Randomized controlled trials in lung cancer surgery: How are we doing?Central MessagePerspective
Objective: Randomized control trials are considered the highest level of evidence, yet the scalability and practicality of implementing randomized control trials in the thoracic surgical oncology space are not well described. The aim of this study is to understand what types of randomized control tr...
| Main Authors: | , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2024-04-01
|
| Series: | JTCVS Open |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2666273624000093 |
| _version_ | 1797202985177055232 |
|---|---|
| author | Lye-Yeng Wong, MD Yanli Li, PhD Irmina A. Elliott, MD Leah M. Backhus, MD Mark F. Berry, MD Joseph B. Shrager, MD Daniel S. Oh, MD |
| author_facet | Lye-Yeng Wong, MD Yanli Li, PhD Irmina A. Elliott, MD Leah M. Backhus, MD Mark F. Berry, MD Joseph B. Shrager, MD Daniel S. Oh, MD |
| author_sort | Lye-Yeng Wong, MD |
| collection | DOAJ |
| description | Objective: Randomized control trials are considered the highest level of evidence, yet the scalability and practicality of implementing randomized control trials in the thoracic surgical oncology space are not well described. The aim of this study is to understand what types of randomized control trials have been conducted in thoracic surgical oncology and ascertain their success rate in completing them as originally planned. Methods: The ClinicalTrials.gov database was queried in April 2023 to identify registered randomized control trials performed in patients with lung cancer who underwent surgery (by any technique) as part of their treatment. Results: There were 68 eligible randomized control trials; 33 (48.5%) were intended to examine different perioperative patient management strategies (eg, analgesia, ventilation, drainage) or to examine different intraoperative technical aspects (eg, stapling, number of ports, port placement, ligation). The number of randomized control trials was relatively stable over time until a large increase in randomized control trials starting in 2016. Forty-four of the randomized control trials (64.7%) were open-label studies, 43 (63.2%) were conducted in a single facility, 66 (97.1%) had 2 arms, and the mean number of patients enrolled per randomized control trial was 236 (SD, 187). Of 21 completed randomized control trials (31%), the average time to complete accrual was 1605 days (4.4 years) and average time to complete primary/secondary outcomes and adverse events collection was 2125 days (5.82 years). Conclusions: Given the immense investment of resources that randomized control trials require, these findings suggest the need to scrutinize future randomized control trial proposals to assess the likelihood of successful completion. Future study is needed to understand the various contributing factors to randomized control trial success or failure. |
| first_indexed | 2024-04-24T08:12:08Z |
| format | Article |
| id | doaj.art-bafbae3c82674aee9a82359b69866970 |
| institution | Directory Open Access Journal |
| issn | 2666-2736 |
| language | English |
| last_indexed | 2024-04-24T08:12:08Z |
| publishDate | 2024-04-01 |
| publisher | Elsevier |
| record_format | Article |
| series | JTCVS Open |
| spelling | doaj.art-bafbae3c82674aee9a82359b698669702024-04-17T04:49:56ZengElsevierJTCVS Open2666-27362024-04-0118234252Randomized controlled trials in lung cancer surgery: How are we doing?Central MessagePerspectiveLye-Yeng Wong, MD0Yanli Li, PhD1Irmina A. Elliott, MD2Leah M. Backhus, MD3Mark F. Berry, MD4Joseph B. Shrager, MD5Daniel S. Oh, MD6Department of Cardiothoracic Surgery, Stanford University Medical Center, Stanford, Calif; Address for reprints: Lye-Yeng Wong, MD, Falk Cardiovascular Research Institute, 300 Pasteur Dr, Stanford, CA 94305.Department of Medical Affairs, Intuitive Surgical, Sunnyvale, CalifDepartment of Cardiothoracic Surgery, Stanford University Medical Center, Stanford, Calif; VA Palo Alto Health Care System, Palo Alto, CalifDepartment of Cardiothoracic Surgery, Stanford University Medical Center, Stanford, Calif; VA Palo Alto Health Care System, Palo Alto, CalifDepartment of Cardiothoracic Surgery, Stanford University Medical Center, Stanford, Calif; VA Palo Alto Health