Information for Patients
What is Clinical Research?
Clinical research, also sometimes referred to as clinical studies or trials, is a branch of healthcare that is designed to determine safety and effectiveness of medications, devices, or diagnostic tools intended for human use. This is how healthcare develops and learns information about new and approved medications or devices.
Clinical Trials have four phases to test new treatments, find appropriate dosage, and learn about potential side effects.
Phase I
Testing in healthy participants to find appropriate dose range.
Phase II
Testing completed in patients to assess safety (side effects) and efficacy in a small population of patients; 100-300.
Phase III
Testing for efficacy, effectiveness, and safety (side effects) in a larger population of patients; 300-3,000.
Phase IV
Testing in post marketing/approval use for additional medication information on safety, efficacy, and effectiveness.
Why Do People Participate in Trials?
New Treatment Therapies
Some patients state that they will participate so that they have access to a new treatment that is not yet on the market or approved for their condition.
Benefits for Future Patients
Many of our patients tell us that they participate to help provide future patients with new medications or treatments for their condition.
Financial Benefits
Many trials offer patients the ability to manage conditions and see the study doctors free of charge. The new study medications are often also provided without any cost to the participants, which saves money from the standard medications they would have to purchase. Some trials also provide a monetary compensation for time spent at the clinic for study visits.
FAQs
All medications, including approved over-the-counter or prescription, have potential risks or side effects. All of the potential medication side effects or medical risks are detailed in an informed consent document. The informed consent document is reviewed with you prior to your decision to participate in the study. You are encouraged to ask any questions and have all of your concerns addressed prior to making any decisions to participate in the study. If you have additional questions or concerns during your study, you are always encouraged to discuss these with the study manager or any of the study doctors.
Each study will vary in length for the trial, number of visits, and duration of each visit. This information is detailed in the study informed consent document and will be discussed prior to your decision to participate.
Placebo is an inactive formulation of the medication being studied. Placebo is often used in clinical studies to compare the effectiveness to the new investigational medication. Patients will sometimes be randomized to receive a placebo medication and will be detailed in the informed consent for each study.
Yes. We encourage you to continue to see your primary optometrist/ophthalmologist and medical health care providers and to notify them of your decision to participate in the trial. It is also important that they are aware of your participation so that we can all ensure that any changes to your medications remain within the trial guidelines.
The study medication used in your trial will not be available after the study is complete, unless it is already approved by the FDA.
If you have another primary care physician, you should discuss treatment options with them after the study is complete. If you do not have a primary care physician and would like to continue to see our providers, we are happy to help make arrangements.
Yes. You may change your mind about the study after you have started; however, please inform our staff of your desire to end participation. Please also know that some studies still require follow-up activity(ies) to be completed.
Once you complete your current trial and if we have an additional study for your condition, you can request to see if you would be eligible for a new study. Please note that there is usually a 30-day waiting period between studies and you cannot be in more than one study at a time.
In order to determine if you are eligible for a study, you will need to complete a screening appointment. Once the screening appointment is complete, we will be able to tell you if you qualify for the study or if there is another study in which you would qualify. If you do not qualify for any of our current trials, we can add you to our research database and contact you when additional trials for your condition are available.
Still have questions?
As with anything new, we expect you would have questions. Our research team is happy to provide answers and peace of mind.
Interested in Future Studies?
Not seeing a study that fits your needs? Join our list to be notified about upcoming clinical trials and opportunities.
Meet the Research Team
Our dedicated research team combines clinical expertise with a patient-first approach, ensuring each study is conducted with precision, care, and integrity.
Dr. Bergstrom is a Fargo, ND native. Dr. Bergstrom is a graduate of the University of Minnesota School of Medicine and a Diplomat of the American Board of Ophthalmology. He is a member of the American Academy of Ophthalmology and the American Society of Cataract and Refractive Surgeons. He is also a Clinical Assistant Professor, Department of Surgery, at the UND School of Medicine and Fellow of the America College of Surgeons.
He started Bergstrom Eye Research as a Principal Investigator in 2013 and has worked on multiple ophthalmology trials due to his experience and expertise.
Tracie Teig Malsom, O.D. was born and raised in Marshall, MN. She attended Minnesota State University – Moorhead and graduated with honors with a Bachelor of Arts in Chemistry and Spanish. She went on to study for her doctorate at the Indiana University School of Optometry.
Dr. Malsom has served as an Investigator for Bergstrom Eye Research since joining our team in 2015.
Dr. Emily Heinrich is a recent graduate of the University of Missouri–St. Louis College of Optometry and is excited to return to her hometown of Fargo, ND to serve the Fargo-Moorhead community.
Angie has been an assistant in Ophthalmology since 2003. In 2017, she began focusing primarily on coordinating and managing eye related clinical trials and joined Bergstrom Eye Research in March of 2020. While she spent her elementary and teen years as a Moorhead Spud, she currently resides in North Fargo with her husband and son. Angie loves laughter, finding the humor in almost any scenario and listening to most types of music especially while soaking up the sunshine of summer days. She is currently working to develop interest in cold weather activities to make the long winters more bearable.
Brenda was born and raised in Fargo, ND and brings over 20 years of experience in Clinical Medical Research to our team! She shares a deep commitment to patient care and thoroughly enjoys meeting new people and learning about each and every person she is fortunate to encounter. Spending time with her children and their friends, laughing with her friends and making sure she escapes the cold each winter for a warmer climate are a few of Brenda’s favorite things.
Kristin is originally from Willmar, Minnesota. She attended Concordia College in Moorhead, MN and graduated in 1993 with a degree in Communications, French and English. She has gone to Haiti since 2017 with Dr. Bergstrom’s Haiti Eye Mission team and has become very passionate about the mission of preventing blindness. She is an active member of the Horace, ND community where she and her husband raised their son and still reside. In her spare time, she enjoys spending time with family and friends and relaxing at the lake.
Why Bergstrom Eye Research Center?
With decades of experience in eye care and a reputation for clinical excellence, Bergstrom Eye Research Center is uniquely positioned to deliver high-quality research while prioritizing patient experience.
Connected to an established eye clinic
Strong referral network
Experienced providers and staff
Commitment to innovation and patient care
Be Part of What’s Next in Eye Care
Whether you’re exploring treatment options or interested in contributing to medical advancements, our team is here to guide you.
