941:
1317:
1124:
1200:
858:
852:
1193:
846:
1186:
1139:
971:
404:
1172:
986:
919:
1244:
1016:
1353:
1292:
701:
1347:
904: – the first clinical trial to demonstrate that statin therapy may provide benefit to patients with low-to-normal LDL levels and no known cardiovascular disease.
1359:
1340:
688:
677:
464:
1289: – defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records.
1415:
1280:
1167:
1421:
835:
889:
880: – a cardiovascular study based in Framingham, Massachusetts, which began in 1948 with 5,209, and is now on its third generation of participants.
1520:
1633:
1427:
409:
1295:(HIPAA) – Title II of HIPAA addresses the security and privacy of health data, including data collected from subjects in clinical research.
922: – a clinical study, conducted between 1932 and 1972 in Tuskegee, Alabama studied the natural progression of the disease if left untreated.
619:
81: – the technological application that uses biological systems, living organisms to make or modify products or processes for specific use
1412: – as head of the Food and Drug Administration, the commissioner reports to the Secretary of the Department of Health and Human Services
913:
666:
1330:
1256:
966:
841:
706:
1144:
1026:
1424: – responsible for review and approval of medical devices and safety of non-medical equipment that emit certain types of radiation
1473:
1369:
557:
1628:
1418: – responsible for review and approval of biologic products, including vaccines, blood products, gene therapy and human cloning
1277: – allows the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process.
419:
201:
1464:
1446:
1386:
1380:
1096:
481:
898: – a landmark observational study that showed a strong association between dietary salt and risk of cardiovascular disease.
1375:
1031:
981:
599:
1493:
1409:
1274:
551:
322:
1597:
1592:
1587:
1582:
1577:
1572:
1567:
1562:
1557:
1552:
1547:
1540:
1529:
135: – the study of the interactions that occur between a living organism and drugs that alter normal biochemical function
1488:
907:
540:
476:
1449: – allows an investigational device to be used in a clinical study in order to collect safety and effectiveness data
1513:
1433:
1398:
1260:
1162:
1021:
733:
518:
1455: – allows an investigational drug to be used in a clinical study in order to collect safety and effectiveness data
1086:
1079:
825:
783:
763:
723:
717:
535:
357:
1318:
International
Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
916: – a controlled study of the effects of malaria on the inmates of Stateville Penitentiary near Joliet, Illinois.
69: – the identification of candidates, synthesis, characterization, screening, and assays for therapeutic efficacy
1618:
1364:
508:
444:
414:
362:
347:
778:
1335:
1266:
1134:
1129:
998:
976:
830:
651:
588:
332:
205:
1452:
1069:
629:
604:
352:
98:
1269: – requires drug manufacturers to provide proof of the effectiveness and safety of drugs before approval.
892: – four randomized controlled trials of several drugs for treating suspected acute myocardial infarction.
874: – in 1956 provided convincing statistical proof that tobacco smoking increased the risk of lung cancer.
101: – clinical trials run at academic centers (e.g., medical schools, academic hospitals, and universities)
75: – the process of taking a new chemical through the stages necessary to allow testing in clinical trials
1506:
1305:
793:
614:
609:
498:
126:
118:
1623:
991:
883:
877:
753:
645:
486:
434:
388:
292:
129: – the assessment of the quality of evidence relevant to the risks and benefits of medical treatments
952:
886: – the largest study to investigate the use of statins in the prevention of cardiovascular disease.
