FDA Adds Questions and Answers to Coronavirus Clinical Trial Guidance

The FDA has updated its guidance on conducting clinical trials during the COVID-19 pandemic with an extensive Q&A section, including a long list of factors to consider when deciding the status of ongoing trials and ones soon to be initiated.

Patient safety is the most important factor to consider when deciding whether to suspend or continue a trial already in progress or to initiate a new study during the national health emergency, the FDA said. In the newly added Q&A section, the agency recommends certain assessments sponsors should make in making such a decision, including:

• Assessing whether limitations created by the pandemic on protocol implementation pose new safety risks to participants, and whether the risk can be practically mitigated by amending study processes and/or procedures;
• Weighing whether the clinical investigator/sub-investigators will be continually available to oversee the trial and assess/handle safety issues that arise;
• Determining if there will be enough trial support staff on hand and adequate equipment and materials available to them;
• Considering whether clinical investigator sites will remain open to participants for required in-person assessments or whether the investigator has the ability to give required in-person assessments at an alternative location(s), or whether the assessments can be done virtually;
• Evaluating the continued availability of trial supplies and continued operations of vendors, especially related to the investigational product and supplies essential to maintaining safety monitoring and other key trial procedures;
• Assessing if IRB, IEC and Data Monitoring Committee staff will continue to operate, and if there will be adequate communication with them to support trial needs;
• Weighing public health measures that may be in place by federal and state authorities for the coronavirus, and if they could impact the trial.

“Given the evolving situation, with likely increasing impacts on investigators, staff, and supply chains, sponsors should carefully consider the ability to effectively mitigate risks such that patient safety and trial integrity are assured,” FDA said.

The agency noted that the risks and benefits of keeping a trial going are likely different than those involved in initiating trials other than ones evaluating COVID-19 treatments and vaccines.

The Q&A section also expands on how sponsors should manage protocol deviations and amendments made to trials in response to the pandemic. For example, if visits are to be conducted by telephone or video contact rather than at the investigational site as originally specified in a study’s protocol, the agency said it would be acceptable if the sponsor created documentation listing all study visits (study reference number, patient ID and date of visit) that deviated from the protocol.

The agency acknowledged that there will most likely be delays in on-site monitoring of clinical trials during the pandemic and advised sponsors to find alternative ways to maintain trial participant safety and data quality/integrity, such as by enhancing central monitoring, contacting sites by telephone to review study procedures, participant status and study progress, or remotely monitoring individual participants when viable.

In addition, it touches on home delivery and infusion of investigational products in certain situations and how to obtain a signed informed consent form from an isolated patient, among other topics.

Read the guidance here: www.fdanews.com/03-30-20-ConductClinicalTrialsQA.pdf. — James Miessler