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618:(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".
600:, 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.
556:), 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.
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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
260:
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
487:
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
542:
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
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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,
653:
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.
288:, 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.
181:
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
434:, 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.
1014:
860:; 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.
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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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426:, 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
156:. 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
634:
813:
Biomarkers
Definitions Working Group (March 2001). "Biomarkers and surrogate endpoints: Preferred definitions and conceptual framework".
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592:, 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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711:"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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1041:"The CROWN Initiative: journal editors invite researchers to develop core outcomes in women's health"
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580:(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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629:(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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572:) is a measure of effect of a specific treatment that may correlate with a
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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
430:, requirement of salvage surgery, requirement of salvage
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1096:. 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.
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1015:"Understanding a Cancer Research Study | OncoLink"
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1113:"The Clinical Side: Clinical trial endpoints"
588:Some studies will examine the incidence of a
457:. In the disease-free survival, the event is
759:"CFR - Code of Federal Regulations Title 21"
635:Response evaluation criteria in solid tumors
488:patients who don't respond aren't included.
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307:(OS). A trial might also define one or more
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228:. Unsourced material may be challenged and
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383:Learn how and when to remove this message
248:Learn how and when to remove this message
117:Learn how and when to remove this message
1454:Preventable fraction among the unexposed
1450:Attributable fraction for the population
815:Clinical Pharmacology & Therapeutics
528:Life-threatening adverse drug experience
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1458:Preventable fraction for the population
1446:Attributable fraction among the exposed
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856:De Gruttola, Victor G; Clax, Pamela;
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1621:Correlation does not imply causation
1537:Animal testing on non-human primates
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633:which includes CR and PR. (See e.g.
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543:outcomes listed in this definition."
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361:adding citations to reliable sources
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226:adding citations to reliable sources
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55:adding citations to reliable sources
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897:"Introduction to Surrogate Markers"
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643:Immune-related response criteria
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321:that are less likely to be met.
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1111:Chin, Jane Y. (1 August 2004).
1045:Journal of Gynecologic Oncology
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1504:Pre- and post-test probability
1226:Patient and public involvement
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688:NCI Dictionary of Cancer Terms
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639:Small-cell carcinoma treatment
513:Percent serious adverse events
284:When an experiment involves a
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1117:Pharmaceutical Representative
938:Journal of Geriatric Oncology
874:10.1016/S0197-2456(01)00153-2
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578:National Institutes of Health
415:, or biochemical biomarkers.
1631:Sex as a biological variable
895:Cohn, J. N. (29 June 2004).
690:. National Cancere Institute
664:Multiple comparisons problem
519:Food and Drug Administration
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1595:Intention-to-treat analysis
1567:Analysis of clinical trials
1496:Specificity and sensitivity
1250:Randomized controlled trial
907:(25 suppl 1): IV–20–IV-21.
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641:, and for immunotherapies,
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140:referring to occurrence of
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158:humane (clinical) endpoint
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1337:Nested case–control study
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950:10.1016/j.jgo.2013.09.064
715:British Journal of Cancer
684:"median overall survival"
472:Progression Free Survival
466:Progression free survival
314:progression-free-survival
301:statistically significant
1206:Academic clinical trials
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154:clinical research trials
1424:Relative risk reduction
1272:Adaptive clinical trial
1216:Evidence-based medicine
1199:Adaptive clinical trial
827:10.1067/mcp.2001.113989
616:objective response rate
1412:Number needed to treat
763:www.accessdata.fda.gov
401:Electroencephalography
1416:Number needed to harm
1303:Cross-sectional study
1255:Scientific experiment
1211:Clinical study design
631:overall response rate
598:myocardial infarction
449:Disease free survival
319:exploratory endpoints
1382:Cumulative incidence
727:10.1038/bjc.2012.252
357:improve this section
222:improve this section
51:improve this article
1289:Observational study
1221:Real world evidence
1175:experimental design
554:experimental animal
477:Time to Progression
309:secondary endpoints
179:Surrogate endpoints
173:Secondary endpoints
66:"Clinical endpoint"
1691:Medical statistics
1575:Risk–benefit ratio
1542:First-in-man study
1492:Case fatality rate
1333:Case–control study
1307:Longitudinal study
1123:on 5 October 2011.
799:2010-08-27 at the
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1440:Population impact
1394:Period prevalence
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