871:
748:
530:
459:
394:
302:
261:
144:
60:
147: – the scientific discipline focused on rational drug development and utilization in therapeutics
1458:
1286:
1229:
1224:
1219:
1064:
225: – the practice of prescribing a drug for an indication for which the drug has not been approved
104:
219: – any substance or combination of substances used for treating or preventing disease in humans
1239:
1234:
337:
32:
1476: – a designation given to an NDA by the FDA that accelerates review and approval of new drugs
1461: – a submission to the FDA by a pharmaceutical company for review and approval of a new drug
1311:
808:
798:
439:
429:
317:
312:
287:
249:
63: – a conclusion that an intervention has an effect that is of practical meaning to patients
181: – the detection, assessment, understanding and prevention of adverse effects of medicines
1638:
1091:
948:
803:
788:
768:
634:
454:
327:
243:
216:
191:
178:
84:
40:
27:
1101:
1059:
594:
503:
342:
267:
164:
150:
72:
940:
910: – a study of over 6,000 men infected with HIV that has been ongoing for over 25 years
895:
820:
513:
307:
170:
138:
173: – the science of interpreting and describing pharmacology in a quantitative fashion
1074:
1049:
424:
232:
156:
92:
66:
44:
20:
1612:
1106:
901:
773:
743:
624:
399:
377:
372:
367:
222:
200: – a drug that has been approved for marketing by a regulatory body such as the
197:
78:
213: – an inactive substance used as a carrier for the active ingredients of a drug
1468:
738:
297:
246: – a licensed medicine that can only be obtained by prescription from a doctor
167: – the study of the biochemical and physiological effects of drugs on the body
132:
112:
1283: – the section of Federal regulations that interprets and enforces FD&C.
95: – an experiment with human subjects to assess safety and efficacy of drugs
1054:
728:
277:
272:
228:
758:
282:
115: – the study of factors affecting the health and illness of populations
572:
210:
252: – a currently available drug used in an active control clinical study
449:
107: – biomedical research units dedicated to conducting clinical trials
656:
567:
562:
237:
48:
23:
is provided as an overview of and topical guide to clinical research:
1498:
859:
Uniform
Requirements for Manuscripts Submitted to Biomedical Journals
672:
661:
577:
240: – a sham treatment given to a control group in a clinical study
853:
Strengthening the reporting of observational studies in epidemiology
847:
Preferred
Reporting Items for Systematic Reviews and Meta-Analyses
695:
159: – the biological equivalence of two preparations of a drug
153: – the study of the fate of drugs administered to the body
36:
1502:
194: – the substance in a drug that is pharmaceutically active
1263:(FDA) to oversee the safety of food, drugs, and cosmetics.
405:
231: – a drug used to treat a rare medical condition, or
1467: – a submission to the FDA review and approval of a
1430: – responsible for review and approval of all drugs
920:
Tuskegee Study of
Untreated Syphilis in the Negro Male
1245:
Directive 95/46/EC on the protection of personal data
934:
Regulation of therapeutic goods in the United States
1354:
Medicines and
Healthcare products Regulatory Agency
1293:
Health
Insurance Portability and Accountability Act
121: – statistical techniques used in epidemiology
16:Overview of and topical guide to clinical research
702:Standard for Exchange of Non-clinical Data (SEND)
1348:Federal Agency for Medicines and Health Products
1360:Ministry of Health, Labour and Welfare (Japan)
1341:Committee for Medicinal Products for Human Use
689:Clinical Data Interchange Standards Consortium
684:Clinical Data Interchange Standards Consortium
678:Common Terminology Criteria for Adverse Events
465:Suspected Adverse Reaction Surveillance Scheme
141: – the pharmacology of biopharmaceuticals
1514:
1194:
8:
1416:Center for Biologics Evaluation and Research
384:Study participant confidentiality and safety
1281:Title 21 of the Code of Federal Regulations
87: – a drug produced using biotechnology
1521:
1507:
1499:
1422:Center for Devices and Radiological Health
1394:United States Food and Drug Administration
1320:(European Union, Japan, and United States)
1201:
1187:
939:
930:
836:Consolidated Standards of Reporting Trials
1436: – enforces FDA laws and regulations
1259:(FD&C) – gives authority to the
890:International Studies of Infarct Survival
1428:Center for Drug Evaluation and Research
1017:Department of Health and Human Services
933:
410:Data confidentiality in clinical trials
927:Legislation, regulations and guidances
620:Good clinical data management practice
