Like FDA, EMA prioritizes patient safety and data integrity in clinical trials amid outbreak

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Days after FDA outlined its thinking on adjustments to planned and ongoing clinical trials during the COVID-19 outbreak, EMA has followed suit with guidance that echoes many of the U.S. regulator's recommendations.

Like FDA's guidance, which was issued Wednesday, the EMA document emphasizes maintaining trial participants' safety and well-being amid anticipated changes to studies, while preserving the trials' integrity as much as possible (see "FDA Stresses Trials' Safety, Integrity During Outbreak").

EMA stressed that when sponsors evaluate risk and benefit associated with implementing changes to a trial, in cases where ensuring the validity of a trial's data may conflict with patients' safety, the latter should always prevail.

Both documents say that sponsors may introduce alternative methods of monitoring patients, including via phone and video visits, as well as remote monitoring of trial sites. Any changes to trial protocols are to be evaluated with patients' best interest in mind, EMA wrote.

The two agencies each said that in certain cases, sponsors may implement some emergency changes that are communicated to authorities after the fact. EMA's guidance said such actions are permissible when an event has a "serious effect" on risk-benefit, and "urgent safety measures" are needed to protect subjects against "immediate hazard."

EMA's guidance also includes a section on informed consent, and says alternative procedures may be considered if physical consent documentation cannot leave a COVID-19 patient's isolation room.

EMA urged trial sponsors proceeding with studies should bear in mind that the burden on medical personnel is high, and said some risk-benefit analyses will have to be re-assessed as the COVID-19 situation continues to develop.

Further analysis of the coronavirus crisis can be found at https://www.biocentury.com/coronavirus.

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