• What is a clinical trial?

The purpose of a clinical trial is to collect information about the safety and efficacy of a medication when used in a human. The U.S. Food and Drug Administration (FDA) requires that very rigorous detail be applied to conducting the trial and collecting the information. Once the FDA reviews and approves all the collected information on the medication from the trial, they will then make a decision as to whether to approve the medication so that it can begin being used by physicians.

• How long does a clinical trial last?

Clinical trials last varying lengths of time ranging from a few months to a few years. It depends on the specific clinical trial.

• Why should I participate?

1. Access

2. Monitoring

3. Empowerment

4. Compassion
When current treatment is not working and alternative medications are not available, a patient may have access to medications otherwise unavailable

By participating, you will help others by contributing to the advancement of medical care.

When you participate, you will experience close monitoring of your condition and medications
Through participation you will take a more active role in the control of you disease state.

• What are the risks involved?

As with any clinical trial involving a new medication or a new use of an existing medication, there are risks of adverse reactions, side effects and drug interactions. The purpose of a trial is to explore safety issues. However, most clinical trials have at least some degree of initial research previously performed on humans.

• What happens if I don’t qualify for the trial?

First and foremost, we will contact your physician to advise him or her so that usual care can be provided. If you do fail to qualify for a trial, you will have the option to attempt to qualify for any additional existing trial or one in the future. We just require you participate in 1 trial at a time.

• Do I have to pay anything to be in the trial?

No. Study visits, exams, labs and study related medications are provided free for the patient. The patient, in most cases, will be compensated for the study visit.

• Will my current doctor be made aware?

Yes. We will be in contact with your personal physician very closely to make him/her aware of your participation in the trial and any key issues during the process of the trial and study visits.




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