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Abstract Details

Developing a drug-device combination for patients with Parkinson’s disease during the COVID19 pandemic
Movement Disorders
Movement Disorders Posters (7:00 AM-5:00 PM)
080
To describe the challenges of developing a drug-device combination for patients with Parkinson’s disease (PD) during the COVID19 pandemic.
ND0612 is a continuous, subcutaneous levodopa/carbidopa delivery system in development for patients with PD experiencing motor fluctuations. In this population, trials of drug-device combinations typically require several hours of in-person trainings, extensive face-to-face support and monitoring.
The conduct of two ongoing international, multicenter trials had the potential to be significantly impacted by the pandemic. A COVID19 Taskforce was established to rapidly adapt execution strategies and tactics to conduct these pivotal trials in safe and effective ways that balanced patient safety with good study practice under the extraordinary conditions imposed by the pandemic.
A risk assessment was immediately performed leading to a temporary protocol addendum; almost 70% of planned onsite study visits were given the option to be conducted virtually (with clear guidance), the rest (including screening) were deemed critical to continue in-person. Specific local tactics were developed to address the difficulties in conducting virtual visits in countries with limited network infrastructures and smartphone availability. Nurse-educator support visits at patient homes were partially replaced by virtual visits, and the nurse call center was extended to provide 24/7 patient support. Increased sponsor involvement, such as webinars and regional medical affairs support to study PIs, improved communications.  Study supplies (including investigational product) were sent directly to patient’s homes. In addition, personal protection equipment was provided where needed, and COVID19 testing was available for study monitors. 
The changes implemented were well-accepted by the investigators and patients and ensured patient safety while maintaining the integrity of this clinical trial. We found that clear and frequent communication, with a balanced ‘hybrid’ mix of virtual and in-person approaches, successfully enabled the safe continuation of pivotal clinical trials with this drug-device combination in patients with PD.
Authors/Disclosures
Ryan J. Case, PhD
PRESENTER 		Dr. Case has received personal compensation for serving as an employee of NeuroDerm.
No disclosure on file
Liat Adar (Neuroderm) Liat Adar has received personal compensation for serving as an employee of Neuroderm.
Osnat Ehrman (NeuroDerm) Ms. Ehrman has received personal compensation for serving as an employee of Neuroderm.
No disclosure on file