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Challenges in translating endpoints from trials to observational cohort studies in oncology

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Challenges in translating endpoints from trials to observational cohort studies in oncology. / Ording, Anne Gulbech; Cronin Fenton, Deirdre; Ehrenstein, Vera; Lash, Timothy L; Acquavella, John Francis; Rørth, Mikael; Sørensen, Henrik Toft.

In: Clinical epidemiology, Vol. 8, 2016, p. 195-200.

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@article{bc055acf353248f98e6df33489506949,
title = "Challenges in translating endpoints from trials to observational cohort studies in oncology",
abstract = "Clinical trials are considered the gold standard for examining drug efficacy and for approval of new drugs. Medical databases and population surveillance registries are valuable resources for post-approval observational research, which are increasingly used in studies of benefits and risk of new cancer drugs. Here, we address the challenges in translating endpoints from oncology trials to observational studies. Registry-based cohort studies can investigate real-world safety issues - including previously unrecognized concerns - by examining rare endpoints or multiple endpoints at once. In contrast to clinical trials, observational cohort studies typically do not exclude real-world patients from clinical practice, such as old and frail patients with comorbidity. The observational cohort study complements the clinical trial by examining the effectiveness of interventions applied in clinical practice and by providing evidence on long-term clinical outcomes, which are often not feasible to study in a clinical trial. Various endpoints can be included in clinical trials, such as hard endpoints, soft endpoints, surrogate endpoints, and patient-reported endpoints. Each endpoint has it strengths and limitations for use in research studies. Endpoints used in oncology trials are often not applicable in observational cohort studies which are limited by the setting of standard clinical practice and by non-standardized endpoint determination. Observational studies can be more helpful moving research forward if they restrict focus to appropriate and valid endpoints.",
keywords = "Journal Article, Review",
author = "Ording, {Anne Gulbech} and {Cronin Fenton}, Deirdre and Vera Ehrenstein and Lash, {Timothy L} and Acquavella, {John Francis} and Mikael R{\o}rth and S{\o}rensen, {Henrik Toft}",
year = "2016",
doi = "10.2147/CLEP.S97874",
language = "English",
volume = "8",
pages = "195--200",
journal = "Clinical Epidemiology",
issn = "1179-1349",
publisher = "Dove Medical Press Ltd.(Dovepress)",

}

RIS

TY - JOUR

T1 - Challenges in translating endpoints from trials to observational cohort studies in oncology

AU - Ording, Anne Gulbech

AU - Cronin Fenton, Deirdre

AU - Ehrenstein, Vera

AU - Lash, Timothy L

AU - Acquavella, John Francis

AU - Rørth, Mikael

AU - Sørensen, Henrik Toft

PY - 2016

Y1 - 2016

N2 - Clinical trials are considered the gold standard for examining drug efficacy and for approval of new drugs. Medical databases and population surveillance registries are valuable resources for post-approval observational research, which are increasingly used in studies of benefits and risk of new cancer drugs. Here, we address the challenges in translating endpoints from oncology trials to observational studies. Registry-based cohort studies can investigate real-world safety issues - including previously unrecognized concerns - by examining rare endpoints or multiple endpoints at once. In contrast to clinical trials, observational cohort studies typically do not exclude real-world patients from clinical practice, such as old and frail patients with comorbidity. The observational cohort study complements the clinical trial by examining the effectiveness of interventions applied in clinical practice and by providing evidence on long-term clinical outcomes, which are often not feasible to study in a clinical trial. Various endpoints can be included in clinical trials, such as hard endpoints, soft endpoints, surrogate endpoints, and patient-reported endpoints. Each endpoint has it strengths and limitations for use in research studies. Endpoints used in oncology trials are often not applicable in observational cohort studies which are limited by the setting of standard clinical practice and by non-standardized endpoint determination. Observational studies can be more helpful moving research forward if they restrict focus to appropriate and valid endpoints.

AB - Clinical trials are considered the gold standard for examining drug efficacy and for approval of new drugs. Medical databases and population surveillance registries are valuable resources for post-approval observational research, which are increasingly used in studies of benefits and risk of new cancer drugs. Here, we address the challenges in translating endpoints from oncology trials to observational studies. Registry-based cohort studies can investigate real-world safety issues - including previously unrecognized concerns - by examining rare endpoints or multiple endpoints at once. In contrast to clinical trials, observational cohort studies typically do not exclude real-world patients from clinical practice, such as old and frail patients with comorbidity. The observational cohort study complements the clinical trial by examining the effectiveness of interventions applied in clinical practice and by providing evidence on long-term clinical outcomes, which are often not feasible to study in a clinical trial. Various endpoints can be included in clinical trials, such as hard endpoints, soft endpoints, surrogate endpoints, and patient-reported endpoints. Each endpoint has it strengths and limitations for use in research studies. Endpoints used in oncology trials are often not applicable in observational cohort studies which are limited by the setting of standard clinical practice and by non-standardized endpoint determination. Observational studies can be more helpful moving research forward if they restrict focus to appropriate and valid endpoints.

KW - Journal Article

KW - Review

U2 - 10.2147/CLEP.S97874

DO - 10.2147/CLEP.S97874

M3 - Journal article

VL - 8

SP - 195

EP - 200

JO - Clinical Epidemiology

JF - Clinical Epidemiology

SN - 1179-1349

ER -