Predicting Harms and Benefits in Translational Trials: Ethics,
Evidence, and Uncertainty
article has not abstract
Vyšlo v časopise:
Predicting Harms and Benefits in Translational Trials: Ethics,
Evidence, and Uncertainty. PLoS Med 8(3): e32767. doi:10.1371/journal.pmed.1001010
Kategorie:
Essay
prolekare.web.journal.doi_sk:
https://doi.org/10.1371/journal.pmed.1001010
Souhrn
article has not abstract
Zdroje
1. KimmelmanJ
2010
Gene transfer and the ethics of first-in-human research: lost in
translation.
Cambridge
Cambridge University Press
2. ExtanceA
2010
Alzheimer's failure raises questions about disease-modifying
strategies.
Nat Rev Drug Discov
9
749
751
3. The National Commission for the Protection of Human Subjects of
Biomedical and Behavioural Research
1979
The Belmont report: ethical principles and guidelines for the
protection of human subjects of research.
Bethesda
Department of Health Education and Welfare
4. World Medical Association
1964
Declaration of Helsinki.
Helsinki
18th World Medical Assembly
5. MannH
2010
ASSERT: a standard for the review and monitoring of randomized
clinical trials.
Available: http://www.assert-statement.org/. Accessed 31 January
2011
6. Department of Health and Human Services
2005
Protection of human subjects: criteria for IRB approval of
research.
Title 45 CFR 46.111(a)(1)
1
12
7. LondonAJKimmelmanJEmborgME
2010
Research ethics. Beyond access vs. protection in trials of
innovative therapies.
Science
328
829
830
8. DjulbegovicBKumarASoaresHPHozoIBeplerG
2008
Treatment success in cancer: new cancer treatment successes
identified in phase 3 randomized controlled trials conducted by the National
Cancer Institute-sponsored cooperative oncology groups, 1955 to
2006.
Arch Intern Med
168
632
642
9. KumarASoaresHWellsRClarkeMHozoI
2005
Are experimental treatments for cancer in children superior to
established treatments? Observational study of randomised controlled trials
by the Children's Oncology Group.
BMJ
331
1295
10. SoaresHPKumarADanielsSSwannSCantorA
2005
Evaluation of new treatments in radiation oncology: are they
better than standard treatments?
JAMA
293
970
978
11. GrossCPKrumholzHMVan WyeGEmanuelEJWendlerD
2006
Does random treatment assignment cause harm to research
participants?
PLoS Med
3
e188
doi:10.1371/journal.pmed.0030188
12. KolaILandisJ
2004
Can the pharmaceutical industry reduce attrition
rates?
Nat Rev Drug Discov
3
711
715
13. PangalosMNSchechterLEHurkoO
2007
Drug development for CNS disorders: strategies for balancing risk
and reducing attrition.
Nat Rev Drug Discov
6
521
532
14. Contopoulos-IoannidisDGNtzaniEIoannidisJP
2003
Translation of highly promising basic science research into
clinical applications.
Am J Med
114
477
484
15. van der WorpHBHowellsDWSenaESPorrittMJRewellS
2010
Can animal models of disease reliably inform human
studies?
PLoS Med
7
e1000245
doi:10.1371/journal.pmed.1000245
16. KilkennyCParsonsNKadyszewskiEFestingMFCuthillIC
2009
Survey of the quality of experimental design, statistical
analysis and reporting of research using animals.
PLoS ONE
4
e7824
doi:10.1371/journal.pone.0007824
17. ReynoldsJCRittenbergerJCMenegazziJJ
2007
Drug administration in animal studies of cardiac arrest does not
reflect human clinical experience.
Resuscitation
74
13
26
18. BathPMGrayLJBathAJBuchanAMiyataT
2009
Effects of NXY-059 in experimental stroke: an individual animal
meta-analysis.
Br J Pharmacol
157
1157
1171
19. PhilipMBenatarMFisherMSavitzSI
2009
Methodological quality of animal studies of neuroprotective
agents currently in phase II/III acute ischemic stroke
trials.
Stroke
40
577
581
20. SenaESvan der WorpHBBathPMHowellsDWMacleodM
2010
Publication bias in reports of animal stroke studies leads to
major overstatement of efficacy.
PLoS Biol
8
e1000344
doi:10.1371/journal.pbio.1000344
21. MacleodMRFisherMO'CollinsVESenaESDirnaglU
2009
Good laboratory practice. Preventing introduction of bias at the
bench.
Stroke
40
e50
e52
22. KilkennyCBrowneWCuthillIEmersonMAltmanD
2010
Improving bioscience research reporting: the ARRIVE guidelines
for reporting animal research.
PLoS Biol
8
e1000412
doi:10.1371/journal.pbio.1000412
23. HenleyDBMayPCDeanRASiemersER
2009
Development of semagacestat (LY450139), a functional
gamma-secretase inhibitor, for the treatment of Alzheimer's
disease.
Expert Opin Pharmacother
10
1657
1664
24. American Society of Clinical Oncology
1997
Critical role of phase I clinical trials in cancer
treatment.
J Clin Oncol
15
853
859
25. ChristianMShoemakerD
2002
The investigator's handbook: a manual for participants in
clinical trials of investigational agents sponsored by DCTD,
NCI.
Bethesda
Cancer Therapy Evaluation Program
26. International Conference on Harmonisation of Technical Requirements for
Registration of Pharmaceuticals for Human Use (ICH)
1996
ICH Harmonized Tripartite Guideline.
Guideline for Good Clinical Practice E6(R1)
27. LowensteinPR
2008
A call for physiopathological ethics.
