Details
| Translated title of the contribution | Measuring health related quality of life in lung cancer clinical trials - Anoverview of the database ClinicalTrials.gov: An Overview of the Database ClinicalTrials.gov |
|---|---|
| Original language | Multiple languages |
| Pages (from-to) | 3-15 |
| Number of pages | 13 |
| Journal | PharmacoEconomics - German Research Articles |
| Volume | 10 |
| Issue number | 1 |
| Publication status | Published - Mar 2012 |
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.
ASJC Scopus subject areas
- Economics, Econometrics and Finance(all)
- Economics, Econometrics and Finance (miscellaneous)
- Pharmacology, Toxicology and Pharmaceutics(all)
- Pharmacology, Toxicology and Pharmaceutics (miscellaneous)
Sustainable Development Goals
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In: PharmacoEconomics - German Research Articles, Vol. 10, No. 1, 03.2012, p. 3-15.
Research output: Contribution to journal › Review article › Research › peer review
}
TY - JOUR
T1 - Lebensqualitätsmessung in klinischen Studien beim Lungenkarzinom
T2 - Übersicht anhand der Datenbank ClinicalTrials.gov
AU - Damm, Kathrin
AU - Jacob, Christian
AU - Mittendorf, Thomas
AU - Von Der Schulenburg, J. Matthias Graf
PY - 2012/3
Y1 - 2012/3
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=84859084998&partnerID=8YFLogxK
U2 - 10.1007/BF03320774
DO - 10.1007/BF03320774
M3 - Review article
AN - SCOPUS:84859084998
VL - 10
SP - 3
EP - 15
JO - PharmacoEconomics - German Research Articles
JF - PharmacoEconomics - German Research Articles
SN - 1612-3727
IS - 1
ER -