About Rochester General Hospital's Center for Clinical Research
Our Clinical Research program is committed to advancing medical knowledge and improving patient outcomes through innovative studies and trials. We provide opportunities for patients and professionals to participate in research that shapes the future of healthcare. At Rochester General Hospital’s Center for Clinical Research, our team focuses on delivering high-quality, ethical research tailored to the needs of the Greater Rochester community.
From industry-sponsored trials to investigator-led studies, we strive to bring new treatment options closer to home while advancing specialties such as cardiovascular, surgical, and pulmonary medicine, and supporting education and compliance throughout the process.
Current Trials and Studies
- ALLAY HFrEF - Evaluates the safety and effectiveness of the ALV1 System for heart failure with reduced ejection fraction.
- ALLIANCE AVIV - Tests the SAPIEN X4 Transcatheter Heart Valve for patients with a failing aortic bioprosthetic valve.
- AURORA-HFpEF - Assesses the safety of MYK-224, an investigational drug for heart failure with preserved ejection fraction.
- CARVTOP ICD - Compares outcomes of carvedilol versus metoprolol succinate in patients with implantable cardioverter-defibrillators and heart failure.
- CHAMPION AF - Determines if Left Atrial Appendage closure with the WATCHMAN FLX™ Device is an alternative to blood thinners for patients with atrial fibrillation.
- CLASP II TR - Evaluates the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System for tricuspid regurgitation.
- EARLY TAVR - Studies whether aortic valve replacement is helpful for patients who have a narrowing of the aortic heart valve in which calcium has attached to the valve surface.
- EMPOWER - Assessment of the Carillon Mitral Contour System® in Treating Heart Failure with Functional Mitral Regurgitation
- LEVEL - Assesses whether levosimendan improves the distance participants with heart failure with preserved ejection fraction can walk in 6 minutes.
- LEVEL 2 - Assess whether levosimendan, compared to a placebo, improves the distance participants with heart failure with preserved ejection fraction can walk in 6 minutes.
- PROGRESS - Evaluates SAPIEN 3™, SAPIEN 3 Ultra™, and SAPIEN 3 Ultra RESILIA™ Transcatheter Heart Valve for calcific aortic stenosis treatment.
- REBALANCE HF - Evaluates the safety and benefits of single‑side ablation of the greater splanchnic nerve (GSN) in people with HFpEF.
- REFORM HF - Tests the AquaPass System in patients with decompensated heart failure and persistent fluid overload.
- RELIEVE HF - Evaluates the safety of the V-Wave shunt and how well it works in helping heart failure patients.
- REPAIR MR - Evaluates the use of the MitraClipTM system in patients with severe primary mitral regurgitation who are at moderate surgical risk.
- SYNCHRONICITY - Studies the safety and effectiveness of left bundle branch area pacing in patients with heart failure.
Interested in learning more or enrolling in a trial?
- Food Allergy Biobank - Studies proteins that cause allergic reactions and immune molecules and cells in blood to develop better detection, diagnostic or therapeutic agents for food allergies.
- Home Peanut Oral Immunotherapy - Determines the safety and satisfaction of up-dosing encounters for peanut oral immunotherapy.
- IgE Mediated Food Allergy - Tracks choice of food allergy management in individuals over the age of 1 with IgE mediated food allergy.
- DACAT - A study to improve cephalosporin allergy testing and to determine what causes cephalosporin allergy.
- Telemedicine for Penicillin Allergy Testing in Pregnancy - A study to improve evaluating telemedicine-facilitated amoxicillin challenges in obstetric offices for pregnant patients with low-risk penicillin allergy.
- Management of Chronic Spontaneous Urticaria - A study to to track choice of therapy & reasons for therapy selected in all individuals over the age of 18 with uncontrolled Chronic Spontaneous Urticaria seen in our office.
- PMR Outcomes and SGLT2 Inhibitor Use - Retrospective review comparing outcomes in patients with PMR treated and not treated with SGLT2 inhibitors.
Interested in learning more or enrolling in a trial?
- Mepolizumab - Understand how well the medication mepolizumab (NUCALA) is working in routine medical practice to treat severe asthma patients who have an eosinophilic phenotype (SA-EP).
- AIM4 - Determine which regimen is more effective: taking dupilumab with an inhaled asthma study drug or only taking a higher dose of the inhaled asthma study drug.
Interested in learning more or enrolling in a trial?
- AROMA - Understand the characteristics of patients who receive DUPIXENT for Chronic Rhinosinusitis with Nasal Polyposis and the treatment patterns.
Interested in learning more or enrolling in a trial?
Our research team is here to answer your questions and guide you through the enrollment process. Call us today to speak with a coordinator and take the first step toward participating in a clinical study.
