Achieving Successful FDA Medical Device Clinical Trials

An in vitro medical device which has the capability to deliver breakthrough technology to the advancement of understanding cancer metastasis requires a platform to bring preliminary feedback to the FDA. The scientists (creators of the device) have worked with thousands of tissue bank samples and have confidence that their discovery can identify pathways for cancer metastasis in all cancers. The challenge is to take this broad usage and narrow down specific populations within cancer types in order to acquire device approval, one cancer type at a time.

RQMIS and the Sponsor agree assigning the label of clinical “application” vs. clinical study is the best approach to reach clinical sites and also appeal to the FDA request for more information. Coining this project, a clinical application allows it to take the shape of a clinical study with a few fewer steps.

In this highlight, we feature an in vitro device, which is in-laboratory. The device is not transferred to the clinical site, there is no contact between the device and the patient, and no patient follow-up. This application takes FDA questions and discussions and provides a structure for the response.

Goals of the Sponsor: Due to the enormity of cancer, the challenge for the Sponsor is to bring the discovery to use within small cancer populations, allowing clinicians to evaluate the clinical usage and consider how surgical protocols might adapt with the goal of improving treatment strategies.

Goals of RQMIS: To acknowledge the clinical development team goal (Sponsor) while customizing an application submission packet that falls within the site's regulatory steps while streamlining tissue acquisition to result in usage approval per cancer type.

RQMIS assumed the role of clinical manager. First steps:

• Identify sites
• Network to establish appropriate surgeons and clinical teams
• Determine key players for contracts, Institutional Review Board (IRB), and tissue acquisition
• Provide oversight on tissue collection, shipment, and result delivery

The challenge with each site was to provide a protocol, budget, and Clinical Trial Agreement that fit the nature of the no-risk study. Each conversation with the site required a thoughtful approach to deliver the clinical schematics of the survey while conveying the aggressive timeline of the Sponsor to deliver clinical usage results to the FDA.

RQMIS developed a unique study application, resulting in:

• Abbreviated clinical protocol
• Pathway to link the clinical study to the hospital-approved surgical consent
• Designing a clinical application agreement in place of a clinical trial agreement
• Creating a laboratory reference manual that would serve as a cheat sheet within both the OR and the clinical site laboratory

RQMIS took considerable time to build relationships with the clinical team and communicate directly with the surgeons. This laid the groundwork for approvals among departments to promote the turnaround of patient tissue to laboratory analyses and Sponsor results and drive home the critical endpoint - a collection of Clinical Usage to the FDA.