Care System, Palo Alto, CalifDepartment of Cardiothoracic Surgery, Stanford University Medical Center, Stanford, Calif; VA Palo Alto Health Care System, Palo Alto, CalifDepartment of Medical Affairs, Intuitive Surgical, Sunnyvale, Calif; Department of Cardiothoracic Surgery, VA Palo Alto Health Care System, Palo Alto, CalifObjective: Randomized control trials are considered the highest level of evidence, yet the scalability and practicality of implementing randomized control trials in the thoracic surgical oncology space are not well described. The aim of this study is to understand what types of randomized control trials have been conducted in thoracic surgical oncology and ascertain their success rate in completing them as originally planned. Methods: The ClinicalTrials.gov database was queried in April 2023 to identify registered randomized control trials performed in patients with lung cancer who underwent surgery (by any technique) as part of their treatment. Results: There were 68 eligible randomized control trials; 33 (48.5%) were intended to examine different perioperative patient management strategies (eg, analgesia, ventilation, drainage) or to examine different intraoperative technical aspects (eg, stapling, number of ports, port placement, ligation). The number of randomized control trials was relatively stable over time until a large increase in randomized control trials starting in 2016. Forty-four of the randomized control trials (64.7%) were open-label studies, 43 (63.2%) were conducted in a single facility, 66 (97.1%) had 2 arms, and the mean number of patients enrolled per randomized control trial was 236 (SD, 187). Of 21 completed randomized control trials (31%), the average time to complete accrual was 1605 days (4.4 years) and average time to complete primary/secondary outcomes and adverse events collection was 2125 days (5.82 years). Conclusions: Given the immense investment of resources that randomized control trials require, these findings suggest the need to scrutinize future randomized control trial proposals to assess the likelihood of successful completion. Future study is needed to understand the various contributing factors to randomized control trial success or failure.http://www.sciencedirect.com/science/article/pii/S2666273624000093lung cancerrandomized controlled trialsthoracic surgical oncology |
| spellingShingle | Lye-Yeng Wong, MD Yanli Li, PhD Irmina A. Elliott, MD Leah M. Backhus, MD Mark F. Berry, MD Joseph B. Shrager, MD Daniel S. Oh, MD Randomized controlled trials in lung cancer surgery: How are we doing?Central MessagePerspective JTCVS Open lung cancer randomized controlled trials thoracic surgical oncology |
| title | Randomized controlled trials in lung cancer surgery: How are we doing?Central MessagePerspective |
| title_full | Randomized controlled trials in lung cancer surgery: How are we doing?Central MessagePerspective |
| title_fullStr | Randomized controlled trials in lung cancer surgery: How are we doing?Central MessagePerspective |
| title_full_unstemmed | Randomized controlled trials in lung cancer surgery: How are we doing?Central MessagePerspective |
| title_short | Randomized controlled trials in lung cancer surgery: How are we doing?Central MessagePerspective |
| title_sort | randomized controlled trials in lung cancer surgery how are we doing central messageperspective |
| topic | lung cancer randomized controlled trials thoracic surgical oncology |
| url | http://www.sciencedirect.com/science/article/pii/S2666273624000093 |
| work_keys_str_mv | AT lyeyengwongmd randomizedcontrolledtrialsinlungcancersurgeryhowarewedoingcentralmessageperspective AT yanliliphd randomizedcontrolledtrialsinlungcancersurgeryhowarewedoingcentralmessageperspective AT irminaaelliottmd randomizedcontrolledtrialsinlungcancersurgeryhowarewedoingcentralmessageperspective AT leahmbackhusmd randomizedcontrolledtrialsinlungcancersurgeryhowarewedoingcentralmessageperspective AT markfberrymd randomizedcontrolledtrialsinlungcancersurgeryhowarewedoingcentralmessageperspective AT josephbshragermd randomizedcontrolledtrialsinlungcancersurgeryhowarewedoingcentralmessageperspective AT danielsohmd randomizedcontrolledtrialsinlungcancersurgeryhowarewedoingcentralmessageperspective |