2021 Volume 61 Issue 3 Pages 163-170
Objective. To improve the clinical guidelines for lung cancer. Methods. By focusing on the discussion topics at a symposium held in the annual meeting of the Japan Lung Cancer Society 2020 and the results of two independent external evaluations of the guidelines, the history, advantages and limitations of the guidelines were reviewed with respect to problems to be solved. Results. The guidelines were established in 2003 and have been updated annually since 2011. Their contemporary and scientific validity are highly evaluated by external evaluations, whereas the constitutive framework has found to be lacking in many aspects. Rapid advancement in molecular target therapy and therapy with immune checkpoint inhibitors has forced changes in the methodology of clinical trials and in statistical interpretation, resulting in multiple recommendations for a certain specific disease condition. It is important to address the wide diversity of values used for the evaluation of therapeutic outcomes. Conclusion. Problems include heterogeneity in clinical trials, the methodology of interpretation and individual values. Although various medical staff, biostatisticians and patients were already involved in the process of preparing the guidelines, much wider discussion among various stakeholders should be undertaken to solve these problems and improvements that reflect external evaluation should be implemented.
