DRUG INDICATION; DRUG SURVEILLANCE PROGRAM; FIBROMYALGIA; FOCAL EPILEPSY; HUMAN; HUNTINGTON CHOREA; INSOMNIA; MAJOR DEPRESSION; MENTAL DISEASE; MULTIPLE SCLEROSIS; NEUROPATHIC PAIN; PAIN; PARKINSON DISEASE; PUBLICATION; PUBLISHING; REGISTRATION; RESTLESS LEGS SYNDROME; RETROSPECTIVE STUDY; RISK ASSESSMENT; SCHIZOPHRENIA; SEIZURE; STUDY DESIGN; SUBSTANCE USE; COMPARATIVE STUDY; FOOD AND DRUG ADMINISTRATION; MEASUREMENT ACCURACY; METHODOLOGY; PATHOPHYSIOLOGY; PROCEDURES; PSYCHOLOGY; REGISTER; TIME FACTOR; TREATMENT OUTCOME; UNITED STATES;

CENTRAL NERVOUS SYSTEM AGENTS; CLINICAL TRIALS AS TOPIC; DATA ACCURACY; DRUG APPROVAL; HUMANS; MENTAL DISORDERS; PUBLICATION BIAS; REGISTRIES; RESEARCH DESIGN; RETROSPECTIVE STUDIES; TIME FACTORS; TREATMENT OUTCOME; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 85055454548     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/s13063-018-2957-0     Document Type: Article

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