Resources
Resources from public consultation for the development of Guidance for best practices for clinical trials
Resources on implementation of proportionate risk-based approach
- Case Study: University of Oxford CTSU
- Case Study: DCRI Streamlines Protocol Using Quality by Design Thinking
- Case Study: Emphasis on Protocol Design Helps Alexion with Timeline Adherence
- Case Study: The Medicines Company Developed Nimble Protocols to Scale for Global Trials
- University of California Irvine’s Multidisciplinary Trial Design Studios Yield Streamlined, Considered Protocols
- 2017_04_25_risk_proportionate_approaches_in_clinical trials.pdf
- OECD Legal Instruments-Recommendation of the Council on the Governance of Clinical Trials
- Enhancing clinical evidence by proactively building quality into clinical trials - PubMed
Other resources
- WHA58.22 Ministerial Summit on Health Research
- WHA75.8 Strengthening clinical trials to provide high-quality evidence on health interventions and to improve research quality and coordination
- International Clinical Trials Registry Platform (ICTRP)
- WHO’s guidelines on Good Participatory Practice for trials of (re-)emerging pathogens (GPP-EP)
- Sharing and reuse of health-related data for research purposes: WHO policy and implementation guidance
- International Standards for Clinical Trial Registries
- TDR, the Special Programme for Research and Training in Tropical Diseases
- Orphanet collaboration (rare diseases)
- Coordinating R&D on antimicrobial resistance
- Control of Neglected Tropical Diseases - The NTD road map: together towards 2030
- WHO target product profiles
- WHO global accelerator for paediatric formulations (GAP-f)