Mol Ther
16
1771
1772
28. IoannidisJPKarassaFB
2010
The need to consider the wider agenda in systematic reviews and
meta-analyses: breadth, timing, and depth of the evidence.
BMJ
341
c4875
29. MangialascheFSolomonAWinbladBMecocciPKivipeltoM
2010
Alzheimer's disease: clinical trials and drug
development.
Lancet Neurol
9
702
716
30. CummingsJ
2010
What can be inferred from the interruption of the semagacestat
trial for treatment of Alzheimer's disease?
Biol Psychiatry
68
876
878
31. HoldenC
2009
Neuroscience. Fetal cells again?
Science
326
358
359
32. KimmelmanJLondonAJRavinaBRamsayTBernsteinM
2009
Launching invasive, first-in-human trials against
Parkinson's disease: ethical considerations.
Mov Disord
24
1893
1901
33. LindvallOKokaiaZ
2010
Stem cells in human neurodegenerative disorders—time for
clinical translation?
J Clin Invest
120
29
40
34. AndersonJAKimmelmanJ
2010
Extending clinical equipoise to phase 1 trials involving
patients: unresolved problems.
Kennedy Inst Ethics J
20
75
98
35. GilmanSKollerMBlackRSJenkinsLGriffithSG
2005
Clinical effects of Abeta immunization (AN1792) in patients with
AD in an interrupted trial.
Neurology
64
1553
1562
36. FeldmanHHDoodyRSKivipeltoMSparksDLWatersDD
2010
Randomized controlled trial of atorvastatin in mild to moderate
Alzheimer disease: LEADe.
Neurology
74
956
964
37. Elan Corporation
2010
Elan and Transition Therapeutics announce topline summary results
of Phase 2 study and plans for Phase 3 for ELND005 (Scyllo-inositol)
[press release]
38. SallowaySSperlingRGilmanSFoxNCBlennowK
2009
A phase 2 multiple ascending dose trial of bapineuzumab in mild
to moderate Alzheimer disease.
Neurology
73
2061
2070
39. WinbladBGiacobiniEFrolichLFriedhoffLTBruinsmaG
2010
Phenserine efficacy in Alzheimer's disease.
J Alzheimers Dis
22
1201
1208
40. GoldMAldertonCZvartau-HindMEggintonSSaundersAM
2010
Rosiglitazone monotherapy in mild-to-moderate alzheimer's
disease: results from a randomized, double-blind, placebo-controlled phase
III study.
Dement Geriatr Cogn Disord
30
131
146
41. GreenRCSchneiderLSAmatoDABeelenAPWilcockG
2009
Effect of tarenflurbil on cognitive decline and activities of
daily living in patients with mild Alzheimer disease: a randomized
controlled trial.
JAMA
302
2557
2564
42. Bellus Health Inc
2008
Neurochem announces results from Tramiprosate (ALZHEMED(TM))
North American Phase III clinical trial
43. MarksWJJrBartusRTSiffertJDavisCSLozanoA
2010
Gene delivery of AAV2-neurturin for Parkinson's disease: a
double-blind, randomised, controlled trial.
Lancet Neurol
9
1164
1172
44. NuttJBurchielKJComellaCLJankovicJLangAE
2003
Randomized, double-blind trial of glial cell line-derived
neurotrophic factor (GDNF) in PD.
Neurology
60
69
73
45. LangAEGillSPatelNKLozanoANuttJG
2006
Randomized controlled trial of intraputamenal glial cell
line-derived neurotrophic factor infusion in Parkinson
disease.
Ann Neurol
59
459
466
46. FreedCRGreenePEBreezeRETsaiWYDuMouchelW
2001
Transplantation of embryonic dopamine neurons for severe
Parkinson's disease.
N Engl J Med
344
710
719
47. OlanowCWGoetzCGKordowerJHStoesslAJSossiV
2003
A double-blind controlled trial of bilateral fetal nigral
transplantation in Parkinson's disease.
Ann Neurol
54
403
414
48. WattsRLFreemanTBHauserRABakayRAEElliasSA
2001
A double-blind, randomised, controlled, multicenter clinical
trial of the safety and efficacy of stereotaxic intrastriatal implantation
of fetal porcine ventral mesencephalic tissue (Neurocelli-PD) vs. imitation
surgery in patients with Parkinson's disease (PD).
Parkinsonism Relat Disord
7
Suppl
S87
49. OlanowCWSternMBSethiK
2009
The scientific and clinical basis for the treatment of Parkinson
disease.
Neurology
72
21 Suppl 4S1
S136
Štítky
Interné lekárstvoČlánok vyšiel v časopise
PLOS Medicine
2011 Číslo 3
- Statiny indukovaná myopatie: Jak na diferenciální diagnostiku?
- MUDr. Dana Vondráčková: Hepatopatie sú pri liečbe metamizolom väčším strašiakom ako agranulocytóza
- Vztah mezi statiny a rizikem vzniku nádorových onemocnění − metaanalýza
- Nech brouka žít… Ať žije astma!
- Parazitičtí červi v terapii Crohnovy choroby a dalších zánětlivých autoimunitních onemocnění
Najčítanejšie v tomto čísle
- The BCG World Atlas: A Database of Global BCG Vaccination Policies and Practices
- How Can Institutional Review Boards Best Interpret Preclinical Data?
- The Challenge of Discharging Research Ethics Duties in Resource-Constrained Settings
- HIV-1 Drug Resistance Emergence among Breastfeeding Infants Born to HIV-Infected Mothers during a Single-Arm Trial of Triple-Antiretroviral Prophylaxis for Prevention of Mother-To-Child Transmission: A Secondary Analysis