Patient information in phase 1 trials: A systematic review

Area of Science:

• Oncology
• Clinical Trials
• Patient Decision-Making

Background:

• Phase 1 clinical trials are crucial for new cancer drug development.
• Understanding patient and family decision-making processes is vital for trial recruitment.
• Information provided to patients and families significantly impacts trial participation.

Purpose of the Study:

• To systematically review factors influencing cancer patients' decisions to enter phase 1 trials.
• To examine how patients and their relatives perceive information during the informed consent process for phase 1 trials.

Main Methods:

• Systematic review adhering to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.
• Comprehensive literature search across PubMed, Embase, and PsycInfo databases.
• Inclusion of 37 studies investigating patient decision-making in phase 1 trials.

Main Results:

• Patient decisions are influenced by drug, information, physician factors, and personal decision-making style.
• Patients often struggle to recall the exact purpose of phase 1 trials.
• Many patients expect personal benefit; physician communication can be incomplete.
• Relatives' perceptions of information are largely unstudied; most included studies had high risk of bias.

Conclusions:

• Patient decisions for phase 1 trials involve multifaceted factors beyond trial information.
• Current methods for assessing patient understanding of trial information may be limited.
• The role of relatives as support resources in phase 1 trial decisions remains an unexplored area.