Skip to main content
. 2021 Mar 1;47(4):470–472. doi: 10.1007/s00134-021-06367-5

Table 1.

Demographics and baseline characteristics (open-label safety analysis set)

What went wrong? Solutions
Small observational studies with highly variable results Creation of national or international registries with harmonized data collection for emerging disease outbreaks that are operational both during and outside pandemic periods
Absence of observational data from outside traditional academic or research centres Creation of national or international registries that collect data from all hospitals within a given jurisdiction
Few observational studies from low- and middle-income countries

Implementation of national electronic medical record systems in low and middle-income countries to allow for easy (or automated) data collection.

National audits or registries for critical illness

Too many small clinical trials with inconclusive results

Avoidance of single centre and single region therapeutic trials

Creation of national or regional ethics review boards

Coordinated data collection between clinical trial networks

Prioritization of large scale multicentre studies as well as collaborations between investigators with overlapping interests

Medical societies to encourage clinical trial participation in place of off-label therapy use

Too many overlapping/competing clinical trials

Collaboration across clinical trial networks and funding agencies to ensure fewer, large-scale studies are funded or that small studies work together to generate larger datasets

Prioritization of adaptive platform trials that enable parallel testing of multiple therapeutic options

Bureaucratic delays in setting up clinical trials

Fast-track approvals for pandemic-related clinical trials

Creation of national or regional ethics review boards

Few therapeutic trials in low- and middle-income countries

Inclusion of low and middle-income countries in international multi-centre clinical trials

Creation of clinical trial networks that include both high- and low-income countries

Simplification of data collection forms

Simplification of trial protocols

Simplification of regulatory requirements for trials using already approved medications