Clinical Trial Infrastructure

Consulting, advising, and implementing trials and studies needed for commercialization.
The MPDC is dedicated to helping pediatric products organize, navigate, and develop clinical trials ranging from small scale feasibility studies to full-scale national clinical trials. Through leadership at Cincinnati Children’s ACTION (Advanced Cardiac Therapies Improving Outcomes Network) group and Nationwide Children’s Center for Surgical Outcomes Research (CSOR), we aim to provide pediatric-specific guidance on clinical strategy, protocols, and execution to help ensure research and study outcomes effectively align with commercialization milestones.

Nationwide Children’s Center for Surgical Outcomes Research (CSOR)

Dr. Van Arendonk and his team at CSOR engage with device developers to advise on potential indications, target diseases and patient populations. The MPDC, working along with CSOR, facilitates systematic analyses to identify patients with the target conditions and the potential competitor devices currently being used.

We will also help innovators identify the type/location of institutions where these patients are treated to allow us to target appropriate partners to perform clinical testing both within the MPDC and nationally. We then help inventors develop a comprehensive hierarchical plan for clinical testing of the device, beginning with initial pilot studies, with plans to progress to larger clinical trials when indicated.

Cincinnati Children’s ACTION

Dr. Angela Lorts is the chief executive director and co-founder of ACTION. ACTION is a global network of pediatric stakeholders working to improve outcomes of patients, originally focused on patients and studies with heart failure. With the ACTION network, the MPDC seeks to provide all pediatric devices clinical and site access to over 70 national sites familiar with pediatric trials and studies.

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