Lack of international coordination | • Complex and diversified regulatory landscape • Variations and incompatibilities |
Uncertainty and lack of clarity in regulations | • Difficult to read and understand • Lack specificity and clarity |
Organizational complexity from interactions with medical authorities and regulatory entities | • Information available online not always current or user-friendly • Requirements vary by country and regulatory authority |
Costs and infrastructure requirements | • Lack compatible infrastructure across clinical trial sites • Funding and disproportionate financial burden (academia) |
Cultural and logistical disparities | • Variations in ethical (e.g. REB approval), confidentiality and privacy requirements from country to country |
Unproven therapies | • Small number of approved cellular therapies on the market • High price tag • Gaps in oversight and enforcement of such mechanisms |