EFPIA CDEG position paper on the use of Form FDA 1572 for clinical trials performed outside the USA

In 2018/2019 the EFPIA Clinical Development Expert Group (CDEG) conducted a survey amongst its member organizations to evaluate the potential impact of the non-acceptance of Form FDA 1572 ex-US by EU Member States. The outcome of this survey showed that standard practices regarding the use of Form FDA 1572 in the EU (or other countries outside US) is not consistent across companies and there seems to be a need to provide clarity and recommendations when the FDA form is rejected by EU national Health Authorities, which could cause undue delay in starting a clinical trial.

Therefore, this position paper provides recommendations as to when a Form FDA 1572 should be used in a clinical trial and when it should not. Three options have been identified, for which the pros & cons are detailed in this position paper.