What are Clinical Trials?
Clinical trials are a type of research that studies new tests and treatments and evaluates their effects on human health outcomes. Clinical Trials include medical interventions including drugs, cells and other biological products, surgical procedures, radiological procedures, devices, behavioral treatments, and preventive care.
The many advances make in treatments over the past three decades began a s research and clinical trials. As a research volunteer, you play a pivotal role in the pursuit of new and more successful treatments.
Clinical trials are carefully designed, reviewed, and completed, and need to be approved before they can start. People of all ages can take part in clinical trials, including children.
Why Participate in a Clinical Trial?
You may choose to participate in clinical trials for a variety of reasons. Volunteering for research studies can provide access to promising new drugs before the are available to the public. While there is always a chance that a new treatment will prove to be less effective than hoped, there is also reason to believe that it will be as good or better than current treatments. Every effort is made to ensure you safety, the care from the research team and physicians during the study is highly controlled and monitored.
Questions to Ask Before Participating
If you are thinking about taking part in a clinical trial, there are some important questions you should ask:
- What is the purpose of the study?
- What does the study involve?
- What kinds of tests and treatments?
- What is likely to happen in my case with my participation in this study?
- Are there standard treatments for my case?
- If the study is chosen, how do they compare to standard treatment?
- What other choices do I have? Advantages and disadvantages?
- How could the study affect my daily life?
- What side effects cold I expect from the study?
- How long will the study last? Will it require an extra time commitment on my part?
- Will I have to be hospitalized? If so, for how long?
- Will I have any expenses? Will any part of the treatment be free?
- If I were harmed because of the research, what treatment would I be entitled to?
- What type of long-term follow-up care is part of the study?
Our team consists of physicians, nurses, and regulatory specialists facilitating the day to day operations of the clinical trials by ensuring the following:
- Monitoring a participant on clinical trials
- Regulatory documents comply with federal guideline
- Data is accurate and timely submitted
- Care is given according to the clinical trial guideline
If you have questions about clinical trial you can contact us at [email protected] or by phone at 616.252.5020
Current Clinical Trials
Phase II, Double-blind, Placebo-controlled, Efficacy, and Safety Study of APX-115 in Hospitalized Patients with Confirmed Mild to Moderate COVID-19
Condition: Individuals with confirms COVID with mild to moderate symptoms that have been admitted to the hospital
Purpose: To determine and understand how APX-115 is tolerated and its effect on clinical recovery from COVID
Investigators: Jeffrey Fletcher, MD ; Del DeHart, MD
University of Michigan Health – West is a member of the Cancer Research Consortium of West Michigan (CRCWM). Eleven hospitals and health care systems, including University of Michigan Health – West, are part of this consortium. This consortium brings the highest level of clinical trials from the National Cancer Institute (NCI) to men, women, and children of our communities. NCI Community Oncology Research Program (NCORP) Grant, which is supporting CRCWM.
More information about CRCWM, along with a listing of available clinical trials at www.crcwm.org or contact the University of Michigan Health – West Cancer Center at 616-252-8100 and ask to speak to a Clinical Research Registered Nurse.
SATURN: Statins Use in Intracerebral Hemorrhage Patients
Condition: Intracerebral hemorrhage on statin therapy
Purpose: To determine whether continuation vs. discontinuation of statin drugs is the best strategy after a lobar intracerebral hemorrhage (ICH).
Investigators: Augusto Elias, MD; Jeffrey Fletcher, MD
Clinical Study of Neuspera’ s Implantable sacral Nerve Stimulation System in Patients with Symptoms of Urinary Urgency Incontinence
Condition: Urinary Urgency Incontinence
Purpose: To assess the effectiveness of the nerve stimulation regarding the improvement of the symptoms of urinary urgency incontinence in short term and long-term status
Investigator: Jannah Thompson, MD
CanGaroo Registry Study
Multi-Center Registry Evaluation Participants Who Receive CanGaroo Envelope or No Envelope During CIED Implantation
Condition: Individuals who will be receiving a Cardiac Implantable Electronic Device (CIED)—known as a pacemaker
Purpose: To determine and understand how different individuals with the surgery done in slightly different ways might have different results
Investigators: Rony Gorges, MD; Michael Sumners, DO
Randomized, Double-blind, Placebo-controlled, Multicenter Trial, Assessing the Impact of Inclisiran on Major Adverse Cardiovascular Events in Participants with Established Cardiovascular Disease
Condition: Individuals who have established cardiovascular events, such as Myocardial Infarction, Stroke or Symptomatic Peripheral Arterial Disease
Purpose: To determine if Inclisiran is effective in reducing any addition cardiovascular events in individuals who have a history of cardiovascular disease
Investigators: Rony Gorges, MD, Gunjan Gholkar, MD; Michael Sumners, DO. Barbara Karenko, DO
A Longitudinal Prospective Observational Study of the Characteristics, Treatment Patterns and Health Outcomes of Individuals with Severe Asthma in the United States
Condition: Severe Asthma
Purpose: To collect information on patient characteristics, treatment patterns, and health outcomes in patients with severe asthma.
Investigator: Gregory Neagos, MD
remede System Therapy Registry (reST Registry) ON HOLD
Condition: Central Sleep Apnea
The purpose of this registry is to collect safety and effectiveness data in participants with central sleep apnea implanted with the remede System.
Investigator: Matthew Sevensma, DO
Condition: Amyotrophic Lateral Sclerosis (ALS), progressive neurodegenerative disease progression
Purpose: Recruit individuals in and surrounding Michigan into the University of Michigan ALS Patient Repository
Investigators: Stephen Goutman, MD
MIHAS: Music Intervention in Hyperacute Stroke patients—ON HOLD
Condition: Individuals who have been diagnosed with having an acute stroke
Purpose: To evaluate the use of music therapy for patients who have just had a stroke to see if there is a reduction in blood pressure, anxiety, pain, and confusion.
Investigators: Jeffrey Fletcher, MD
Randomized, Double-blind, Placebo-controlled, Multicenter, Phase III Study Evaluation Long-term Efficacy and Safety of Lanifibranor in Adult Patients with Non-cirrhotic Non-alcoholic Steatohepatitis and Fibrosis 2 / Fibrosis 3 Stage of Liver Fibrosis
Condition: Individuals who have fibrosis of the liver, which is not related to alcoholic, sometimes called “Fatty Liver”
Purpose: To determine and assess the effect of Lanifibranor in the resolution / improvement and / or delaying the progression of liver fibrosis
Investigators: Ammar Hassan, MD