914:Stateville Penitentiary Malaria Study
667:Systematized Nomenclature of Medicine
35:that addresses the assessment of new
7:
1331:Australian Drug Evaluation Committee
1257:Federal Food, Drug, and Cosmetic Act
967:Federal Food, Drug, and Cosmetic Act
842:Electronic Common Technical Document
707:JANUS clinical trial data repository
1145:Single Convention on Narcotic Drugs
1474:FDA Fast Track Development Program
1370:State Food and Drug Administration
14:
420:Ethics Committee (European Union)
202:U.S. Food and Drug Administration
1465:Abbreviated New Drug Application
1447:Investigational Device Exemption
1387:Therapeutic Goods Administration
1381:Therapeutic Products Directorate
1097:Abbreviated New Drug Application
641:Medical term coding dictionaries
482:Clinical Trial Management System
1598:Technology and applied sciences
1376:Swedish Medical Products Agency
982:Prescription Drug Marketing Act
600:Clinical data management system
547:Contract research organizations
1634:Outlines of health and fitness
1494:List of biotechnology articles
1410:Commissioner of Food and Drugs
1275:Prescription Drug User Fee Act
1157:Non-governmental organizations
584:Data collection and management
552:Contract research organization
1:
1573:Natural and physical sciences
1489:Glossary of clinical research
908:Multicenter AIDS Cohort Study
694:Study Data Tabulation Model (
541:Clinical research coordinator
1441:Review and approval programs
1434:Office of Regulatory Affairs
1399:Food and Drug Administration
1261:Food and Drug Administration
1163:National Academy of Medicine
1022:Food and Drug Administration
734:End point of clinical trials
519:Standing operating procedure
1593:Society and social sciences
1588:Religion and belief systems
1087:Randomized controlled trial
826:Clinical trials publication
784:Sensitivity and specificity
764:Intention to treat analysis
724:Censoring (clinical trials)
718:Analysis of clinical trials
536:Clinical research associate
525:Clinical research personnel
493:Clinical research documents
358:Randomized controlled trial
1655:
1365:Norwegian Medicines Agency
1119:International coordination
445:Institutional review board
415:Data monitoring committees
363:Retrospective cohort study
348:Placebo-controlled studies
1536:
1336:European Medicines Agency
1267:Kefauver Harris Amendment
1130:Uppsala Monitoring Centre
999:Marihuana Tax Act of 1937
977:Controlled Substances Act
831:Common Technical Document
652:Uppsala Monitoring Centre
589:Clinical data acquisition
471:Clinical study management
333:Nested case-control study
206:European Medicines Agency
1629:Lists of research topics
1530:Knowledge (XXG) outlines
1453:Investigational New Drug
1070:Investigational New Drug
866:Notable clinical studies
630:Patient-reported outcome
605:Clinical data repository
353:Prospective cohort study
99:Academic clinical trials
1583:Philosophy and thinking
1306:Declaration of Helsinki
794:Substantial equivalence
615:Electronic data capture
610:Data clarification form
509:Investigator's brochure
499:Clinical trial protocol
127:Evidence-based medicine
119:Epidemiological methods
953:Over-the-counter drugs
884:Heart Protection Study
878:Framingham Heart Study
754:Number needed to treat
646:Medical classification
487:Good clinical practice
435:Great ape research ban
389:Human subject research
293:Clinical control group
1568:Mathematics and logic
1027:Department of Justice
872:British Doctors Study
779:Risk–benefit analysis
749:Number needed to harm
531:Clinical investigator
460:Serious adverse event
395:Adverse drug reaction
303:Cross-sectional study
262:Clinical study design
257:Types of study design
145:Clinical pharmacology
61:Clinical significance
1553:Geography and places
1548:Culture and the arts
1459:New Drug Application
1287:Title 21 CFR Part 11
1230:Directive 2005/28/EC
1225:Directive 2001/83/EC
1220:Directive 2001/20/EC
1065:New Drug Application
105:Clinical trials unit
1325:Government agencies
1240:Directive 93/41/EEC
1235:Directive 65/65/EEC
1102:Fast track approval
1011:Government agencies
477:Clinical monitoring
338:Observational study
33:biomedical research
1563:History and events
1558:Health and fitness
1312:Food and Drugs Act
949:Prescription drugs
809:Therapeutic effect
799:Surrogate endpoint
440:Inclusion criteria
430:Exclusion criteria
318:Longitudinal study
313:First-in-man study
288:Case-control study
250:Standard treatment
1619:Clinical research
1606:
1605:
1541:General reference
1211:
1210:
1092:Pharmacovigilance
815:Results reporting
804:Systematic review
789:Subgroup analysis
769:Post-hoc analysis
635:Remote data entry
455:Safety monitoring
