ABSTRACT
Objective: To describe the challenges of developing a drug-device combination for patients with Parkinson's disease (PD) during the COVID19 pandemic. Background: 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 extensive face-to-face support and monitoring. Methods: A COVID19-Taskforce was established to rapidly adapt study execution strategies and tactics, balancing patient safety with good study practice under the extraordinary conditions imposed by the pandemic. Results: A risk assessment led 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 addressed the difficulties in conducting virtual visits in countries with limited network infrastructures. 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. 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. Conclusion: 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.