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Randomized controlled trials in lung cancer surgery: How are we doing?
Lye-Yeng Wong1, Yanli Li2, Irmina A Elliott1,3
1Department of Cardiothoracic Surgery, Stanford University Medical Center, Stanford, Calif.
JTCVS Open
|May 1, 2024
Summary
Conducting randomized control trials in thoracic surgical oncology is challenging. Most trials focus on perioperative strategies, and a significant number face long completion times, suggesting a need for careful planning.
Area of Science:
- Thoracic Surgical Oncology
- Clinical Trial Design
- Evidence-Based Medicine
Background:
- Randomized control trials (RCTs) are the gold standard for medical evidence.
- Implementing RCTs in thoracic surgical oncology presents unique scalability and practicality challenges.
- The success rate of completing these trials as planned is not well understood.
Purpose of the Study:
- To identify the types of RCTs conducted in thoracic surgical oncology.
- To determine the completion rates of these RCTs.
- To understand the characteristics and timelines of completed thoracic surgical oncology RCTs.
Main Methods:
- A systematic search of the ClinicalTrials.gov database was performed in April 2023.
- The search focused on RCTs involving lung cancer patients undergoing surgical treatment.
- Data on trial design, completion status, and timelines were extracted and analyzed.
Main Results:
- 68 eligible RCTs were identified, with 48.5% focusing on perioperative or intraoperative strategies.
- A notable increase in RCTs occurred after 2016.
- Only 31% of RCTs were completed, with an average accrual time of 4.4 years and outcome collection taking 5.82 years.
Conclusions:
- The findings highlight significant challenges in completing RCTs in thoracic surgical oncology.
- Given the resource-intensive nature of RCTs, future proposals require rigorous scrutiny for feasibility.
- Further research is needed to identify factors contributing to RCT success or failure in this field.
