Clinical Research
Improving patient care is the goal of Beacon Medical Group Clinical Research. As one of the area’s most comprehensive research centers, Beacon Clinical Research is involved in studies that are developing medications and devices for a variety of health conditions.
Clinical research trials conducted by Beacon Medical Group Clinical Research provide many benefits to not just our patients but to our local and global community as well. Participating in a clinical trial may help patients who are not responding to standard health care options. Patients receive more time and oversight from a physician both at their visit times and between visits as well.
On average, only one compound in 1,000 will actually make it to human testing. For those investigational products or devices that make it to market, the study process was long, going from a Phase 1 (healthy volunteers) to a Phase 4 (post-marketing safety). BMG Clinical Research has participated in all five study phases and has contributed to bringing new health care options to our community.
For more information or to apply for a clinical trial contact Pamela Sims at 574.647.7883 or email psims@beaconhealthsystem.org.
You can view our current clinical trials below.
For Patients
What is a clinical trial?
The only way a new drug comes to market in the United States is after extensive human testing. A clinical or research trial is the process by which those human volunteers help contribute. Beacon Medical Group is our community’s resource for pharmaceutical and device research trials. To learn more about clinical trials, please visit ClinicalTrials.gov.
Who is eligible to participate in a clinical trial?
Volunteers are required to meet study criteria designed by the drug maker. The criteria make measurements of outcomes — good, bad or indifferent — possible.
Interested patients (volunteers) undergo a screening process that is tailored to that particular study protocol (study plan). The screening process begins the first time the individual speaks with the study nurse. The study nurse will ask a few key questions to see if they are eligible for the trial. Every study has a list of inclusion/exclusion criteria that a study volunteer (subject) has to meet in order to enroll in the study. If the volunteer meets the inclusion and is not disqualified by the exclusion criteria they will be scheduled for a visit with a research physician and study nurse. The first step at this initial visit is the informed consent process. The consent will contain a list of all known side effects and possible benefits of participating in the study. The consent also informs them that they are free to withdraw from the study at any time without any consequences. If the decision is made to participate in the study the subject may receive study procedures such as a physical examination and lab work.
All office visits, exams, labs, procedures and study drugs are provided at no cost to the volunteer. Volunteers are frequently reimbursed for travel and time commitment to the study.
Our Research Experience
We are proud to be in our second decade of performing clinical trials in our region. Care is provided by the physicians of Beacon Medical Group and an experienced staff of research registered nurses. Our staff also includes a regulatory and contracts specialist.
“Research is important to find out which treatments will be better for patients. Research has a crucial role in discovering new therapy, medications and treatments, and making sure that existing treatments is the best possible treatments we offer for our patients. Research can find answers to things that are unknown, filling gaps in knowledge and changing the way that healthcare professionals work. Some of the common aims for conducting research studies are to.”
“At Beacon Health, research trials are an everyday part of patients’ care. Patients being cared for benefit from past research, and continue to benefit from research that is currently being carried out. Ultimately, high-quality clinical research helps health care professionals to improve future healthcare.”
“Our research team are constantly raising awareness of the importance of clinical research to improve our patients’ quality of life of life.” –Dr. Ahmed Elmaadawi
We support a network of research sites to assure consistent quality, safety and compliance for the clinical trial process.
Areas of Clinical Research Expertise
- Cardiology
- Diabetes (Type 2 diabetes)
- High blood pressure (hypertension)
- Osteoarthritis
- Psoriasis
- Psychiatry
- Rheumatoid arthritis
Current Clinical Trials
Heart Failure Optimization Study (HF-OPT)
Primary Physician Investigator: John Kobayashi, MD
Contact: Joni Rousculp | 574-647-1593 | jrousculp@beaconhealthsystem.org
A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Injectafer® (Ferric Carboxymaltose) as Treatment for Heart Failure with Iron Deficiency
Primary Physician Investigator: John Kobayashi, MD
Contact: Julianne Havens | 574-647-3125 | jhavens@beaconhealthsystem.org
Vigilant ObservatIon of Gliadel Wafer Implant Registry (VIGILANT)
Primary Physician Investigator: Joseph Schnittker, MD
Contact: Vanessa De Pue | 574-647-6584 | vdepue@beaconhealthsystem.org
Long-term Antipsychotic Pediatric Safety Trial (LAPS)
Primary Physician Investigator: Ahmed Elmaadawi, MD
Contact: Joni Rousculp | 574-647-1593 | jrousculp@beaconhealthsystem.org
Protocol I4V-MC-JAJD A Randomized, Controlled Pragmatic Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis
Primary Physician investigator: Mary Ann Domingo
Contact: Julianne Havens | 574-647-3125 | jhavens@beaconhealthsystem.org
A prospective, multi-center, single arm PMCF study to evaluate the safety and performance of ENTACT™ (Next Generation) resorbable septal staple system for septoplasty.
Primary Physician: John Gilbert, DO
Contact: Vanessa De Pue | 574-647-6584 | vdepue@beaconhealthsystem.org
A Double-blind, Randomized, Psychoactive Placebo-controlled, Study to Evaluate the Efficacy and Safety of 3 Fixed Doses (28 mg, 56 mg and 84 mg) of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Pediatric Subjects Assessed to be at Imminent Risk for Suicide.
Primary Physician: Ahmed Elmaadawi, MD
Contact: Julianne Havens | 574-647-3125 | jhavens@beaconhealthsystem.org
A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No- Stimulation Control in Subjects With Treatment-Resistant Depression.
Primary Physician: Ahmed Elmaadawi, MD
Contact: Vanessa De Pue | 574-647-6584 | vdepue@beaconhealthsystem.org