Among the multiple proposals for stimulating drug development and revising regulatory processes, the 21st Century Cures initiative includes several provisions designed to streamline clinical research and the amount of data required to gain FDA approval of certain indications.
Demands from patient advocacy groups for broader subgroup representation in clinical trials has generated a new drug trial transparency initiative at the Center for Drug Evaluation and Research (CDER).
TransCelerate recently announced a new initiative focused on eLabeling in clinical trials. The eLabels Initiative is expected to improve label usage for patients, streamline labeling approaches at sites and create opportunities to decrease timelines in the investigational supply chain resulting in cost efficiencies for sponsors.
With the clinical trial industry’s focus on improving monitoring efficiency and leveraging a variety of risk-based monitoring (RbM) models, novel eClinical technologies are emerging to facilitate clinical trial monitoring productivity.
While some countries are more progressive in approaching this challenge by virtue of mandatory, free of charge, molecular testing on all patients, this varies greatly in other countries based on institutional policy and insurance reimbursement.
In a move designed to both tout the importance of precision and to improve the sponsor experience in conducting cardiac safety assessment, iCardiac Technologies announced a full risk-sharing program for Thorough QT studies.