Clinical Trial FAQs
Clinical research translates basic science and discoveries into safe and effective tests, drugs, devices and procedures, eligible for approval by the U.S. Food and Drug Administration (FDA). Clinical trials are carefully designed and monitored studies intended to test and evaluate investigational drugs and treatment plans.
Many participants are patients whose own illnesses are not responding to standard treatment, and who hope that the study treatment – possibly an investigational drug, a device, or a combination of drugs or devices – will work better than standard therapy.
Other participants are healthy people who want to contribute to medical science and to help doctors and researchers find better ways to treat others’ illnesses.
Researchers follow strict ethical and scientific principles to ensure that patients are protected and that the results produced are valid. The study’s sponsor – a drug or device company – will draft a plan of how the study will proceed. This plan, or protocol, specifies how many individuals will be enrolled, how much drug will be used and when, what medical tests will be provided, and so on.
Evaluating new treatments involves some risks. Using a small group of volunteers, Phase I trials determine the best dosing and identify side effects. After a drug is shown to be safe and well-tolerated, Phase II and Phase III trials provide treatment to a larger numbers of patients with a specific disease. Side effects can vary, with dangerous complications possible.
To ensure that participants are not be exposed to unreasonable or unethical risks, every protocol is reviewed and approved by the sponsoring organization as well as an Institutional Review Board (IRB), which consists of health professionals, clergy and other community members. At Rochester General, the Office of Human Research Protection fulfills the IRB role.
Your doctor’s referral is not necessary, but anyone seriously considering a trial is urged to talk with his or her doctor and family about the potential benefits and risks. In order to participate, you will be evaluated by the medical staff conducting the study to determine whether you meet the medical criteria.
If you’re approved to join a trial, you should continue seeing your regular physician. Trial coordinators will consult with your doctor about how the study’s therapies are impacting you.
In most cases, the drugs and devices used, and any procedures for the study such as blood work, urine samples, x-rays and travel expenses are provided free to participants. Other costs unrelated to the trial may be covered by the patient’s insurance company or Medicare. Be sure to get a full accounting of costs before committing to a trial.
Each phase of clinical research is designed to gather specific information about the study drug, device or treatment.
Phase I
A Phase I trial is designed to determine the best dose of the investigational drug and to identify any potential side effects. Because a Phase I study represents the first time an investigational drug or therapy is being used on humans, the risks can be significant. Such trials typically involve a small number of volunteers.
Phase II
Begun after an investigational treatment is initially shown to be safe and well-tolerated, aPhase II trial studies how well the treatment works, usually in a larger group of patients. Early- and late-stage Phase II trials may be called Phase IIA and Phase IIB.
Phase III
Phase III trials examine how well the drug or therapy works in hundreds or many thousands of patients. In this phase, the study drug may be compared to an existing standard treatment. Early- and late-stage Phase II trials may be called Phase IIIA and Phase IIIB.
Phase IV
After a drug has been approved by the U.S. Food and Drug Administration and marketed, Phase IV trials – typically involving a large number of participants – may evaluate new uses of existing therapies or be used to detect side effects that did not appear during Phase III.
The National Institutes of Health guides potential participants in deciding whether to participate, and encourages that individuals ask the following questions:
- What is the purpose of the trial?
- What kind of tests and treatments are involved?
- What is likely to happen in my case with, and without, this new research treatment?
- What are alternative treatment options and their advantages and disadvantages?
- How might this trial affect my daily life?
- What side effects might I expect from the study?
- How long will the trial last?
- Will hospitalization be required?
- If I were harmed as a result of the trail, what treatment would I be entitled to
- What type of long-term follow-up care is part of this study?
The following organizations provide additional information:
- Food and Drug Administration Consumer Health Information
- The Center for Information and Study on Clinical Research Participation (1-888-CISCRP3)
- ClinicalTrials.gov – a registry of federally and privately supported clinical trials currently being conducted in the United States and around the world
- VeritasMedicine.com – the source for some of the above questions and answers
Our Research Team
Julie graduated from Monroe Community College with an Associate Degree in Nursing and State University of NY at the College of Brockport with a Bachelor of Science Degree in Nursing. Julie worked at a few local hospitals as a staff nurse before finding a career in research. Julie worked at Rochester Clinical Research as a study coordinator, senior coordinator, and study manager for over 10 years. She holds certifications in numerous research databases including training in C.I.T.I, GCP, Biohazardous shipping, and BLS. She earned her CCRC in 2016. She joined the Center for Clinical Research team in March of 2025.
Kari has over 20 years of experience as an Administrator in the research realm, including immunological grant studies and sponsored studies. She is responsible for budgeting, data collection, invoicing, spreadsheets, and management of day-to-day operations. Kari is C.I.T.I, GCP certified and trained in CareConnect clinical research functionalities. Kari brings a wealth of knowledge to our growing research team.
