Case Study: SIB Monitoring in C-SSRS

GLOBAL BIOTECH LEVERAGES PATIENT-REPORTED SUICIDALITY ASSESSMENT TO SAVE LIVES AND OPTIMIZE COMPOUND INVESTMENT


ERT’s exclusive patient-reported eC-SSRS and eCOA solutions rapidly detected suicidal ideation and behavior (SIB).


SITUATION

During clinical development, sponsors and CROs need to detect possible suicide ideation and behavior (SIB) related to their drug in the screening, baseline, treatment and follow-up phases of their study. Suicidal ideation and behaviors are a threat to patient and drug safety, and as such, need to be assessed accurately and in a timely manner.

Data collected during suicide risk assessments will either indicate that the drug has no impact on SIB or that it increases or decreases the risk of suicide — providing the evidence required to terminate trials early, reducing cost and potentially saving lives.

In this group of trials for a multinational biotech company, SIB events occurred, including completed suicide. As a result, the FDA required prospective suicidal risk assessments to be added to their active studies.

SOLUTION

The biotechnology company chose ERT’s electronic C-SSRS—a unique monitoring solution which enables patients to self-report their symptoms.

In addition, real-time alerts were built in to ERT’s web and phone solutions which notified site staff, caregivers and supervisors to any positive results. When ERT’s eCOA tablets were chosen, alerts were in near real-time, based on data transmission to ERT’s EXPERT platform.

Finally, the solution enabled study monitors to access intra-study SIB trending analyses as well as insights across studies in other regions.

IMPACT

ERT provided the FDA and biotechnology company with evidence of a SIB risk associated with the treatment. The trial was then terminated early—potentially saving further lives.

“Enabling patients to self-report helped our client identify treatment-emergent suicide ideation and behavior more quickly and more accurately than would have been possible with clinician-led interviews,” commented Dave Elario, EVP eCOA.

In addition, any positive scoring on an assessment was sent to clinicians in real-time or near-real time, enabling them to act faster than would otherwise have been possible.

By implementing ERT’s patient-reported eC-SSRS solution, the sponsor—and investigative sites—also mitigated the burden / cost of administering clinician interviews during each site visit.

Giving patients the ability to self-report led to more accurate data than would have been possible with both paper and electronic clinician-reported suicide risk assessments. Adding patient reported electronic assessment to all active studies did not impose any patient burden—with 98% of all patients completing each assessment in four minutes or less.

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