2025-05-06-艾昆纬-优化临床试验启动时间_在合同效率上竞争（英）_15页_3mb

Optimizing Clinical Trial Startup Times: Competing on Contracting Efficiency Summary

This white paper examines the optimization of clinical trial startup times through the harmonization of contract templates and budgeting across key European locations.

Context

• Clinical trial location competition is intensifying globally. Shorter start-up times (contracting cycles) are crucial.
• Germany, once Europe's leading location, faces competition; its position has weakened over the past decade.
• Official stakeholders (associations, government) are collaborating to standardize contracts to improve Germany's standing.

Key Findings

1. Global R&D Spending: Pharmaceutical R&D spending remains substantial (e.g., ~USD 160 billion in 2023), driving innovation globally.
2. Competition: Countries compete fiercely for clinical trials, seeking to boost their economic competitiveness and gain early access to treatments.
3. Contract Templates Impact:
   • Countries adopting national contract templates (like France 2014) saw raw reductions in median contracting cycles (e.g., >40%).
   • Sites using national templates negotiated contracts faster.
   • Harmonized templates (e.g., CRO-specific) help reduce negotiation times and align budgets (though pure budget harmonization had mixed results).
4. Examples:
   • France's mandatory template approach significantly cut cycles post-2014.
   • Spain's regional site templates also reduced cycles further but required site-by-site adoption.
   • Germany's approach uses optional templates first, aiming for mandatory clauses in 2025/2026.
   • Ireland's implementation showed initial but reversed cycle time benefits post-introduction.
   • The UK was an early adopter but the UK data sample size limited conclusive analysis.
5. Germany:
   • Mandatory CTA clauses are expected soon under the National Pharmaceutical Strategy and Medicine Research Act.
   • Industry associations (vfa, BPI, KKS) developed a draft ("Model Contract Clauses") in 2023, which over ~75% of IQVIA's strategic sites in Germany already accept, often with minor adaptations.
   • Sites that don't fully accept plan immediate reconsideration/evaluation.
6. Impact: Standardizing contract clauses offers the potential to significantly shorten startup times by reducing time spent on standard negotiations, freeing up resources at trial sites, and making the location more attractive.

Recommendations

Based on international experience, the introduction and broad adoption of harmonized contract templates contribute positively to speeding up clinical trial start-up times, enhancing competitiveness.