324:
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607:(ORR). The FDA definition of ORR in this context is "the proportion of patients with tumor size reduction of a predefined amount and for a minimum time period." Another criterion is the clinical benefit rate (CBR), "the total number (or percentage) of patients who achieved a complete response, partial response, or had stable disease for 6 months or more".
589:, or death. An example of a cancer study powered for a combined endpoint is disease-free survival; trial participants experiencing either death or discovery of any recurrence would constitute the endpoint. Overall Treatment Utility is an example of a multidimensional composite endpoint in cancer clinical trials.
545:), by taking action such as killing the animal humanely, terminating a painful procedure, or giving treatment to relieve pain and/or distress. The occurrence of an individual in a trial having reached may necessitate withdrawal from the trial before the target outcome of interest has been fully reached.
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Unlike overall survival, which is based on death from any cause or the condition being treated, the toxic death rate picks up just the deaths that are directly attributable to the treatment itself. These rates are generally low to zero as clinical trials are typically halted when toxic deaths occur.
450:
rather than death. The people who relapse are still surviving but they are no longer disease-free. Just as in the survival curves not all patients die, in "disease-free survival curves" not all patients relapse and the curve may have a final plateau representing the patients who didn't relapse after
249:
In a general sense, a clinical endpoint is included in the entities of interest in a trial. The results of a clinical trial generally indicate the number of people enrolled who reached the pre-determined clinical endpoint during the study interval compared with the overall number of people who were
476:
The response duration is occasionally used to analyze the results of the treatment for the advanced disease. The event is progression of the disease (relapse). This endpoint involves selecting a subgroup of the patients. It measures the length of the response in those patients who responded. The
531:
Important medical events (IME) that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the
269:
as a clinical endpoint. Any patient enrolled in the trial who develops chest pain over the course of the trial, then, would be counted as having reached that clinical endpoint. The results would ultimately reflect the fraction of patients who reached the endpoint of having developed chest pain,
642:
Various studies on a particular topic often do not address the same outcomes, making it difficult to draw clinically useful conclusions when a group of studies is looked at as a whole. The Core
Outcomes in Women's Health (CROWN) Initiative is one effort to standardize outcomes.
277:, the proportion of individuals who reach the clinical endpoint after an intervention is compared with the proportion of individuals in the control group who reached the same clinical endpoint, reflecting the ability of the intervention to prevent the endpoint in question.
170:
are trial endpoints that have outcomes that substitute for a clinical endpoint, often because studying the clinical endpoint is difficult, for example using an increase in blood pressure as a surrogate for death by cardiovascular disease, where strong evidence of a
423:, death from any cause, or death from disease. A cancer study may be powered for overall survival, usually indicating time until death from any cause, or disease-specific survival, where the endpoint is death from disease or death from toxicity.
1003:
849:; Downing, Gregory J; Ellenberg, Susan S; Friedman, Lawrence; Gail, Mitchell H; Prentice, Ross; Wittes, Janet; Zeger, Scott L (October 2001). "Considerations in the Evaluation of Surrogate Endpoints in Clinical Trials".
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is usually used in analysing the results of the treatment for the advanced disease. The event for the progression free survival is that the disease gets worse or progresses, or the patient dies from any cause.
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Regarding humane endpoints, a combined endpoint may constitute a threshold where there is enough cumulative degree of disease, symptoms, signs or laboratory abnormalities to motivate an intervention.
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The disease free survival is usually used to analyze the results of the treatment for the localized disease which renders the patient apparently disease free, such as surgery or surgery plus
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the study's maximum follow-up. Because the patients survive for at least some time after the relapse, the curve for the actual survival would look better than disease free survival curve.
925:
Handforth, C.; Hall, P.; Marshall, H.; Seymour, M. (October 2013). "Overall treatment utility: A novel outcome measure to convey the balance of benefits and harms from cancer treatment".
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Overall survival is based on death from any cause, not just the condition being treated, thus it picks up death from side effects of the treatment, and effects on survival after relapse.
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415:, discovery of distant metastasis, onset of symptoms, hospitalization, increase or decrease in pain medication requirement, onset of toxicity, requirement of salvage
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The response rate is the percentage of patients on whom a therapy has some defined effect; for example, the cancer shrinks or disappears after treatment.
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as a measure that will be considered success of the therapy being trialled (e.g. in justifying a marketing approval). The primary endpoint might be a
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A humane endpoint can be defined as the point at which pain and/or distress is terminated, minimized or reduced for an entity in a trial (such as an
145:. The term may also refer to any disease or sign that strongly motivates withdrawal of an individual or entity from the trial, then often termed a
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enrolled. Once a patient reaches the endpoint, he or she is generally excluded from further experimental intervention (the origin of the term
623:
802:
Biomarkers
Definitions Working Group (March 2001). "Biomarkers and surrogate endpoints: Preferred definitions and conceptual framework".
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1438:
581:, which can merge a variety of outcomes into one group. For example, the heart attack study above may report the incidence of the
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The percentage of treated patients experiencing one or more serious adverse events. Serious adverse events are defined by the US
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is used so that the trial endpoint can be calculated once 50% of subjects have reached the endpoint, whereas calculation of an
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700:"A systemic review of Toxic Death in clinical oncology trials: an Achilles' heel in safety reporting revisited"
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Persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions
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Clinical endpoints can be obtained from different modalities, such as behavioural or cognitive scores, or
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Spiegelhalter, David J.; Abrams, Keith R.; Myles, Jonathan P. (2004). "Randomised
Controlled Trials".
