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Getting Involved With Medical Research

People participate in clinical research trials for a variety of reasons. In various phases of clinical research trials, volunteers can gain access to promising medication long before these compounds are on the market. In addition to gaining access to medication, volunteers also receive treatment from licensed physicians and are often eligible for compensation to assist with travel expenses, as well as medical services during the course of the study. At MediSphere Medical Research we feel it is paramount to provide quality research without compromising the safety and rights of our volunteers. Patients' rights and safety are protected in two important ways:

Any research center awarded a research grant from a pharmaceutical company must obtain approval to conduct the study from an Institutional Review Board. The review board is responsible for examining the study to ensure that the volunteers' rights are protected, and the study does not present any undue or unnecessary risk to the patient.

Anyone volunteering to participate in a clinical trial in the United States is required to sign an "Informed Consent" form. The purpose of this form is to provide details about the study, the risks associated with the study medication, and what procedures the volunteer will undergo during the course of the study. Volunteers considering participation in clinical research should discuss it with their primary care physicians or medical caregivers. Volunteers should not hesitate to ask questions when participating in a clinical research trial.

Criteria that would allow volunteers to participate are based on factors such as age, gender, type of disease, previous treatment history, and other medical conditions. It is important to not take rejection of participating personally Instead the criteria are used to identify appropriate volunteers and keep them safe.

A volunteer's role is important to researchers in understanding specific health issues. During gathering of general medical information, it becomes the volunteer's responsibility to provide accurate information about their health, medication, and family's medical history. All information obtained is held confidential and is used to properly qualify patients for a study. Once a volunteer qualifies for the study of interest and is enrolled, full participation of the following will aid in successful study results.

A Protocol is a study plan on which all clinical trials are based. The plan is carefully designed to safeguard the health of the volunteers as well as answer specific research questions, it describes what types of volunteers are needed, the schedule of tests, procedures and medications, and dosages and length of study.

Clinical Study Phases

Each phase has a different purpose that helps scientists answer different questions.

MediSphere Performs Phases 2-4

Phase I Researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its Safety, determine the Dosage Range, and Identify Side Effects.

Phase II Researchers test the experimental drug or treatment on a larger group of people (100-300) so see if it is Effective and to further evaluate its Safety.

Phase III Researchers test the experimental drug or treatment to an even larger group of people (1,000-3,000) to confirm its Effectiveness, Monitor Side Effects, Compare it to commonly used treatments, and Collect information that will allow the experimental drug or treatment to be used Safely.

Phase IV Researchers conduct Clinical Trials to identify and evaluate the long-term effects of already approved new drugs and treatments over a lengthy period for a greater number of patients. Phase IV research takes place after the FDA approves the marketing of a new drug. Although the drug or treatment has previously been approved, studies are conducted to see if they can be used for other health indications. Through Phase IV Clinical Studies, new drugs can be tested continuously to uncover more information about efficacy, safety and side effects after being approved for marketing.