FDA Answers Questions in Update of COVID-19 Clinical Trial Guidance
Sponsors that choose to conduct remote trial monitoring during the COVID-19 crisis should focus on the most critical site documentation and source data and ensure the security of the data by creating a secure electronic viewing portal or using a sponsor-controlled electronic system or cloud-based repository, says an updated guidance the FDA released last week.
The expanded guidance adds several new question-and-answer segments to the agency’s March 18 guidance on conducting clinical trials during the COVID-19 crisis, including advising sites to use fax, email and phone communication to obtain informed consent from patients unable to travel to the trial site as long as the approach includes a method of ensuring the signer of the consent is actually the person who intends to enroll in the trial.
The FDA also says infusion of an investigational drug may be done by a local healthcare provider who is not involved in the trial as long as that person has the appropriate training and is supervised by a physician with experience in administering the class of the drug involved.
In the case of trials of drugs with FDA approval for other indications, the guidance says patients who are unable to receive the drug from the trial site may purchase the commercially available product with a prescription from a local physician. The FDA says it would not consider this practice a violation of regulations against sponsors charging trial participants for an investigational drug and “would not object” to the sponsor reimbursing the patient for the cost.
In the rare circumstance of computer systems being rendered inoperable or inaccessible by the pandemic, sponsors can apply to the FDA for a short-term waiver of electronic document submission requirements. Technical difficulties with electronic transmission, however, should be referred to the agency’s electronic submission staff, the guidance says.
Read the guidance here: https://bit.ly/3esTQE0.