Patient-reported outcomes in adoptive cell-therapy trials: mind the gap

Area of Science:

• Oncology
• Immunotherapy
• Clinical Trial Methodology

Background:

• Adoptive cell therapies (ACT) are advanced cancer treatments offering potential cures.
• Patient-reported outcomes (PROs) are vital for understanding treatment impact and safety.
• Current inclusion of PROs in ACT trials is limited due to therapy complexity.

Purpose of the Study:

• To discuss the benefits of incorporating PROs into ACT clinical trials.
• To identify challenges associated with administering and collecting patient-reported outcome measures (PROMs) in ACT.
• To propose actionable recommendations for increasing PROM adoption in ACT research.

Main Methods:

• Commentary based on existing literature and expert opinion.
• Discussion of the utility of PROMs in capturing patient perspectives during ACT.
• Analysis of barriers to PROM implementation in complex cell therapy trials.

Main Results:

• ACT offers significant promise for cancer treatment, with potential for long-term remission.
• PROMs are crucial for gathering real-world data on ACT safety and patient experience.
• Challenges in PROM administration and collection hinder their widespread use in ACT.

Conclusions:

• Integrating PROMs into ACT trials is essential for a comprehensive understanding of treatment efficacy and patient well-being.
• Addressing PROM implementation challenges can improve data quality and support clinical decision-making.
• Recommendations are provided to facilitate the adoption of PROMs in future ACT studies.