Early Phase Clinical Trials Program

Unparalleled collaboration opportunity

The Early Phase Clinical Trials Program provides external industry study sponsors with guidance, resources and project management to quickly and effectively launch early phase clinical trials for cardiovascular diseases.

By collaborating with us, industry sponsors gain access to Mayo Clinic's wealth of expertise and resources.

The Early Phase Clinical Trials Program opens opportunities for both patients and health care professionals to participate in cardiovascular clinical trials with some of the newest medicines, biologics and devices available. The program is part of the Department of Cardiovascular Medicine at Mayo Clinic in Rochester, Minnesota. All trials conducted through this program are based in Rochester, with the opportunity to also expand to Arizona and Florida and our Mayo Clinic Health System sites.

Mayo Clinic offers care for both common and rare diseases, reaching a broad population of patients who may be interested in participating in early phase clinical trials. The Department of Cardiovascular Medicine in Rochester sees more than 100,000 patients from around the world every year. Across all sites, Mayo Clinic provides care for more than 1 million patients every year.

Mayo Clinic works with a variety of industry sponsors to participate in early phase clinical trials. For drugs and biologics, these are phase 1 or phase 2 trials. For devices, they include pilot or early feasibility trials.

Expedited services

The Early Phase Clinical Trials Program has dedicated resources to facilitate and accelerate the clinical trials startup process. Our goal is to open clinical trials for patient enrollment 4 to 6 months after we receive all the required documentation from the industry sponsor.

Our accelerated clinical trial activation process has four stages. A project manager from our program oversees progress through each stage to ensure regular communication and prompt action.

Stage 1: Sponsor document collection

In this stage, the industry sponsor submits the documents required for study assessment. We provide a complete list of the required documents.

Key documents include:

  • Final protocol.
  • Informed consent.
  • Budget and contract templates.
  • Investigational brochure or device manual.
  • Final lab, pharmacy and imaging manuals.
  • U.S. Food and Drug Administration (FDA) letter.
  • Patient information material.

Stage 2: Study assessment

In this stage, our experts assess trial feasibility, develop a budget and prepare the study for submission to the Mayo Clinic Institutional Review Board (IRB). Our study team actively communicates with you as they review your documents.

Assessments include:

  • Scientific review.
  • Accrual feasibility.
  • Personnel effort.
  • Procedural costs.

Stage 3: Study startup

In stage 3, our team obtains approvals for the IRB, budget and contract in parallel. These approvals have already been granted priority status within Mayo Clinic's shared services.

In addition, our study team begins the study startup, which includes:

  • Scheduling the site initiation visit.
  • Gathering regulatory documents.
  • Beginning setup with internal service areas.

Stage 4: Study setup

In this final stage, our program team completes site activation in preparation for participant enrollment.

The study team completes the setup, which includes:

  • Completing the site initiation visit.
  • Completing regulatory documents and training.
  • Obtaining the site activation letter.
  • Completing setup with internal service areas.

Program leadership

Atta Behfar, M.D., Ph.D.

Heart transplant specialist experienced in discovery and translation of biologics-based therapies, including cells and exosomes.

Horng H. Chen, M.D.

Heart failure specialist experienced in translational and early phase drug studies.

Mackram F. Eleid, M.D.

Structural and interventional cardiologist experienced in leading early phase device clinical trials.

Julie H. Byrne
Project Manager

Experienced facilitator specializing in oversight of the cardiovascular clinical trial startup process.