What Is Ailing Oncology Clinical Trials? Can We Fix Them?

Area of Science:

• Oncology
• Clinical Trial Design
• Translational Research

Background:

• Phase three clinical trials are crucial for advancing cancer care and shaping clinical practice.
• Currently, a very small percentage of cancer patients participate in clinical trials, and many trials experience delays due to slow patient accrual.
• Existing trial protocols often have restrictive eligibility criteria and logistical hurdles that limit patient access and trial efficiency.

Purpose of the Study:

• To identify and analyze the key barriers hindering patient participation and timely completion of cancer clinical trials.
• To discuss practical solutions for enhancing patient-centricity and accessibility in clinical trial design and conduct.
• To provide insights for investigators, patients, and regulatory bodies to improve the clinical trial ecosystem for cancer therapeutics.

Main Methods:

• This review synthesizes real-world observations and experiences from clinical trialists.
• It critically examines common issues in trial design, eligibility criteria, regulatory processes, and trial conduct.
• Potential solutions are discussed based on practical challenges encountered in cancer clinical trials.

Main Results:

• Restrictive eligibility criteria limit patient access without clear safety benefits.
• Regulatory, organizational, and institutional hurdles cause significant delays in trial activation.
• Non-patient-centric trial conduct, including mandatory in-person visits and inflexible protocols, deters participation.

Conclusions:

• Addressing barriers in clinical trial design and conduct is essential for accelerating the availability of novel cancer drugs.
• Implementing patient-centric approaches and streamlining processes can significantly improve trial accrual and completion rates.
• Collaborative efforts among stakeholders are needed to make cancer clinical trials more accessible and efficient.