Lebensqualitätsmessung in klinischen Studien beim Lungenkarzinom

Übersicht anhand der Datenbank ClinicalTrials.gov

verfasst von

Kathrin Damm, Christian Jacob, Thomas Mittendorf, J. Matthias Graf Von Der Schulenburg

Abstract

Background: In Germany, and throughout the world, the lung carcinoma is one of the most common and aggressive forms of cancer. Not only is the diagnosis itself stressful for the patients, but also the disease symptoms, such as (blood) cough, shortness of breath, pain in the chest and shoulders, in addition to the (toxic) side effects of therapies such as fatigue, weight loss, nausea, vomiting or diarrhea. While differences in clinical effectiveness decline, therapeutic alternatives must have a unique selling point. Accordingly, from the perspective of the industry, a stronger focus on patients quality of life is the consequence which is also requested by researchers and institutions. The aim of this study is to investigate whether a change in clinical research is taking place with reference to the inclusion of health related quality of life as an outcome measure in lung cancer trials and, if applicable, what instruments are used for this purpose. Methods: Using the ClinicalTrials.gov database, we conducted systematic research in late 2010. In particular we examined the quantity of lung cancer trials focusing on health related quality of life as well as on the instruments used. Comparisons were made over time (20052010). Results: "Overall survival" still prevails as the primary endpoint, whereas in clinical trials with biotechnology interventions the measurement of "progression-free survival" was claimed more often as the primary study endpoint. In approximately 10% of the trials "Quality of Life" is indicated as an endpoint. Lung cancer-specific questionnaires like the EORTC LC13, LCSS and FACT-L are most frequently used, sometimes in combination with the generic EQ-5D. Symptom-specific measurements are rare. Conclusions: A change in clinical research referring to the inclusion of health relatedquality of life as an outcome measure in lung cancer trials could not be found.

Organisationseinheit(en)

Institut für Versicherungsbetriebslehre

Externe Organisation(en)

Xcenda GmbH

Typ

Übersichtsarbeit

Journal

PharmacoEconomics - German Research Articles

Band

10

Seiten

3-15

Anzahl der Seiten

13

ISSN

1612-3727

Publikationsdatum

03.2012

Publikationsstatus

Veröffentlicht

Peer-reviewed

Ja

ASJC Scopus Sachgebiete

Volkswirtschaftslehre, Ökonometrie und Finanzen (sonstige), Pharmakologie, Toxikologie und Pharmazie (sonstige)

Ziele für nachhaltige Entwicklung

SDG 3 – Gute Gesundheit und Wohlergehen

Elektronische Version(en)

https://doi.org/10.1007/BF03320774 (Zugang: Geschlossen)