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Updated: Jul 3, 2025
Pre-clinical Evaluation of Tyrosine Kinase Inhibitors for Treatment of Acute Leukemia
Published on: September 18, 2013
The methodological and reporting quality of randomized controlled trials of tyrosine kinase inhibitors for advanced
Rogério Aparecido Dedivitis1,2, Mario Augusto Ferrari de Castro3, Alice Matos Dal Boni4
1Department of Surgery, Universidade de São Paulo, São Paulo, Brazil.
Introduction:
Clinical trials on tyrosine kinase inhibitors (TKI) treatment have shown an improvement in overall and progression-free survival in patients with advanced differentiated thyroid cancer. However, it is necessary to evaluate these studies to assess methodological biases and inconsistencies that may impact the effects.
Objective:
To map and assess the methodological quality of randomized clinical trials (RCTs) regarding randomization, allocation concealment, blinding, and selective reporting bias.
Methods:
RCTs assessing the efficacy and safety of TKI for the treatment of advanced differentiated thyroid cancer were included. The search was performed in the MEDLINE database. The included RCTs were assessed for the adequacy of the methodological steps, as recommended by the Cochrane Risk of Bias tool.
Results:
Nine studies were analyzed, of which 77.7% were classified as low risk of bias regarding selective reporting and 33.3% as high risk of reporting bias. The mean time between protocol registration and study publication was approximately 5.11 years. Moreover, 66.7% were classified as low risk of bias for randomization and allocation concealment, and 33.3% did not specify the randomization process and allocation concealment in a way that would allow the identification of occurrences of bias. Concerning blinding of participants and outcome assessors, 77.8% of the RCTs reported adequate blinding and were classified as having a low risk of bias, 11.1% had a high risk of bias, and 11.1% had insufficient information and were classified as having unclear risk of bias. Regarding the blinding of the outcome assessors, 33.3% did the blinding correctly, 11.1% did not blind, and 55.6% did not provide enough information.
Conclusion:
Overall, the assessed RCTs were predominantly at low risk of bias. The critical evaluation of these studies is essential to have confidence in the treatment estimated effect that will support clinical decision-making and provide information to preclude future clinical study flaws.
Insights
This study evaluated randomized clinical trials on tyrosine kinase inhibitors (TKI) for advanced differentiated thyroid cancer. Most trials showed low risk of bias, but some had reporting or blinding issues, impacting treatment effect confidence.
Area of Science:
- Oncology
- Clinical Pharmacology
- Evidence-Based Medicine
Background:
- Tyrosine kinase inhibitors (TKI) offer improved survival for advanced differentiated thyroid cancer.
- Methodological quality of clinical trials on TKI treatment requires critical assessment.
- Potential biases may affect the reported efficacy of TKI in thyroid cancer management.
Purpose of the Study:
- To systematically assess the methodological quality of randomized clinical trials (RCTs) for TKI treatment in advanced differentiated thyroid cancer.
- To evaluate RCTs for biases in randomization, allocation concealment, blinding, and selective reporting.
- To identify potential flaws in clinical studies to inform future research and clinical decisions.
Main Methods:
- A systematic search of MEDLINE identified RCTs evaluating TKI for advanced differentiated thyroid cancer.
- The Cochrane Risk of Bias tool was employed to assess methodological quality.
- Key bias domains included randomization, allocation concealment, participant/outcome assessor blinding, and selective reporting.
Main Results:
- Nine RCTs were analyzed, with most demonstrating low risk of bias in selective reporting (77.7%) and randomization/allocation concealment (66.7%).
- However, 33.3% exhibited high risk of reporting bias, and a similar proportion lacked clear reporting on randomization and allocation concealment.
- Blinding of participants and outcome assessors was adequate in 77.8% of studies, but significant portions had high or unclear risk of bias, particularly for outcome assessor blinding (55.6% unclear).
Conclusions:
- The analyzed RCTs for TKI in advanced differentiated thyroid cancer were generally of low methodological risk.
- Critical evaluation revealed inconsistencies, particularly in reporting and blinding, which necessitate careful consideration of treatment effect estimates.
- Addressing these methodological issues is crucial for enhancing confidence in clinical decision-making and improving future trial design.
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