Clinical research in surgical oncology : an analysis of ClinicalTrials.gov
BACKGROUND: The objective of this study was to provide a descriptive analysis of registered clinical trials in surgical oncology at ClinicalTrials.gov.
METHODS: Data was extracted from ClinicalTrials.gov using the following search engine criteria: "Cancer" as Condition, "Surgery OR Operation OR Resection" as Intervention, and Non-Industry sponsored. The search was limited to Canada and the United States and included trials registered from January 1, 2001 to January 1, 2011.
RESULTS: Of 9,961 oncology trials, 1,049 (10.5%) included any type of surgical intervention. Of these trials, 125 (11.9%, 1.3% of all oncology trials) assessed a surgical variable, 773 (73.7%) assessed adjuvant/neoadjuvant therapies, and 151 (14.4%) were observational studies. Of the trials assessing adjuvant therapies, systemic treatment (362 trials, 46.8%) and multimodal therapy (129 trials, 16.7%) comprised a large focus. Of the 125 trials where surgery was the intervention, 59 trials (47.2%) focused on surgical techniques or devices, 45 trials (36.0%) studied invasive diagnostic methods, and 21 trials (16.8%) evaluated surgery versus no surgery. The majority of the 125 trials were nonrandomized (72, 57.6%).
CONCLUSIONS: The number of registered surgical oncology trials is small in comparison to oncology trials as a whole. Clinical trials specifically designed to assess surgical interventions are vastly outnumbered by trials focusing on adjuvant therapies. Randomized surgical oncology trials account for <1% of all registered cancer trials. Barriers to the design and implementation of randomized trials in surgical oncology need to be clarified in order to facilitate higher-level evidence in surgical decision-making.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2013 |
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| Erschienen: |
2013 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:20 |
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| Enthalten in: |
Annals of surgical oncology - 20(2013), 12 vom: 15. Nov., Seite 3725-31 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Menezes, Amber S [VerfasserIn] |
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| Links: |
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| Themen: |
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| Anmerkungen: |
Date Completed 05.06.2014 Date Revised 16.10.2013 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1245/s10434-013-3054-y |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM228652278 |
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| 100 | 1 | |a Menezes, Amber S |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Clinical research in surgical oncology |b an analysis of ClinicalTrials.gov |
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| 500 | |a Date Revised 16.10.2013 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a BACKGROUND: The objective of this study was to provide a descriptive analysis of registered clinical trials in surgical oncology at ClinicalTrials.gov | ||
| 520 | |a METHODS: Data was extracted from ClinicalTrials.gov using the following search engine criteria: "Cancer" as Condition, "Surgery OR Operation OR Resection" as Intervention, and Non-Industry sponsored. The search was limited to Canada and the United States and included trials registered from January 1, 2001 to January 1, 2011 | ||
| 520 | |a RESULTS: Of 9,961 oncology trials, 1,049 (10.5%) included any type of surgical intervention. Of these trials, 125 (11.9%, 1.3% of all oncology trials) assessed a surgical variable, 773 (73.7%) assessed adjuvant/neoadjuvant therapies, and 151 (14.4%) were observational studies. Of the trials assessing adjuvant therapies, systemic treatment (362 trials, 46.8%) and multimodal therapy (129 trials, 16.7%) comprised a large focus. Of the 125 trials where surgery was the intervention, 59 trials (47.2%) focused on surgical techniques or devices, 45 trials (36.0%) studied invasive diagnostic methods, and 21 trials (16.8%) evaluated surgery versus no surgery. The majority of the 125 trials were nonrandomized (72, 57.6%) | ||
| 520 | |a CONCLUSIONS: The number of registered surgical oncology trials is small in comparison to oncology trials as a whole. Clinical trials specifically designed to assess surgical interventions are vastly outnumbered by trials focusing on adjuvant therapies. Randomized surgical oncology trials account for <1% of all registered cancer trials. Barriers to the design and implementation of randomized trials in surgical oncology need to be clarified in order to facilitate higher-level evidence in surgical decision-making | ||
| 650 | 4 | |a Journal Article | |
| 700 | 1 | |a Barnes, Alison |e verfasserin |4 aut | |
| 700 | 1 | |a Scheer, Adena S |e verfasserin |4 aut | |
| 700 | 1 | |a Martel, Guillaume |e verfasserin |4 aut | |
| 700 | 1 | |a Moloo, Husein |e verfasserin |4 aut | |
| 700 | 1 | |a Boushey, Robin P |e verfasserin |4 aut | |
| 700 | 1 | |a Sabri, Elham |e verfasserin |4 aut | |
| 700 | 1 | |a Auer, Rebecca C |e verfasserin |4 aut | |
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