FDA Asks Oncology Trials to Flag COVID-Era Remote Datasets
To learn more about the quality of data collected remotely during the pandemic, the FDA is asking oncology drug trials to voluntarily flag data collected remotely rather than onsite.
While there is currently no standard approach for identifying pandemic-related modifications to clinical trial datasets, the agency’s Oncology Center of Excellence said in a statement last week that differentiating between remote and onsite datasets can help researchers gain a better understanding of the potential impact of trial decentralization on data.
The center’s aim is to foster the use of decentralized trial aspects, including remote clinic visits, remote labs, remote imaging, remote administration of an investigational product and remote site monitoring. It noted that the use of full or hybrid decentralized trial designs has been rare in oncology, in part due to uncertainty about potential impacts on data quality.
Read the statement here: https://bit.ly/2OPDX2r.