Sponsors planning trials in the EU that will rely on data from patient registries should consult early in the process with the European Medicines Agency (EMA) to ensure that the data gathered from the registry is valid and relevant, according to new guidelines from the EMA.

If a registry-based trial will use a study design other than the traditional randomized controlled clinical trial, sponsors also should seek advice from national regulatory authorities, health technology assessment bodies and health insurance payers on the acceptability of that design, the EMA says.

The study protocol should include an explanation of how data validity will be ensured. Informed consent should be obtained from registry participants to use their data in the specific trial.

The guidelines also walk sponsors through the process of conducting a registry-based study, describing study planning, protocol and study population considerations, how to handle informed consent and how to protect participants’ private data.

Read the full guidelines here: https://bit.ly/3Gy2vTA.