Challenges in Implementing Hospice Clinical Trials: Preserving Scientific Integrity While Facing Change

Area of Science:

• Clinical research
• Hospice care
• Trial design

Background:

• Clinical trial designs often diverge from initial plans due to real-world implementation challenges.
• Hospice settings present unique environmental obstacles impacting trial design, recruitment, and staffing.

Purpose of the Study:

• To share lessons and problem-solving strategies for future hospice clinical trials.
• To address challenges encountered during the implementation of a hospice trial.

Main Methods:

• Utilizing a single hospice clinical trial as a case study.
• Analyzing preliminary data from the initial months of the trial.
• Examining protocol deviations from the original funding proposal.

Main Results:

• Hospice setting changes necessitated modifications in trial design, sampling, and recruitment within the first year.
• The adaptive decision-making process led to an improved study design with enhanced generalizability.
• Protocol adjustments positioned the study for translational outcomes post-completion.

Conclusions:

• Early review of clinical trial protocols and statistical plans is recommended.
• Investigators must prepare for external market and environmental changes.
• Continuous monitoring of recruitment and other data is advised for successful trial management.