2024-08-04-亚开行-加强孟加拉国的临床试验生态系统_景观和政策建议（英）_16页_788kb

Strengthening the Clinical Trials Ecosystem in Bangladesh

Bangladesh is focusing on building domestic pharmaceutical and vaccine manufacturing capabilities to enhance its health security and economic prospects, necessitating a stronger clinical trials ecosystem. While Bangladesh demonstrates potential as a clinical trial location, its activity remains relatively low per capita due to several factors:

1. Regulatory and Process Challenges: Prolonged approval timelines, lack of parallel ethics and regulatory reviews, sequential reviews, and centralized ethics committees contribute to delays and burdens. For instance, average approval times are long (up to 5 months).
2. Limited Data Transparency: While there's an online registry, low uptake persists. Data sharing delays and lack of standardized formats hinder transparency and research efficiency. Results publication adherence is not universal.
3. Clinial Trial Infrastructure Deficiencies: There are a limited number of clinical trial sites, mostly concentrated in Dhaka, and insufficient laboratory infrastructure. Public hospitals often lack the necessary diagnostic capabilities.
4. Insufficient Human Resources and Capacity: There's a need for enhanced training and adoption of Good Clinical Practice (GCP) standards for researchers, site staff, and regulatory personnel. Few well-trained investigators and local CRO leadership exist.
5. Limited Incentives & International Integration: Lack of direct government funding, tax incentives for clinical trials or CROs, and no formal membership in major international clinical trial networks limits foreign and domestic investment. Few global CROs have a significant presence in Bangladesh.

Key Challenges and Global Comparisons

• Activity Levels: Despite Asia-Pacific's growing dominance in clinical trials (accounting for more than 50% globally), Bangladesh's contribution remains relatively low.
• Trial Types & Populations: Late-stage trials are historically dominant, but early-stage (Phase I) trials are increasing. Bangladesh offers a large treatment-naïve population, but lacks widespread CRO infrastructure and representation in most global trial networks.
• Funding: Research funding is scarce, leading to reliance on short-term, often foreign funding rather than sustainable domestic investment.

Comparisons to Global Best Practices (#Table Placeholder - comparative data presented in original report)

Recommended Policy Actions and Timeline

High-priority recommendations include streamlining regulatory processes (e.g., enabling parallel ethics/regulatory reviews), enhancing data transparency (implementing efficient e-registries and results reporting), improving clinical trial infrastructure (developing more sites, labs, principal investigator pools), strengthening human resources (training programs), offering targeted incentives (potential tax credits/deductions), and fostering international collaborations.

Implementation Timeline

The report provides a proposed implementation timeline prioritizing actions categorized as Short (requiring immediate focus), Medium, or Long-term efforts, highlighting the expected ease of implementation and anticipated impact.

Key Conclusions

A robust clinical trials ecosystem is vital for Bangladesh to achieve self-sufficiency in vaccines and therapeutics, improve public health outcomes, enhance global research collaboration potential, and stimulate economic growth. Systemic reforms focusing on regulatory efficiency, data transparency, infrastructure development, and human resource capacity are essential for strengthening this ecosystem.