Kara graduated from Monroe Community College with an Associate Degree in Nursing. Kara worked at a local hospital as a staff nurse, as a Community Health Nurse/Case Manager, and in a Dialysis center before finding a career in research. Kara worked at Rochester Clinical Research as a study coordinator for over 2 years. She holds certifications in numerous research databases including training in C.I.T.I, GCP, Biohazardous shipping, and BLS. She joined the Center for Clinical Research team in November of 2020.
Kelly graduated from Mohawk College in Hamilton, Ontario with an Associate Degree in Nursing and completed her Bachelor of Science Degree from Wilmington University in Newark, Delaware. Kelly worked in Hamilton, Ontario before accepting a Travel Nurse position to Philadelphia, PA. Kelly had an assignment in Pharmaceutical Phase I Clinical Research where she remained Per Diem for 16 years. Kelly worked at St. Christopher’s Hospital for Children in Philadelphia as a Cardiac Intensive Care Nurse and then as the STS Congenital Surgical Database Manager. Kelly joined the Center for Clinical Research at Rochester General Hospital in 2022. She holds Certification in numerous Research Databases, C.I.T.I, GCP, Biohazardous Shipping and CareConnect clinical research training and implementation. She brings with her the background knowledge of Cardiac Critical Care and Data Collection.
Kathleen came to nursing as a second career after working in healthcare finance. She graduated from St. Louis University and worked at Vanderbilt Medical Center before relocating to Rochester. She returned to school and graduated from the Monroe Community College nursing program. She worked at Episcopal Senior Life Communities on the rehabilitation unit and as clinical coordinator on the dementia and hospice unit. She then spent 14 years at Rochester Clinical Research as a study coordinator, senior coordinator, and study manager, specializing in therapeutic trials with an emphasis on behavior modification. She holds certifications in numerous research databases including training in C.I.T.I, GCP, Biohazardous shipping, and BLS. She earned her CCRC in 2018. She joined the Center for Clinical Research in January of 2026.
Megan graduated from West Valley College with an Associates in Liberal Arts, a Bachelor of Science in Psychology from San Jose State University, and an Associates of Applied Science in Nursing from Tompkins Cortland Community College. She has experience as a staff nurse on Newark-Wayne Community Hospital’s Med-Surg Unit, and in the OR as a Circulating Nurse. Megan comes to our team from Rochester General Hospital’s CTICU, where she has worked as both a staff and charge nurse, recovering patients from complex open heart surgeries and precepting new staff. She holds certifications in numerous research databases including training in C.I.T.I, GCP, Biohazardous shipping, ACLS, and CareConnect clinical research training and implementation. Megan’s critical care background and leadership skills make her a valuable addition to our research team.
Dawn graduated from the State University of NY at the College of Brockport with a Bachelor of Science Degree in Nursing. Dawn worked for a short time as a staff nurse at Genesee Hospital on the cardiac floor before finding her passion at Rochester Regional Health’s (RRH) Allergy, Immunology and Rheumatology (AIR) clinic where she has been for 15 years. She started as a staff nurse and worked up to lead nurse, then over-seeing all AIR, Dermatology and Endocrinology offices in the RRH system. She joined the Center for Clinical Research Team in February of 2019 and hasn’t looked back since. She holds certifications in numerous research databases including training in C.I.T.I, GCP, Biohazardous shipping, BLS and CareConnect clinical research training and implementation. With her background in Asthma and Allergy, she brings a particular wealth of knowledge to Asthma, Allergy, Immunology & Rheumatology trials at the AIR clinic.
Linette graduated from Genesee Community College with an Associate Degree in Nursing. Prior to becoming a Registered Nurse, Linette was a Licensed Practical Nurse where she worked for a short time at Urgent Care before finding a career at Rochester Regional Health’s (RRH) Allergy, Immunology and Rheumatology (AIR) clinic. She started as a staff nurse and worked up to lead nurse while also moving through the clinical ladder to become a Clinical Ladder RN III. She joined the Center for Clinical Research Team in June of 2023 and is enjoying all there is to learn about Research. She holds certifications in numerous research databases including training in C.I.T.I, GCP, Biohazardous shipping, and BLS. Having a background in Asthma and Allergy, provides for an easy transition into the Asthma, Allergy, Immunology & Rheumatology trials at the AIR clinic.
Holly has been with Allergy, Immunology, and Rheumatology at RRH since September 2013. She started working part time in research in 2016 and switched to full time research in 2021. She is a Licensed Practical Nurse in New York State. She holds certifications in numerous research databases including C.I.T.I Program in Good Clinical Practice, Research Coordinators, Conflicts of Interest, Shipping and Biohazardous Material, Conflicts of Interest and Commitment, COI in Healthcare, Biomedical Sciences, Responsible Conduct of Research. She conducts research study visits per protocol.