Re-adjudicating a respiratory and cardiovascular trial during COVID-19

A clinical trial on respiratory and cardiovascular events was nearing conclusion in early spring of 2020, and the escalating COVID-19 pandemic raised concerns that its endpoint data had been compromised by participants infected with SARS-CoV-2 during the trial. The FDA advised the trial to re-adjudicate so that the study accounted for the effects of COVID-19 on the trial outcomes. To ensure that the trial data would be submitted to the FDA as scheduled, ICON needed to coordinate re-adjudication of 700 endpoints within a compressed three-month timeline.

Developing and executing a condensed adjudication process that accounted for the impact of COVID-19 took a highly collaborative effort. ICON’s IDEA team worked with the clinical trial sponsor to streamline the contract negotiations and the acceptance of data specifications and form designs. Meanwhile, the adjudication committee members and ICON’s electronic adjudication system (EAS) vendor agreed to reduce turnaround times.

ICON’s comprehensive cloud-based EAS made it possible for ICON to implement new adjudication processes that accounted for COVID-19’s impact on endpoints, provide remote training, and manage end-to-end clinical events and endpoint adjudication workflows

The collaborative efforts of ICON and its partners successfully adapted the traditional adjudication processes for the extraordinary circumstances of COVID-19. The collaborative committee revised the charter, the adjudication forms and the adjudication platform to include the impact of COVID-19 on the trials’ endpoints ahead of the three month deadline.

Rapid implementation allowed for the near real-time collection of any positive COVID-19 tests incurred by participants during the trial. Re-adjudication with this information prevented multiple re-adjudications and trial delays. Database Lock (DBL) was submitted on time, with re-adjudicated endpoint data accounting for the impact of COVID-19 on trial participants. ICON’s experience enabled a compressed timeline for data review, and was a testament to the value of ICON’s expertise, systems and the flexibility and drive of collaborators under unforeseen clinical circumstances.