2024-05-26-艾昆纬-学习创业的挑战_严峻的现实_有效的策略（英）_8页_1mb

Study Start-Up Challenges: Hard Realities, Effective Strategies

Core Content

The white paper discusses the challenges faced by pharmaceutical and biotech companies in accelerating clinical trial start-up timelines. It highlights that the average time between protocol approval and the first patient visit has increased by 45% since 2015, primarily due to site capacity issues, increased regulatory demands, and the complexity of site readiness. Despite these challenges, industry leaders from IQVIA and Novartis have implemented strategies to mitigate delays and improve efficiency.

Main Challenges

• Site Capacity Challenges:

  • A significant number of sites are overwhelmed with demand, leading to higher rates of declining new trials.
  • 26% of survey respondents reported increased new trial decline rates due to site capacity issues.

• Contracting and Approval Delays:

  • Contract negotiation times have increased due to inflation and higher site costs.
  • 49% of sites declined studies partly due to insufficient investigator grants.
  • The new EU Clinical Trial Regulation (EU CTR) has introduced additional complexity and time for contract execution.

• Site Readiness Complexity:

  • Sites must manage more requirements to be ready for enrollment, increasing the burden.
  • There has been a 61% increase in the number of standard vendors per trial since 2018.

Key Strategies for Improvement

1. Site Identification and Selection

• Leveraging Local Knowledge and Relationships: IQVIA RDS uses its extensive experience and relationships with specific sites to streamline the selection process.
• Investigator Support: Providing training materials and resources helps investigators make informed decisions and reduces the time spent on communication.
• Technology Integration: Tools like the IQVIA Feasibility module allow for pre-populated data, reducing redundant questions and accelerating site selection.

2. Contracting and Regulatory Approvals

• Single Point of Contact: Reducing internal handoffs and keeping a single point of contact with sites improves communication and reduces workload.
• Technology for Efficiency: The IQVIA Feasibility and Site Activation modules support streamlined documentation and regulatory submissions.
• Flexible Feasibility Process: Adjusting site search based on country, study type, and site load ensures more efficient resource allocation.

3. Site Readiness and Activation

• Front-Loading Tasks: Planning and executing essential tasks early helps reduce delays in site activation.
• Early Access to Training: Cross-trial training systems that offer credits for completed sessions help accelerate the activation process.
• Technology Platforms: Platforms like the IQVIA Investigator Site Portal and Novartis Connect provide integrated solutions for communication, training, and documentation, ensuring a consistent and efficient experience for sites.

Industry Insights

• Kerry Randall (Vice President and Global Head of Site Activation for IQVIA R&D Solutions) emphasized that while site identification efforts are increasing, the overall cycle time has been reduced by 22% through internal process improvements and technology use.
• Raphaëlle Gilg (Strategy and Operations Manager for Novartis Pharmaceuticals) highlighted the importance of technology in streamlining documentation and ensuring compliance without unnecessary paperwork.
• Rodrigo Guimarães (Vice President of Global Site Activation for IQVIA R&D Solutions) noted the impact of organizational structure and leadership in driving site activation efficiency.
• Rosemary Shirey (Associate Director of Client Services for IQVIA Technologies) discussed the role of technology in enabling innovative solutions for site challenges.

Conclusion

The industry is facing significant headwinds in study start-up timelines, but through focused strategies and technology integration, companies like IQVIA and Novartis are making measurable progress. The key lies in combining local expertise, streamlined processes, and technology to reduce delays and improve the efficiency of clinical trial activation.