2021-08-13-埃森哲-Reimagining_the_clinical_trial_experience_19页_28mb

Clinical Trial Patient Experience Transformation Summary

Overview

This report highlights the challenges in clinical trials and proposes strategies to enhance patient-centricity. Key issues include high patient dropout rates, recruitment difficulties, and operational inefficiencies, exacerbated by the COVID-19 pandemic.

Key Challenges

• High Attrition and Costs: Approximately 30% dropout rate and an average cost of $2.6 billion per drug trial. 85% of clinical trials fail due to insufficient patient retention.
• Recruitment and Data Issues: 99% of patient health-related activities occur outside hospitals/clinics, leading to under-enrollment (30% under-enrollment rate) and delayed decision-making (62% lack real-time data access).
• COVID-19 Impact: Affects nearly 8.5 million patients across 15,000 trials, potentially disrupting 5,000 trials and 1 million patients in the next six months, with potential losses exceeding $20 billion.
• Stakeholder Barriers: Despite 90% of eligible patients expressing interest in trials, only 3% actually participate. Investigators face enrolling challenges (+20% fail to enroll a single patient), and 19% of studies close early due to accrual issues.

Proposed Solutions

• Patient-Centric Approach: Focus on integrating patient needs into trial design, improving adherence (reducing dropouts) and engagement. Advocate for real-time data capture and analytics to enhance monitoring.
• Transformation Framework: Implement modular strategies such as:
  • Booster: Urgent actions like ethnographic research to boost recruitment and adherence for specific studies.
  • Focus: Targeted initiatives, including patient journey mapping and media optimization.
  • Holistic: Comprehensive strategies targeting the entire portfolio for ecosystem integration.
• Outcomes: Aim for improved metrics, including increased patient participation, faster trial success rates, reduced costs, and better cross-stakeholder collaboration.
• Stakeholder Engagement: Address gaps between intentions and actions by aligning patient, investigator, and sponsor interests, drawing from perspectives that value participation, data quality, and efficiency gains.

Recommendations

• Prioritize early patient involvement and data integration to mitigate risks and optimize clinical trial execution.
• Utilize scalable solutions to handle variances in trial demands, leveraging insights from real-world data and stakeholder feedback.
• Quantify benefits through metrics like reduced dropout rates, improved adherence, and cost savings to demonstrate long-term value.