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Even with chemotherapy the overall rate is typically under a percent. However, the lack of systematic
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1030:"The CROWN Initiative: journal editors invite researchers to develop core outcomes in women's health"
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569:(USA) define surrogate endpoint as "a biomarker intended to substitute for a clinical endpoint".
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are additional endpoints, preferably also pre-specified, for which the trial may not be powered.
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618:(PR) to the therapy or intervention. Hence the trials report the complete response rate and the
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Guidance for
Industry Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics
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Penninckx, B; Van de Voorde, W M; Casado, A; Reed, N; Moulin, C; Karrasch, M (26 June 2012).
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These are expressed as a period of time (survival duration) e.g., in months. Frequently the
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When used as a clinical endpoint for trials of cancer treatments, this is often called the
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From
Netherlands Association for Laboratory Animal Science (NVP). Retrieved April 2011.
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is a similar endpoint that ignores patients who die before the disease progresses.
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as "Any AE occurring at any dose that results in any of the following outcomes:
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Each trial, for whatever illness or condition, may define what is considered a
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clinical endpoint but doesn't necessarily have a guaranteed relationship. The
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Objective tumor response and RECIST criteria in cancer clinical trials
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Inpatient hospitalization or prolongation of existing hospitalization
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Bayesian
Approaches to Clinical Trials and Health-Care Evaluation
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This article incorporates text from this source, which is in the
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can only be done after all subjects have reached the endpoint.
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For example, a clinical trial investigating the ability of a
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Core
Outcomes in Women's Health (CROWN) Initiative (2014).
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of a clinical trial is the endpoint for which the trial is
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or laboratory abnormality constituting a target outcome in
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Endpoints: How the
Results of Clinical Trials are Measured
419:, requirement of salvage surgery, requirement of salvage
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1085:. Chichester: John Wiley & Sons. pp. 181–249.
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limits our understanding of deaths due to treatments.
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compared with the overall number of people enrolled.
46:. Unsourced material may be challenged and removed.
1004:"Understanding a Cancer Research Study | OncoLink"
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1102:"The Clinical Side: Clinical trial endpoints"
577:Some studies will examine the incidence of a
446:. In the disease-free survival, the event is
748:"CFR - Code of Federal Regulations Title 21"
624:Response evaluation criteria in solid tumors
477:patients who don't respond aren't included.
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296:(OS). A trial might also define one or more
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217:. Unsourced material may be challenged and
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372:Learn how and when to remove this message
237:Learn how and when to remove this message
106:Learn how and when to remove this message
1443:Preventable fraction among the unexposed
1439:Attributable fraction for the population
804:Clinical Pharmacology & Therapeutics
517:Life-threatening adverse drug experience
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1447:Preventable fraction for the population
1435:Attributable fraction among the exposed
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845:De Gruttola, Victor G; Clax, Pamela;
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1610:Correlation does not imply causation
1526:Animal testing on non-human primates
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622:which includes CR and PR. (See e.g.
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532:outcomes listed in this definition."
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350:adding citations to reliable sources
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215:adding citations to reliable sources
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44:adding citations to reliable sources
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886:"Introduction to Surrogate Markers"
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632:Immune-related response criteria
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310:that are less likely to be met.
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1100:Chin, Jane Y. (1 August 2004).
1034:Journal of Gynecologic Oncology
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527:Congenital anomaly/birth defect
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1215:Patient and public involvement
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677:NCI Dictionary of Cancer Terms
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628:Small-cell carcinoma treatment
502:Percent serious adverse events
273:When an experiment involves a
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1106:Pharmaceutical Representative
927:Journal of Geriatric Oncology
863:10.1016/S0197-2456(01)00153-2
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567:National Institutes of Health
404:, or biochemical biomarkers.
1620:Sex as a biological variable
884:Cohn, J. N. (29 June 2004).
679:. National Cancere Institute
653:Multiple comparisons problem
508:Food and Drug Administration
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1584:Intention-to-treat analysis
1556:Analysis of clinical trials
1485:Specificity and sensitivity
1239:Randomized controlled trial
896:(25 suppl 1): IV–20–IV-21.
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630:, and for immunotherapies,
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129:referring to occurrence of
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851:Controlled Clinical Trials
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957:National Cancer Institute
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704:British Journal of Cancer
673:"median overall survival"
461:Progression Free Survival
455:Progression free survival
303:progression-free-survival
290:statistically significant
1195:Academic clinical trials
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143:clinical research trials
1413:Relative risk reduction
1261:Adaptive clinical trial
1205:Evidence-based medicine
1188:Adaptive clinical trial
816:10.1067/mcp.2001.113989
605:objective response rate
1401:Number needed to treat
752:www.accessdata.fda.gov
390:Electroencephalography
1405:Number needed to harm
1292:Cross-sectional study
1244:Scientific experiment
1200:Clinical study design
620:overall response rate
587:myocardial infarction
438:Disease free survival
308:exploratory endpoints
1371:Cumulative incidence
716:10.1038/bjc.2012.252
346:improve this section
211:improve this section
40:improve this article
1278:Observational study
1210:Real world evidence
1164:experimental design
543:experimental animal
466:Time to Progression
298:secondary endpoints
168:Surrogate endpoints
162:Secondary endpoints
55:"Clinical endpoint"
1680:Medical statistics
1564:Risk–benefit ratio
1531:First-in-man study
1481:Case fatality rate
1322:Case–control study
1296:Longitudinal study
1112:on 5 October 2011.
788:2010-08-27 at the
555:surrogate endpoint
549:Surrogate endpoint
119:Clinical endpoints
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1605:Survivorship bias
1569:Systematic review
1536:Multicenter trial
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1489:Likelihood-ratios
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1429:Population impact
1383:Period prevalence
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