What is a Clinical Trial?
As a form of scientific research, clinical trials develop critical new approaches in treating and preventing various medical ailments. Participants volunteer in order to contribute to medical advancement efforts while receiving access to innovative treatments not yet available to the general population. Clinical trials gather the data necessary to approve, and potentially alter, treatments for widespread applications. Studies like these analyze the effects of the trials to guarantee safety and utmost utility for commonplace usage in the future. (phases)
Clinical trials conducted ar Mir Neurology & Spine Center provide developing treatment options for participating patients. The center specializes in trials including, but not limited to:
Phases of Clinical Trials
Mir Neurology & Spine Center specializes in Phase III and Phase IV trials.
Phase III Trials: These trials consist of participation from patients from differing national locations. This study tests a new treatment opportunity, a potential replacement to current options.
Phase IV Trials: These trials observe the long-term effects of a new treatment, following its approval for widespread use by the FDA.
Why Should I Participate in a Clinical Trial?
Clinical trials provide the opportunity for patients to recieve the most current treatments while supporting research endeavors that could potentially better the lives of several individuals. As with any treatment, a particular patient’s response to a treatment differs in effect and an exact result cannot be guaranteed. In clinical trials, the treatment offered may be equatable to–or possibly better than–current options, given specific conditions. The trials being conducted are implemented due to belief in its potential, or the treatment is simply being tested for widespread use. Clinical trials deliver the newest treatment opportunities to patients while moving the medical community fowards in bettering future treatments.
Are Clinical Trials Safe?
Clinical trials recieve approval from both an Institutional Review Board and the FDA, which guarantees that the trial holsters no unreasonable risk to patients. Trained healthcare professionals will closely oversee patients through the duration of the trials to ensure quality and safety. Above all, clinical trials are considered experimental, so although approved, results may not be satisfactory.
Each clinical trial maintains differing requirements for participation. You may be recommended for a clinical trial by a physician, however, it is a private decision that should be made after receiving and considering all available information. The team at Mir Neurology & Spine Center will discuss your eligibility and whether clinical trials are the most suitable option for you.
How Can I Participate in a Clinical Trial?
Clinical trial participation is voluntary, with the final decision determined by the patient in question. A recommendation may be given to you by your physician based upon personal medical details, however, you can also ask your physician whether or not your participation would be safe and recommended. The Mir Neurology & Spine Center team will determine final eligibility, potentially by requesting additional testing.
When considering to participate in a clinical trial, an understanding of Informed Consent is crucial. Informed Consent lists the expansive details of the study, including potential risks. A comprehensive understanding of both the benefits and the risks must be ensured in order to fully consent to the study. The team at Mir Neurology will assist as necessary to deliver explanations and answer any questions to guarantee a well-informed decision.
Mir Neurology & Spine Center will facilitate your participation throughout the duration of the trial by scheduling appointments and disclosing progress and new information. Through these visits, the team at Mir Neurology will observe your progression and ensure proper protocol.
Current Studies at Mir Neurology & Spine Center
|Esteem||Multiple Sclerosis||The Esteem Trial is from the pharmaceutical company Biogen. The drug Tecfidera is produced for patients diagnosed with multiple sclerosis (MS). We currently have 21 patients enrolled in this trial which is a Phase 4. Tecfidera is meant to cut relapses in half, delay the progression of physical disability and slow development of brain lesions. The primary objective of the study is to determine the incidence, type, and pattern of serious adverse events, including but not limited to serious infections, hepatic events, malignancies, renal events and of adverse events leading to treatment discontinuation in patients with MS.|
|Passage||Multiple Sclerosis||The Passage Trial is from the pharmaceutical company Novartis. The drug Gilenya is produced for patients diagnosed with multiple sclerosis (MS). We currently have 3 patients enrolled in this Phase 4 trial. Gilenya reduces relapse by more than half, reduces the risk of disability progression, and results in fewer lesions as seen on MRI’S. The most common side effect is experiencing a slower heart rate and will usually return to normal within the first month.|
|Avanir||Alzheimer’s Disease||The Avanir Trial is new to the practice and will be a Phase 3 trial. It is meant to decrease the agitation in patients diagnosed with Alzheimer’s Disease (AD). We have not yet been approved to start prescribing the drug. The goal of Avanir is to alleviate clinical change, quality of life and caregiver burden as well as maintain or improve quality of life.|
|Lundbeck||Parkinson’s Disease||The Lundbeck Trial is also a new drug treatment. Lundbeck is aimed at helping patients diagnosed with Parkinson’s disease. At the present time, there is no cure for Parkinson’s, but treatment for symptoms are available and research continues. Although current Parkinson’s treatments cannot stop the progression of the disease, they can temporarily control and relieve symptoms and improve quality of life.|
Who Will Be Conducting These Trials?
|Dr. Sarim Mir, MD||Principal Investigatorfirstname.lastname@example.org|
|Mohammad Imran, MD||Assistant Clinical Research Directoremail@example.com|
|Jean Thomas, RN||Clinical Research Associatefirstname.lastname@example.org|
You may contact us regarding clinical trials by calling 301-797-7600 or emailing email@example.com. For more information, you may visit the official site for clinical trials, at clinicaltrials.gov.
Hagerstown: 11110 Medical Campus Road, Suite 151, Hagerstown, MD 21742
Cumberland: 924 Seton Drive, Suite C, Cumberland, MD 21502