6/29/2021
Photo by Adeolu Eletu on Unsplash
The US Food and Drug Administration (FDA) released a draft guidance “Sponsor Responsibilities - Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies.” The draft guidance is a combination of the final guidance from 2012, “Safety Reporting Requirements for INDs and BA/BE Studies” and an updated version of the draft guidance from 2015, “Safety Assessment for IND Safety Reporting,” which has been withdrawn. The intent of the draft guidance is to clarify and support sponsors in understanding the requirements for expedited safety reporting.
This guidance provides 1) definitions for terminology used in safety reporting, 2) recommendations for when and how to submit safety reports, 3) information about other reporting issues sponsors have raised, and 4) recommendations for the two Investigational New Drug (IND) safety reporting requirements that use aggregate data assessment. Applicable to a drug or biologic clinical trial, IND safety reports are made when there is an individual case of a serious adverse event (SAE) in a study participant or aggregate analysis of SAEs that indicate they are more frequent in the treatment group.
The portion of the 2015 draft guidance was updated based on the feedback the FDA received. Under the 2015 draft guidance, one item that rose the most concern was that sponsors were to create safety assessment committees (SAC). Their role was to review safety information and to make a recommendation to the sponsor if the information met the IND safety reporting criteria. Then, the sponsors were to report potential serious safety risks within 15 calendar days if they confirm the SAC information qualified for an IND safety report. Thoughts were that this reduced the operational flexibility of sponsors’ existing internal safety monitoring processes that are more specific to the investigational product. The new draft guidance allows the sponsor to choose which individual or group is responsible for IND safety information review and reporting recommendations.
Other updates to the 2015 draft guidance include:
planned unblinding of safety data and implications for trial integrity,
clarification on the scope and methodology of aggregate analyses, and
clarification on the safety surveillance plan and which elements to include.
This draft guidance does not include any of the recommendations to investigators from the 2012 guidance. However, a new draft guidance focused on investigator responsibilities for IND Safety reporting is planned. Until both draft guidances become finalized, the 2012 guidance remains in effect.
Do you feel the new draft guidance addresses concerns raised by the 2015 draft guidance? Submit your comments through September 24, 2021 HERE.
- The Clinical Pathways Team
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