New Benchmarks on Protocol Amendment Experience in Oncology Clinical Trials

Area of Science:

• Clinical Trials
• Drug Development
• Oncology

Background:

• The complexity of oncology drug development is increasing, driven by narrow patient populations and intricate procedures.
• This study investigates differences between oncology and non-oncology clinical trials to identify performance optimization opportunities.

Purpose of the Study:

• To compare the impact and causes of protocol amendments in oncology versus non-oncology clinical trials.
• To identify factors contributing to the complexity and performance of oncology trials.

Main Methods:

• Data from 950 protocols and 2,188 amendments from 16 companies were analyzed.
• A comparative analysis was conducted between 249 oncology and 701 non-oncology protocols.

Main Results:

• Oncology protocols showed a higher prevalence (91.1%) and number (4.0) of amendments compared to non-oncology (72.1%, 3.0).
• Oncology trials with amendments had significantly lower participant completion rates.
• The COVID-19 pandemic exacerbated amendment numbers, lower completion, and higher dropout rates in oncology trials.

Conclusions:

• Preventing avoidable protocol amendments in oncology trials remains a significant challenge.
• Increasingly complex oncology trial designs contribute to unpredictable timelines, recruitment/retention barriers, and more amendments.