328:Multicenter trial
244:Prescription drug
217:Medicinal product
192:Active ingredient
179:Pharmacovigilance
85:Biopharmaceutical
31:is the aspect of
28:Clinical research
1646:
1523:
1516:
1509:
1500:
1356:(United Kingdom)
1308:(United Nations)
1203:
1196:
1189:
1060:Drug development
987:Hatch-Waxman Act
943:
931:
595:Case report form
504:Informed consent
343:Open-label trial
268:Blind experiment
186:Drug terminology
165:Pharmacodynamics
151:Pharmacokinetics
73:Drug development
1654:
1653:
1649:
1648:
1647:
1645:
1644:
1643:
1609:
1608:
1607:
1602:
1578:People and self
1532:
1527:
1485:
1443:
1406:
1396:
1327:
1302:
1253:
1216:
1207:
1178:
1177:
1158:
1150:
1149:
1120:
1112:
1111:
1045:
1037:
1036:
1012:
1004:
1003:
962:
951:
929:
896:Intersalt study
868:
821:Medical writing
817:
715:
686:
643:
586:
549:
527:
514:Source document
495:
473:
386:
308:Crossover study
259:
188:
171:Pharmacometrics
139:Biopharmacology
57:
45:medical devices
17:
12:
11:
5:
1652:
1650:
1642:
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1636:
1631:
1626:
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1270:
1252:
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1248:
1247:
1242:
1237:
1232:
1227:
1222:
1215:
1214:European Union
1212:
1209:
1208:
1206:
1205:
1198:
1191:
1183:
1180:
1179:
1176:
1175:
1170:
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1114:
1113:
1110:
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1104:
1099:
1094:
1089:
1084:
1083:
1082:
1075:Clinical trial
1072:
1067:
1062:
1057:
1052:
1050:Drug discovery
1046:
1043:
1042:
1039:
1038:
1035:
1034:
1029:
1024:
1019:
1013:
1010:
1009:
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425:EudraVigilance
422:
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397:
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365:
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258:
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235:
233:orphan disease
226:
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214:
208:
195:
187:
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183:
182:
176:
175:
174:
168:
162:
161:
160:
157:Bioequivalence
148:
142:
130:
124:
123:
122:
110:
109:
108:
102:
93:Clinical trial
90:
89:
88:
76:
70:
67:Drug discovery
64:
56:
55:General topics
53:
37:pharmaceutical
19:The following
15:
13:
10:
9:
6:
4:
3:
2:
1651:
1640:
1637:
1635:
1632:
1630:
1627:
1625:
1624:Medical lists
1622:
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1251:United States
1250:
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1107:Off-label use
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903:
902:JUPITER trial
900:
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774:Relative risk
772:
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747:
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744:Meta-analysis
742:
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713:Data analysis
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625:Patient diary
623:
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579:
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400:Adverse event
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378:Vaccine trial
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373:Seeding trial
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368:Run-in period
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223:Off-label use
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198:Approved drug
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79:Biotechnology
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1469:generic drug
1397:
739:Hazard ratio
716:
687:
644:
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550:
387:
323:Minimisation
298:Cohort study
260:
133:Pharmacology
113:Epidemiology
26:
25:
18:
1404:Departments
1389:(Australia)
1055:Drug design
729:Effect size
278:Case series
273:Case report
229:Orphan drug
51:in humans.
1613:Categories
992:exemptions
759:Odds ratio
283:Case study
41:biological
1350:(Belgium)
838:(CONSORT)
573:Quintiles
211:Excipient
1639:Outlines
1483:See also
1383:(Canada)
1314:(Canada)
855:(STROBE)
849:(PRISMA)
669:(SNOMED)
450:MedWatch
49:vaccines
1372:(China)
1044:Process
657:COSTART
568:Parexel
563:Covance
238:Placebo
204:or the
43:drugs,
21:outline
1080:phases
972:CDAPCA
673:WHOART
662:MedDRA
578:Westat
1300:Other
1173:NORML
1168:RADAR
1140:CIOMS
861:(URM)
696:SDTM
47:and
39:and
1135:WHO
1125:ICH
1032:DEA
961:Law
558:PPD
1615::
1522:e
1515:t
1508:v
1202:e
1195:t
1188:v
698:)
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