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. 2022 Jun 7;112(4):817–823. doi: 10.1002/cpt.2641

Table 4.

Comparison of EACTs with CU programs conducted in the United States and Europe

Japan United States Europe
Type Cohort

Cohort

Single patient

Cohort

Single patient (United Kingdom, France)

System Performed as a clinical trial

Separate from clinical trials (Administration within 30 days of application feasible)

Emergency use system available

Separate from clinical trials (Prior application to the regulatory authority for each country)
Target drugs Investigational products for which there is high social demand and pivotal clinical trials have been conducted or are ongoing Investigational products in the United States Investigational products for which marketing authorization will be requested from the EMEA or those under investigation
Target patients Serious or life‐threatening diseases for which there are no alternative treatments

Serious or life‐threatening diseases for which there are no alternative treatments

The expected benefit from the study drug justifies the risk

Serious or life‐threatening diseases for which there are no alternative treatments
Period From the completion of enrollment in pivotal clinical trials until approval

Cohort: After safety confirmation and preliminary efficacy confirmation until approval

Single patient: From before/after clinical trials until approval

Cohort (Germany): Until 1 year after marketing approval

Does not adversely affect the development of the investigational product (does not adversely affect the progress of clinical trials).

There are reasonable grounds for not being able to participate in clinical trials.

CU, compassionate use; EACTs, Expanded Access Clinical Trials; EMEA, European Medicines Evaluation Agency.