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?
Research Team
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
Contact Us:
If you have questions about clinical trial you can contact us at [email protected] or by phone at 616.252.5020.
Current Clinical Trials
Cancer
Phase 1B study of Ribociclib Administered Concurrently with Postoperative Radiation Therapy in Patients with High-Risk, Node Positive, HR+/HER2- Breast Cancer
Condition: Breast Cancer that is ER positive, HER-2 Negative with >/=4 lymph nodes positive OR 1-3 positive lymph nodes and have one of the following: T3 tumor, Grade 3 tumor of Ki-67 >/=20%. Has had total removal of the breast cancer.
Purpose: To determine the safety and tolerability of the Ribociclib and radiation therapy.
Investigators: All Medical Oncologists and Radiation Oncologists at University of Michigan Health-West Cancer Center.
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.
Neurology
ALS
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
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
CAPTIVIA
Comparison of Anti-coagulation and anti-Platelet Therapies for Intracranial Vascular Atherostenosis
Condition: Individuals who have had a stroke which is due to narrowing of an artery in the brain (intracranial atherosclerotic stenosis)
Purpose: To evaluate the use of 3 different medical management to prevent another stroke in the future
Investigators: Fazeel Siddiqui, MD
Neuroradiology
RESTORE
Real-World Analyses of Stroke-Thrombus Occlusion Retrieval
Condition: Individuals who have had a stroke due to a blood clot and has been removed by using the SOFIA aspiration catheter
Purpose: To collect data about stroke treatment to expand knowledge about th safety and effectiveness of the treatment.
Investigators: Fazeel Siddiqui, MD
Pulmonology
CHRONICLE
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
LIGHTHOUSE
Cancer Screening Collection Study
Condition: Individuals who are eligible to obtain a Low Dose CAT Scan for the screening for Lung Cancer for 3 years
Purpose: To collect blood samples and medical information to help develop and evaluate a blood test that can screen for many cancers from a single blood draw. A validated blood-based assay can aid in achieving higher participation in screening and increasing coverage, leading to earlier detection of cancer when lesions are more amenable to treatments and thus reduce the burden of cancer mortality.
Investigators: Terrance Barnes, MD
Sleep
remede System Therapy Registry (reST Registry)
Condition: Central Sleep Apnea
Purpose: To collect safety and effectiveness data in participants with central sleep apnea implanted with the remede System.
Investigator: Matthew Sevensma, DO