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Clinical Research FAQs:

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What is a clinical research study?

What are the different phases of clinical trial research?

What is a placebo?

What does “double-blind” mean?

Why would I want to be in a research study?

What are the potential risks of participating in a clinical research study?

What are the side effects?

What are the potential benefits of participating in a clinical research study?

How am I protected?

Can I continue my medication?

How long are the visits?

Will I be paid for participating?

What should I tell my doctors?

Does my participation in a clinical research study affect my medical insurance?

What if I change my mind and want to quit the study?

What happens after the study has completed? Will I see my results?

A clinical research study, or clinical trial, is a scientific study that tests the safety and health effects of potential new or investigational drugs, devices, or nutrition/food products. Research studies also test new uses or comparisons of known medications or food. Pharmaceutical and nutrition/food companies sponsor most studies.  All pharmaceutical studies must be approved by the Food & Drug Administration (FDA). Qualified doctors, nurses, and medical researchers conduct clinical studies.

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Phase I – evaluates the safety of the medication in a small number of healthy people, determines the appropriate dosage, and identifies side effects.

 

Phase II – focuses on whether the treatment works (efficacy). It involves a few hundred participants who have the relevant medical condition. Usually one group receives the experimental treatment, and another receives a placebo (in-active medication). In randomized studies, participants are assigned to each group by chance.

 

Phase III – emphasizes definitive statistical results. It involves giving the medication to several hundred to thousands of participants, and the response is compared with a commonly used treatment. If there is no effective existing treatment, the effects of the new treatment are compared with those of a placebo.

 

Phase IV – occurs after the medication has been approved by the Food and Drug Administration (FDA) and is available to the public. This post-marketing phase provides information about long-term effectiveness and side effects.

 

 

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A placebo is a tablet, capsule, or food product with no active ingredients made to look like the product being tested.

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Double-blind means that you and the doctor conducting the research study do not know who is receiving the study product and who is receiving placebo. This is done so that the doctor cannot influence your reaction to the study substance and to determine the safety and effectiveness of the study product.

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Participants in research studies are not “guinea pigs.” These medications, devices, or nutrition/food products have been tested for effectiveness and safety before they are ever used on human subjects.

 

Often, being in a research study provides very expensive study related lab tests, physical exams, electrocardiograms, dietary counseling, etc., free of charge. People who participate in these studies are taking an active role in their own health care and may even gain a better understanding of their own medical condition(s).

 

The health of millions has been improved because of advances in science and technology, and the willingness of thousands of individuals like you to take part in clinical research. The role of volunteer subjects as partners in clinical research is crucial in the quest for knowledge that will improve the health of future generations.

 

 

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There are generally known and unknown risks associated with clinical studies, such as:

 

• The treatment may not be effective for the participant.

• The protocol may require more of the participant’s time and attention than standard treatment (participants may need to visit the study site on a regular basis, be subjected to additional tests, and get more treatments than are normally necessary).

• There may be unpleasant and/or serious side effects resulting from the treatment.

 

 

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The possible side effects are listed for each study in the informed consent form. Most side effects listed are those common with many approved, marketed medications or nutrition/food products. After reading the informed consent, please discuss any questions you may have with the study coordinator or physician.

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Clinical study participants:

 

• Have access to potentially new treatments and help others by contributing to medical research.

• Have access to expert medical care (investigators are often specialists in the disease area being studied)

• Receive all tests (labs, mammograms, X-rays), physical exams, ECGs, and specialty consults (dietician, ophthalmologist, etc.) free of charge.

• Do not need insurance to participate and are paid for their time and travel.

 

 

During a clinical study, you are protected by the code of regulations of the FDA, good clinical practices, the informed consent (which outlines the goals, benefits, and risks of the study), and the institutional review board (IRB). The IRB is made up of doctors, pharmacists, clergy and law people.

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That depends. Usually you can continue medications for conditions not related to the study.

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Study visits can last from a few minutes to several hours. However, most visits take about 30-120 minutes and can be scheduled to meet your needs (very early in the morning through late in the afternoon).

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You will discuss payment for your participation with a member of our research team during the Informed Consent Process. The payment may be different for each study and it is provided to you for the time and effort it takes to participate in the study. If you decide to discontinue your study participation, you will be compensated for the portion of the study you completed.

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Please discuss any research study with your doctor.

 

We work in conjunction with your doctor or primary care provider. Your participation in a research study at MB Clinical Research is in addition to the care of your doctor. Only with your prior authorization, will we share with your doctor information or results about you and your participation.

 

 

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The study-related medical care and supplies you receive during a study are paid for by the sponsor of the clinical study; therefore your medical insurance will not be involved.

 

Your participation is confidential and insurance companies are not informed of your participation, unless there is an insurance claim directly related to your participation in a study. In this case, information about your health care may need to be released for the purpose of resolving your insurance claim.

 

 

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You can discontinue at any time. Participation in clinical research is voluntary.

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After analysis of all study data, the sponsor of the trial may submit the information to the FDA requesting approval to make the product available to the general public.

Your results may or may not be shared with you. This will be explained during the Informed Consent Process. In some studies you may see your results after all subjects have completed.

 

 

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