Partners in Nephrology and Endocrinology conducts clinical trials and works with industry leaders including Novo Nordisk and Eli Lilly on the development of medications to treat Type 1 diabetes and Type 2 diabetes.
Dr. Patricia Lynn Bononi, MD, FACP has been conducting clinical trials at PINE for over 8 years.
Melissa Bain, RN serves as the Research Coordinator for clinical trials at PINE.
Below are the answers to some frequently asked questions about clinical trials at PINE:
- What is a clinical trial?
- What are the benefits of participating in a clinical trial?
- Should I participate in a clinical trial?
- Who approves clinical trials?
- What clinical trials are currently ongoing at PINE?
- What is it like to participate in a clinical trial at PINE?
What is a clinical trial?
Clinical trials are carefully designed research studies that evaluate new treatments for diseases such as Type 2 diabetes. They are based on rules and guidelines known as “protocol.” The protocol describes what type of patients may particpate in the clinical trial, schedules of tests and procedures, drugs and dosages, and the length of the study.
Before new drug therapies are approved, they must be proven to be both safe and effective by the U.S. Food and Drug Administration (FDA). A new drug goes through three phases of clinical trials where volunteers are given study medical under close supervision of a doctor:
Phase I: Testing in a small group of people (20-100) to evaluate a drug’s safety, dosage, and potential side effects.
Phase II: Testing in 100-500 people to further evaluate a drug’s safety and effectiveness.
Phase III: Testing in 1,000-5,000 people to confirm a drug’s effectiveness, monitor side effects, and compare it to other approved treatments.
What are the benefits of participating in a clinical trial?
People volunteer for a number of reasons to participate in a clinical study:
- Advance science for more effective treatments to help others
- Benefit from potentially new treatment approaches for their disease condition
- Access better or more regular medical care
- Receive some or all medications free of charge
Should I participate in a Clinical Trial?
Clinical trials certainly have the potential to benefit you. It is important, though, to talk to the doctor about the potential risks that may be involved in a particular clinical trial as well. Discussing the benefits and risk of a clinical trial is part of the “Informed Consent” process, which helps protect you, the potential volunteer.
Researchers must provide a full written description of the clinical trial for you to read and sign before you agree to participate in a clinical trial.
Studies show that most clinical trial volunteers have a positive experience because they are not only helping themselves, but more importantly, are helping others by contributing towards the development of new treatments for diseases such as Type II diabetes.
All study medication and related care (physical exams and blood tests) are provided at no cost to participants.
Who approves clinical trials?
Visit www.clinicaltrials.gov to find the approved study information.
What clinical trials are currently ongoing at PINE?
Do you have Type 1 Diabetes? We are conducting PRONTO-T1D research study that determines if an investigational mealtime ‘ultra-rapid’ insulin helps control the blood sugar level of people with Type 1 Diabetes. We are seeking adults with Type 1 Diabetes who are currently using multiple daily injections of insulin. Qualified participants will receive study-related care and investigational medication from at no cost, and will receive compensation for their time. Please contact Melissa Bain, RN at firstname.lastname@example.org or by phone at 412-894-2444.
Do you have Type 2 Diabetes? A research study, PRONTO-T2D sponsored by Eli Lilly and Company is now underway to evaluate an investigational, mealtime Ultra Rapid Insulin, and study participants with Type 2 Diabetes are needed. This study is evaluating how well the investigational Ultra Rapid Insulin controls blood sugar after meals. We are seeking adults with Type 2 Diabetes who are currently using multiple daily injections of insulin. Qualified participants will receive all study related care and study medication at no cost. Compensation will also be provided. Please contact Melissa Bain, RN at email@example.com or by phone at 412-894-2444.
What is it like to participate in a clinical trial at PINE?
All patients in clinical trials are carefully monitored by a RN and MD and all study medications and related care during the study are provided at no cost to the patient.