About Clinical Trials

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What is a clinical trial?

A clinical trial is a scientific study to see if a new medicine or treatment works in people. Clinical trials allow doctors to find new and better ways to prevent, detect, diagnose, control, and treat illnesses.

All new medications are tested for safety and effectiveness through clinical trials. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people.

Please call 937-424-1050 to set up a screening appointment or complete our online form.

Am I protected as a volunteer patient?

Yes. The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is federally regulated with built in safeguards to protect the participants.

The trial follows a carefully controlled protocol, a study plan which details what researchers will do in the study. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies. Individual participants' names will remain secret and will not be mentioned in these reports.

Every clinical trial in the U.S. must be approved and monitored by an Ethical Review Board to insure the safety of study volunteers. The ethics board is an independent committee of physicians, statisticians, community advocates, and others that ensures that a clinical trial is ethical and the rights of study participants are protected.

All clinical trials involving people must, by federal regulation, have an ethical review board to initially approve and periodically review the research.

What are the benefits and risks of participation in a clinical trial?

Benefits

Clinical trials that are well-designed and well-executed are the best treatment approach for eligible participants to:

    • Play an active role in their own health care.

    • Gain access to new research treatments before they are widely available.

    • Obtain expert medical care at leading health care facilities during the trial.

    • Help others by contributing to medical research.

Risks

There are risks to clinical trials:

    • In a placebo-controlled study, the volunteer may receive a placebo throughout the duration of the trial.

    • There may be unpleasant side effects to treatment.

What is my role as a participant in a clinical trial?

As a study volunteer, you are screened by our staff to confirm your eligibility for the study, and then we schedule you for a screening visit at our office.

During your screening visit, the doctor meets with you to confirm your eligibility, to review the informed consent, and to answer questions that you have. If you qualify and consent to participate, the doctor will evaluate your condition.

You will receive a complete physical and psychiatric examination, including lab work and an ECG. There is no charge for your participation, study medications or office visits. As a patient, you will be responsible for attending all scheduled appointments.

We will compensate you for transportation as appropriate. Please call 937-424-1050 to set up a screening appointment or complete our online form and we will contact you.

What are the phases of clinical trials?

Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions.

Midwest Clinical Research conducts Phase II through Phase IV clinical trials.

In Phase I trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase II trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase III trials, the study drug or treatment is given to large groups 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 drug or treatment to be used safely.

Phase IV trials are conducted after a drug has been approved by the FDA. These studies help determine additional information including the drug's risks, benefits, and optimal use.