Terms of Reference: Harmonization of Regulatory Standards for Clinical Research and Trials

Nigeria faces a significant burden from both communicable and non-communicable diseases, which strains the healthcare system and hinders economic development. Despite ongoing efforts to address these challenges, the country remains heavily reliant on imports for essential health commodities. This dependency leads to high costs, supply chain vulnerabilities, and inconsistent availability of critical healthcare products. Strengthening local capacity and optimizing supply chain management is essential to improving the accessibility, affordability, and sustainability of healthcare products.

Market shaping strategies have proven successful in other health sectors by leveraging economies of scale, improving quality control, and enhancing distribution efficiency. Adopting this model for manufacturing and distributing essential health commodities could reduce costs, improve product consistency, and ensure more reliable supply chains. However, transitioning from an import-dependent system to one with a robust local production capacity and an efficient pooled procurement system is a complex process. It requires a comprehensive, multi-faceted approach that addresses manufacturing capabilities, quality assurance mechanisms, supply chain optimization, workforce capacity building, and supportive policy frameworks.

The Presidential Initiative for Unlocking Healthcare Value Chain (PVAC) and the National Malaria Elimination Programme (NMEP), with the support of the World Bank IMPACT, embarked on a project called "Enhancing Local Manufacturing and Supply Chain Management for Health Commodities and Supplies in Nigeria." This project aims to address these challenges through a phased approach that balances short-term and long-term objectives. The strategies for addressing these challenges will include developing and laying the groundwork for local manufacturing of malaria commodities (including ACTs, RDTs, APIs, and LLINs), enhancing production capacity, ensuring compliance with international quality standards, and fostering workforce development. At the same time, the project will focus on optimizing the pooled procurement of imported malaria commodities to improve cost-effectiveness and distribution efficiency. Over the medium to long term, these interventions will strengthen the entire health commodities value chain, create opportunities for economic growth, and support Nigeria's self-sufficiency in critical healthcare products. This comprehensive approach seeks to improve Nigeria's healthcare supply systems' efficiency and resilience while unlocking new economic opportunities within the country's health sector.

This assignment aims to develop a comprehensive framework for the regulatory harmonization of clinical research and trials standards across relevant stakeholders, ensuring alignment with international best practices. This framework will support a conducive environment for the conduct of clinical research and trials, improving the efficiency, ethical standards, and scientific integrity of such activities in Nigeria.

The scope of work for this consultancy includes the following:

• Policy and Regulatory Review:

  • Assess current national and regional regulations related to clinical trials, identifying gaps and inconsistencies with international standards (e.g., WHO, AVAREF, ICH-GCP, FDA, EMA, NHREC, NAFDAC).
  • Compare the existing regulatory environment with best practices from leading global regulatory bodies.
  • Review all available clinical trials registries (e.g., clinicaltrial.gov, https://nctr.nhrec.ne, https://pactr.samrc.ac.za, https://nafdac.gov.ng/clinical-trial-database) in line with the regional regulatory requirements.

• Conduct stakeholder consultations through key informant interviews

  • Conduct key informant interviews with regulatory agencies and policymakers for clinical research and trials
  • Gather feedback on regulatory challenges, constraints, and opportunities for improvement.
  • Facilitate multi-stakeholder dialogues for consensus-building.

• Framework Development:

  • Develop a harmonized regulatory framework for clinical trials, focusing on simplifying and streamlining approval processes while ensuring ethical standards and patient safety.
  • Recommend a unified clinical trial procedure, guidelines, and standards.
  • Include a list of clinical research registries.

• Draft an implementation roadmap and policy recommendations

  • Create an action plan with timelines, responsible parties, and key milestones for adopting and implementing the harmonized regulatory framework.

• Organize a one-day validation workshop

  • Present findings, standards, and the implementation roadmap to stakeholders.
  • Solicit feedback, validate assumptions, and refine recommendations.
  • Strengthen buy-in and collective commitment to reform.

Clinical research and trials are pivotal in advancing medical knowledge, improving health outcomes, and informing public health policies. However, inconsistent and fragmented regulatory frameworks often hinder the efficiency and quality of clinical trials, leading to delays, unnecessary duplications, and challenges in maintaining high ethical standards. This challenge has significant implications for the scientific community and public health, particularly in regions where clinical trials are essential for addressing local health challenges. To address this, PVAC seeks a qualified consultant to harmonize regulatory standards for clinical research and trials, streamlining approval processes, enhancing ethical and scientific integrity, and fostering a more transparent and efficient regulatory environment.

1. Document Review:

   • Analyze existing regulatory policies, laws, and frameworks for clinical research and trials.
   • Identify gaps, strengths, and opportunities for alignment with current needs and best practices.
   • Review past assessments, compliance records, and historical documents to understand regulatory evolution.

2. Key Informant Interviews (KIIs):

   • Conduct in-depth interviews with regulatory agencies and policymakers that govern the activities of clinical research and trials in Nigeria
   • Explore challenges in implementation, enforcement, and potential areas for improvement.
   • Understand institutional capacity gaps and barriers to effective regulation.

3. Comparative Analysis:

   • Benchmark Nigeria's regulatory practices against regional and international standards.
   • Identify global best practices and assess how similar countries have addressed regulatory challenges.
   • Use case studies and literature to inform recommendations for improvement.

4. Consensus Building:

   • Convene technical workshops and validation meetings with stakeholders to co-develop the harmonized framework.
   • Use evidence from KIIs and comparative analysis to refine proposals.
   • Ensure the framework reflects stakeholder input and promotes sustainable, effective regulation.

The expected outcomes include:

• Inception report outlining methodology, work plan, and timelines.
• Draft harmonized regulatory framework for clinical research and trials.
• Implementation roadmap (with indicators, responsibilities, timeline).
• Presentation of findings at a validation workshop.
• Finalized harmonized regulatory framework.

The selection process will follow a Limited Consultant Qualification-Based Method (LCQBM). Under this approach, interested consultants/consulting firms will submit proposals in response to the Terms of Reference (TOR) issued by PVAC. As part of the evaluation, consultants/consulting firms must demonstrate their relevant experience and qualifications in managing similar projects. Only the most qualified consultants or firms with proven expertise in project management, monitoring & evaluation, and health supply chain optimization will be shortlisted and considered for final selection.

The required expertise for this scope of work includes:

• Senior clinical research professional with extensive experience in regulatory affairs and clinical trials.
• Expertise in clinical trial regulations and harmonization processes, with experience in local and international regulatory environments.
• In-depth understanding of the public health landscape and how clinical trials align with health system priorities.
• Experienced in managing multi-stakeholder processes, including government agencies, the private sector, and NGOs.
• Knowledge of ethical considerations in clinical trials and research, ensuring adherence to international and local ethical guidelines.
• Skilled in coordinating work plans, timelines, and deliverables for clinical research projects.

2 months -- May to June, 2025

Interested organizations are expected to submit the following documents:

1. Technical Proposal: The technical proposal should include:

• A clear methodology that demonstrates expertise in managing this project.
• A track record and experience in implementing similar projects

2. A valid CAC certificate (or equivalent)

3. Financial Proposal -- including clear budget narratives.

All required documents should be sent to [email protected] on or before May 19^th, 2025. Proposals sent after this date will not be considered.