Amplifying the Patient's Voice in Oncology Early-Phase Clinical Trials: Solutions to Burdens and Barriers

Area of Science:

• Oncology
• Clinical Trial Design
• Patient Access to Care

Background:

• Dose-finding oncology trials (DFOTs) offer early access to new cancer therapies and provide essential safety and dosing data.
• Patient enrollment in clinical trials is hindered by access barriers, with DFOTs facing additional, often overlooked, challenges.

Purpose of the Study:

• To identify and analyze direct and indirect barriers to patient enrollment in DFOTs.
• To propose strategies for minimizing these barriers and improving the patient experience in DFOTs.

Main Methods:

• Review of direct barriers: financial costs, travel, time commitment, and correlative study designs.
• Analysis of indirect barriers: eligibility criteria, washout periods, and medication restrictions.
• Emphasis on patient and advocate involvement and patient-reported outcomes (PROs).

Main Results:

• Direct barriers include significant financial, travel, and time burdens for patients.
• Indirect barriers involve strict trial designs that can be overly exclusionary.
• Patient and advocate input and PROs are vital for effective barrier mitigation.

Conclusions:

• Minimizing barriers in DFOTs requires careful consideration of financial, logistical, and design elements.
• Incorporating patient perspectives throughout the trial process is essential for equitable access to novel oncology treatments.
• Strategic planning can enhance patient experience and broaden access to potentially life-saving therapies.