Expert Guidance for Individual & Cluster Randomized Trials
This 90-minute Zoom-based consultation is designed for researchers, trial sponsors, and public health professionals developing individual or cluster randomized clinical trials, particularly in the areas of public health interventions and new drug applications (NDAs).
We specialize in early-phase planning, methodological clarity, and documentation aligned with international standards.
What we cover:
Trial design consultation (individual and cluster randomization)
Guidance on SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials)
For cluster trials, we follow CONSORT extension for cluster randomized trials
Outcome selection and alignment with study objectives
Randomization, masking, and adherence planning
Site selection and recruitment strategy
Data collection scheduling and flow
Ethical considerations for vulnerable or community-based populations
Integration of qualitative components when appropriate
Who it's for:
Researchers preparing for funding or IRB
Teams planning NDAs or public health interventions
NGOs and academic institutions in low-resource or global health settings
Duration: 1 hour 30 minutes
Location: Zoom