Abstract Details

Title Ensuring the Continuity of Data Collection in a Focal Epilepsy Clinical Trial During the COVID-19 Pandemic

Topic Epilepsy/Clinical Neurophysiology (EEG)

Presentation(s) P2 - Poster Session 2 (11:45 AM-12:45 PM)

Poster/Presentation
Number 10-007

Objective

To ensure continuity of quality data collection by implementation of novel data capture measures whilst conducting an epilepsy clinical trial in the COVID-19 pandemic.

Background

The COVID-19 Pandemic introduced unprecedented complexities in conducting clinical trial assessments at required timepoints via traditional participant visits to clinical sites. Implementation of novel approaches mid-stream to maintain continuity of care for trial participants and satisfy the objectives of the protocol were required. In an ongoing Ph 2 trial in patients with focal epilepsy¹, mitigations to allow remote collection of data were implemented due to restrictions related to COVID-19.

Design/Methods Based on trial objectives and key data collection timepoints, a protocol assessment determined which visits could be performed remotely. Specific methodology was applied to determine which assessments could be captured remotely via traditional telemedicine. Vendors were evaluated to support remote capture of datapoints not captured via telemedicine, and modifications were subsequently made to the protocol, informed consent form, and trial database. Relevant materials were submitted for IRB, regulatory authority, and ethics committee approval.

Results After IRB, regulatory authority and ethics committee approvals were received, modifications to data collection due to interference related to the COVID-19 pandemic included the introduction of home health care providers to collect lab draws and vital signs at participants’ homes, Direct to Patient shipment of study drug, remote ECG collection, and allowance for scales to be conducted via telemedicine. Trial participants are consented to the use of these forms of data collection at their screening visit, and mitigations were successfully implemented across trial sites.

Conclusions

To ensure continuity of trial participant care, quality data collection, and the prevention of lost trial data due to COVID-19 complications, modifications to allow remote capture of data were successfully implemented in an ongoing Ph 2 trial in patients with focal epilepsy.

Authors/Disclosures
Lilly Frohlich, MPH (Cerevel Therapeutics) PRESENTER	Ms. Frohlich has received personal compensation for serving as an employee of Cerevel Therapeutics.
	No disclosure on file
	No disclosure on file
Rachel Gurrell, PhD (Cerevel Therapeutics)	Dr. Gurrell has received personal compensation for serving as an employee of Cerevel Therapeutics. Dr. Gurrell has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Cerevel Therapeutics. Dr. Gurrell has stock in Pfizer Ltd.
Ann Dandurand (Cerevel)	No disclosure on file
	No disclosure on file
Matthew Leoni, MD, MBA (Otsuka Pharmaceutical Development & Commercialization)	Dr. Leoni has received personal compensation for serving as an employee of Cerevel Therapeutics.

��ɫ��

��ɫ��