MIAP Offers Assistance to Investigators for Streamlined FDA Submissions as COVID Research Ramps Up
As the coronavirus pandemic began spreading to the U.S., the U-M research community responded with many innovative ideas to treat patients, prevent infections, and address shortages of medical products. MICHR’s IND/IDE Investigator Assistance Program (MIAP), which supports investigator-initiated clinical trials with FDA submissions, became the first stop in the research project lifecycle for COVID-19 research ideas involving drugs or devices.
MIAP has met with many teams across the research enterprise as they test different compounds to treat the virus and the resulting immune storm, developing plans for low-cost ventilators consisting of off-the-shelf parts, or 3D printing devices to allow one ventilator to be shared between two patients with different breathing needs.
These consultations have often resulted in MIAP assistance developing and submitting protocols, interacting with the new FDA Coronavirus Treatment Acceleration Program (CTAP), and understanding the changes to regulation due to the public health emergency. CTAP is a new emergency program that allows for possible therapies and treatments to reach patients as quickly as possible. As of May 15, CTAP has allowed for about 150 active trials related to COVID-19, with more than 500 in the developing and planning stages. More information on CTAP is available on the FDA website.
“We’re proud to help investigators move their ideas into human clinical trials, and from those trials, to help safe and efficacious new treatments become available to patients everywhere,” said Jeanne Wright, MIAP program director at MICHR. “MIAP touches a fascinating variety of initiatives as a result of our diverse expertise in drugs and devices.”
Have questions about regulatory assistance for investigational drugs or devices? Learn more by visiting the MIAP services page.