28:
114:
trial continue. It is extremely unlikely that the trial, should it continue to its normal end, would have the statistical evidence needed to convince a regulatory agency to approve the treatment. The company sponsoring the study could save money for other projects by abandoning this trial. Also, current and potential trial participants could be freed to take other treatments, rather than this experimental treatment, which is unlikely to benefit them.
83:. The DMC will convene at predetermined intervals (depending on the type of study) to review unblinded results. The DMC has the power to recommend continuation or termination of the study based on the evaluation of these results. There are typically three reasons a DMC might recommend termination of the study: safety concerns, outstanding benefit, and futility.
71:– no one involved with the trial knows what treatment is to be given to each trial participant. Blinding includes the participant, their doctor, and even the study personnel at the company or organization sponsoring the trial. Blinding is breached and true assignments disclosed only after the trial database is finalized.
95:
of a particularly serious type are more common in the experimental arm compared to the control arm, then the DMC would have to strongly consider termination of the study. This evaluation has to be made in consideration of risk/benefit. In many cases, the experimental arm could cause serious adverse
74:
Clinical trials may test an unknown procedure or may continue for years, and there is justifiable concern about enrolling participants and exposing them to an unproven treatment without ongoing oversight of the preliminary results. The DMC is a group (typically 3 to 7 members) who are independent of
104:
In the fortunate situation that the experimental arm is shown to be undeniably superior to the control arm, the DMC may recommend termination of the trial. This would allow the company sponsoring the trial to get regulatory approval earlier and to allow the superior treatment to get to the patient
113:
Futility is not as widely recognized as safety and benefit, but actually can be the most common reason to stop a trial. As an example, suppose a trial is one-half completed, but the experimental arm and the control arm have nearly identical results. It's likely in no one's interest to have this
79:. Clinicians knowledgeable about the disease indication should be represented, as well as clinicians knowledgeable in the fields of any major suspected safety effects. Ethicists or representatives from a patient advocacy group may be included, particularly for research involving
105:
population earlier. There are cautions here, though. The statistical evidence needs to be very high indeed. Also, there might be other reasons to continue, such as collecting more long-term safety data.
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1001:
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1015:
691:
489:
138:
27:
810:
64:
748:
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576:
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421:
96:
events (chemotherapy, for example), but the resulting improvement in survival outweighs these adverse events.
836:
794:
772:
742:
642:
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123:
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703:
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372:
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673:
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51:) – is an independent group of experts who monitor patient safety and treatment efficacy data while a
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332:
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510:
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17:
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286:
858:
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416:
276:
266:
892:
267:
Establishment and
Operation of Clinical Trial Data Monitoring Committees
897:
385:
195:
Data
Monitoring Committees in Clinical Trials: A Practical Perspective
75:
the entity conducting the trial. At least one DMC member will be a
193:
Ellenberg, Susan S.; Fleming, Thomas R.; DeMets, David L. (2019).
26:
91:
The primary mandate of the DMC is to protect patient safety. If
514:
290:
170:
Data
Monitoring Committees (DMCs): Past, Present, and Future
224:
Data
Monitoring in Clinical Trials: A Case Studies Approach
222:
DeMets, David; Furberg, Curt; Friedman, Lawrence (2006).
243:
Data and Safety
Monitoring Committees in Clinical Trials
277:
Use of Data
Monitoring Committees in Clinical Trials
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269:Guidance for clinical trial sponsors by the
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31:An early recipient of the COVID-19 vaccine
168:Rawat, Nand Kishore; Kerr, David (2023).
825:Preventable fraction among the unexposed
821:Attributable fraction for the population
829:Preventable fraction for the population
817:Attributable fraction among the exposed
160:
437:Guidelines for human subject research
7:
992:Correlation does not imply causation
908:Animal testing on non-human primates
25:
348:Privacy for research participants
45:data and safety monitoring board
875:Pre- and post-test probability
597:Patient and public involvement
1:
477:Monitoring in clinical trials
279:Guidance for industry by the
144:Monitoring in clinical trials
1002:Sex as a biological variable
445:List of medical ethics cases
281:Food and Drug Administration
271:Food and Drug Administration
18:Data safety monitoring board
966:Intention-to-treat analysis
938:Analysis of clinical trials
867:Specificity and sensitivity
621:Randomized controlled trial
1078:
490:Institutional review board
139:Institutional review board
65:randomized clinical trials
1010:
975:Interpretation of results
708:Nested case–control study
495:Data monitoring committee
37:data monitoring committee
1057:Clinical data management
577:Academic clinical trials
500:Community advisory board
422:Clinical research ethics
795:Relative risk reduction
643:Adaptive clinical trial
587:Evidence-based medicine
570:Adaptive clinical trial
455:Declaration of Helsinki
197:(2nd ed.). Wiley.
124:Clinical trial protocol
43:) – sometimes called a
783:Number needed to treat
373:Human subject research
283:(Draft, February 2024)
245:. Chapman & Hall.
81:vulnerable populations
32:
787:Number needed to harm
674:Cross-sectional study
626:Scientific experiment
582:Clinical study design
30:
753:Cumulative incidence
318:Research participant
241:Herson, Jay (2009).
100:Overwhelming benefit
660:Observational study
592:Real world evidence
546:experimental design
343:Respect for persons
1062:Medical monitoring
946:Risk–benefit ratio
913:First-in-man study
863:Case fatality rate
704:Case–control study
678:Longitudinal study
33:
1052:Clinical research
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1038:
987:Survivorship bias
951:Systematic review
918:Multicenter trial
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871:Likelihood-ratios
843:Clinical endpoint
811:Population impact
765:Period prevalence
542:Clinical research
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507:
381:Clinical research
358:Return of results
353:Right to withdraw
252:978-1-420-07037-8
233:978-0-387-20330-0
204:978-1-119-51265-3
179:978-3-031-28759-6
149:Pharmacovigilance
16:(Redirected from
1069:
886:Trial/test types
761:Point prevalence
739:
682:Ecological study
665:EBM II-2 to II-3
636:Open-label trial
631:Blind experiment
607:Controlled study
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485:Ethics committee
363:Informed consent
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803:Hazard ratio
687:Cohort study
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459:
273:(March 2006)
242:
226:. Springer.
223:
194:
188:
172:. Springer.
169:
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112:
103:
90:
77:statistician
73:
69:double-blind
62:
55:is ongoing.
48:
44:
40:
36:
34:
997:Null result
956:Replication
851:Infectivity
773:Association
724:Case report
714:Case series
697:Prospective
467:Common Rule
333:Beneficence
1046:Categories
799:Odds ratio
791:Risk ratio
757:Prevalence
743:Occurrence
719:Case study
155:References
859:Morbidity
847:Virulence
749:Incidence
417:Bioethics
1023:Glossary
1016:Category
893:In vitro
734:Measures
553:Overview
118:See also
109:Futility
898:In vivo
386:Biobank
338:Justice
326:Rights
320:rights
249:
230:
201:
176:
837:Other
63:Many
676:vs.
544:and
247:ISBN
228:ISBN
199:ISBN
174:ISBN
67:are
49:DSMB
41:DMC
1048::
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