The clinical trial transparency in oncology significantly increased over the recent years
Seung Yeon Song1, EunYoung Kim2
1Department of Health Science and Clinical Pharmacy, Chung-Ang University College of Pharmacy, Seoul, Republic of Korea.
Objective:
Persistent efforts have been made to promote clinical trial transparency, which included encouraging trial registration and prospective registration, as well as protocol disclosure. This study aims to analyze the extent of registration, prospective registration and protocol disclosure in oncology clinical trials and their changing trends.
Study Design And Setting:
All phase II and phase III oncology clinical trials published in 5 major journals, the Annals of Oncology, the Journal of Clinical Oncology, JAMA Oncology, The Lancet Oncology, and The New England Journal of Medicine, between January 2013 and December 2017, were included. Data on trial characteristics as well as registration status and availability of protocol and its location were collected.
Results:
In total, 625 articles were included, 92% were registered, of which 76% were prospectively registered. Overall, 27% provided protocols. Increasing trends were observed in registration, prospective registration, and protocol disclosure (all P < 0.001). Studies with enrollment number larger than median number were more likely to be registered (adjusted odds ratio (aOR), 3.14 [95% confidence interval (CI), 1.21-8.15]) and to provide protocols (aOR, 3.84 [95% CI, 2.24-6.57]) than those with smaller enrollment number. Studies with nonindustry funding was less likely to be prospectively registered (aOR, 0.37 [95% CI, 0.25-0.55]) but more likely to provide protocols (aOR, 1.69 [95% CI, 1.13-2.52]) than those with industry funding only.
Conclusion:
Although the rates of registration, prospective registration, and protocol disclosure of oncology trials have significantly increased over the years, there is still room for improvement.
Insights
Oncology clinical trial transparency is improving, with significant increases in trial registration, prospective registration, and protocol disclosure over time. However, further enhancements in clinical trial reporting are still needed.
Area of Science:
- Clinical Oncology
- Medical Research Transparency
- Scientific Publication Ethics
Background:
- Clinical trial transparency is crucial for research integrity and reproducibility.
- Efforts to enhance transparency include trial registration and protocol disclosure.
- Assessing trends in these practices is vital for evaluating progress.
Purpose of the Study:
- To analyze the extent and trends of registration, prospective registration, and protocol disclosure in oncology clinical trials.
- To identify factors influencing these transparency measures.
Main Methods:
- Systematic review of phase II and III oncology trials published between 2013-2017 in five major medical journals.
- Data collection on trial registration status, prospective registration, and protocol availability.
- Statistical analysis to determine trends and influencing factors.
Main Results:
- 92% of trials were registered, with 76% prospectively registered; 27% provided protocols.
- Significant increasing trends observed in registration, prospective registration, and protocol disclosure (P < 0.001).
- Larger trials and non-industry funded trials showed specific patterns in registration and protocol disclosure.
Conclusions:
- Oncology trial registration, prospective registration, and protocol disclosure have significantly increased.
- Despite progress, opportunities remain to further improve clinical trial transparency in oncology research.
More Related Videos
08:29Ex Vivo Treatment Response of Primary Tumors and/or Associated Metastases for Preclinical and Clinical Development of Therapeutics
Published on: October 2, 2014
07:50Global and Current Research Trends of Single-Cell Sequencing in Cancer: A Bibliometric and Visualization Study
Published on: April 18, 2025
Related Concept Videos
Clinical Trials: Overview
Clinical Trials
There are four phases in a clinical trial. A phase one...
Treatment Resistant Cancers
Targeted Cancer Therapies
There are several types of targeted therapies against...
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
Cancer Therapies
However, cancer treatments can pose several challenges, as therapies used to kill cancer cells are generally also toxic to normal cells. Moreover, cancer cells mutate rapidly and can develop resistance to chemical agents or radiation therapy. Besides, all types of cancer cells may not respond to the same therapy. Some cancer cells respond to one...
