Developing a drug-device combination for patients with Parkinson's disease during the COVID19 pandemic
Movement Disorders Clinical Practice
; 9(SUPPL 1):S29-S30, 2022.
Article
in English
| EMBASE | ID: covidwho-1925966
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.
Full text:
Available
Collection:
Databases of international organizations
Database:
EMBASE
Language:
English
Journal:
Movement Disorders Clinical Practice
Year:
2022
Document Type:
Article
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