Improving patient care is the goal of Beacon Medical Group Clinical Research. As one of the area\u2019s most comprehensive research centers, Beacon Clinical Research is involved in studies that are developing medications and devices for a variety of health conditions.<\/p>\n
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.<\/p>\n
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.<\/p>\n
For more information or to apply for a clinical trial contact Pamela Sims at 574.647.7883 or email psims@beaconhealthsystem.org<\/a>.<\/p>\n You can view our current clinical trials below.<\/strong><\/p>\n 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\u2019s resource for pharmaceutical and device research trials.\u00a0To learn more about clinical trials, please visit ClinicalTrials.gov<\/a>.<\/p>\n Volunteers are required to meet study criteria designed by the drug maker. The criteria make measurements of outcomes\u00a0\u2014 good, bad or indifferent\u00a0\u2014 possible.<\/p>\n 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.<\/p>\n 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.<\/p>\n 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.<\/p>\n \u201cResearch\u00a0is important to find out which treatments will be better for patients.\u00a0Research 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.\u00a0Research\u00a0can find answers\u00a0to things that are unknown, filling gaps in knowledge and changing the way that healthcare professionals work. Some of the common aims for conducting\u00a0research\u00a0studies are to.\u201d<\/p>\n \u201cAt Beacon Health, research trials are an everyday part of patients\u2019 care.\u00a0 Patients being cared for benefit from past\u00a0research, and continue to benefit from\u00a0research\u00a0that is currently being carried out. Ultimately, high-quality clinical\u00a0research\u00a0helps health care professionals to improve future healthcare.\u201d<\/p>\n \u201cOur research team are constantly raising awareness of the importance of clinical research to improve our patients\u2019 quality of life of life.\u201d –Dr. Ahmed Elmaadawi<\/p><\/blockquote>\n We support a network of research sites to assure consistent quality, safety and compliance for the clinical trial process.<\/p>\n Primary Physician Investigator: John Kobayashi, MD<\/p>\n Contact: Joni Rousculp | 574-647-1593 | <\/strong>jrousculp@beaconhealthsystem.org<\/a><\/p>\n Primary Physician Investigator: John Kobayashi, MD<\/p>\n Contact: Julianne Havens | 574-647-3125 | jhavens@beaconhealthsystem.org<\/a><\/p>\n Primary Physician Investigator: Joseph Schnittker, MD<\/p>\n Contact: Vanessa De Pue | 574-647-6584 |\u00a0 vdepue@beaconhealthsystem.org<\/a><\/p>\n Primary Physician Investigator: Ahmed Elmaadawi, MD<\/p>\n Contact: Joni Rousculp | 574-647-1593 | <\/strong>jrousculp@beaconhealthsystem.org<\/a><\/p>\n Primary Physician investigator: Mary Ann Domingo<\/p>\n Contact: Julianne Havens | 574-647-3125 | jhavens@beaconhealthsystem.org<\/a><\/p>\n A prospective, multi-center, single arm PMCF study to evaluate the safety and performance of ENTACT\u2122 (Next Generation) resorbable septal staple system for septoplasty.<\/strong><\/p>\n Primary Physician: John Gilbert, DO<\/p>\n Contact: Vanessa De Pue | 574-647-6584 |\u00a0 vdepue@beaconhealthsystem.org<\/a><\/p>\n 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.<\/strong><\/p>\n Primary Physician: Ahmed Elmaadawi, MD<\/p>\n Contact: Julianne Havens | 574-647-3125 | jhavens@beaconhealthsystem.org<\/a><\/p>\n A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy\u00ae System as Adjunctive Therapy Versus a No- Stimulation Control in Subjects With Treatment-Resistant Depression.<\/strong><\/p>\n Primary Physician: Ahmed Elmaadawi, MD<\/p>\nFor Patients<\/h2>\n
What is a clinical trial?<\/h3>\n
Who is eligible to participate in a clinical trial?<\/h3>\n
Our Research Experience<\/h2>\n
Areas of Clinical Research Expertise<\/h3>\n
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Current Clinical Trials<\/h2>\n
Heart Failure<\/strong> Optimization Study (HF-OPT)<\/a><\/h4>\n
\nA Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Injectafer\u00ae (Ferric Carboxymaltose) as Treatment for Heart Failure with Iron Deficiency<\/strong><\/a><\/h4>\n
\nVigilant ObservatIon of Gliadel Wafer Implant Registry (VIGILANT)<\/a><\/h4>\n
\nLong-term Antipsychotic Pediatric Safety Trial (LAPS)<\/h4>\n
\nProtocol I4V-MC-JAJD A Randomized, Controlled Pragmatic Phase 3b\/4 Study of Baricitinib in Patients with Rheumatoid Arthritis<\/h4>\n
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