Evolving landscape and academic attitudes toward the controversies of global immuno-oncology trials.

Abstract

This cross-sectional and longitudinal descriptive analysis aimed to track the evolving landscape of global immuno-oncology (IO) trials and provide insight into the resolution of IO-related controversies. Clinical trials (n = 4510) registered on ClinicalTrials.gov in 2007 to 2019 studying immune checkpoint inhibitors (ICIs), adoptive cell transfer (ACT), cancer vaccines and immune modulators were included. Most of IO trials are Phase 2 and focus on ICIs and multiple IO therapies. The United States leads global IO research, with stable growth and the best methodological quality. Mainland China ranks first in the number of ACT trials but has the lowest article publication rate (6.2%). A multiple-arm comparative design is often adopted in multiple IO therapies trials (44.0%). Trials studying ICIs and multiple IO therapies are likely to use early registration (80.0% and 86.6%) and stringent corticosteroid-/infection-related criteria. Hospitals have provided the most extensive and strongest support for all IO categories. Big pharma prefers to fund Phase 3-4 ICI trials (6.98%), while small pharma has a wider sponsorship favoring Phase 1-2 trials. The "partial-use-of-corticosteroids" strategy is generally well accepted in ICI trials with a definitive trend (32.5%; P < .001) but is associated with the poor dissemination of results (P ≤ .020), while the complete disclosure and standardization of dose/timing limits are still lacking. Disparities in design features and dissemination of results are widespread in IO trials and are modulated by IO category, cancer type and sponsor. We propose policy reforms to redefine the timely publication of IO trials and standardize the resolution of corticosteroid-/infection-related issues.

• Authors: Cheng Xu, Shu Zhang, Yuan Zhang, Si-Qi Tang, Xue-Liang Fang, Guang-Li Zhu, Liang Peng, Jin-Qi Liu, Yan-Ping Mao, Ling-Long Tang, Qing Liu, Ai-Hua Lin, Ying Sun, Jun Ma
• Journal: International journal of cancer (Int J Cancer) Vol. 149 Issue 1 Pg. 108-118 (07 01 2021) ISSN: 1097-0215 [Electronic] United States
• PMID: 33544890 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: © 2021 The Authors. International Journal of Cancer published by John Wiley & Sons Ltd on behalf of Union for International Cancer Control.

Chemical References

• Immune Checkpoint Inhibitors

Topics

• Academies and Institutes
• Attitude of Health Personnel
• Clinical Trials as Topic (standards)
• Cross-Sectional Studies
• Health Knowledge, Attitudes, Practice
• Humans
• Immune Checkpoint Inhibitors (therapeutic use)
• Immunotherapy (trends)
• Longitudinal Studies
• Neoplasms (drug therapy, immunology)
• Practice Patterns, Physicians' (standards)
• Prognosis