What is a clinical trial and why should I participate in one?

Clinical trials are programs designed to determine if new treatments are safe and effective in curing or relieving symptoms of a particular illness or condition. Often these treatments are new medications.

Your participation in a clinical trial will contribute to the discovery of treatments that may one day alleviate or even cure an illness. At the same time, you may gain access to new research medications before they are on the market.

What are the advantages and disadvantages of participating in a clinical trial?

Potential risks and benefits are different from study to study, and will be fully explained to you before you decide to participate in the study. Just as you may experience benefits and/or side effects with any medication currently on the market, the same applies for experimental drugs. Your involvement in a study is entirely voluntary and you may withdraw at any point.


Participating in a clinical trial may allow you to: 

-Obtain access to new research medications before they are on the market.

-Make a significant contribution to the research of a new medication in order to help others.

-Acquire professional medical care at not cost without cost or need for health insurance.


As with taking any medication:

-there is a possibility of experiencing unpleasant side effects due to the research medication.

-you may not obtain a benefit from the research treatment.

As a participant in a clinical trial you:

-may receive placebo. However, many clinical trials which compare a new medication to placebo also offer long-term (6 months to one year, typically) open-label studies where you will receive the active study medication at a known dosage without cost to you.

-may not have access to the study medication after you complete the trial.

What is the cost of participating in a clinical trial?

None. You will receive free personal medical care from our clinical team as well as study medication and medical evaluation.

Is there any kind of compensation for my participation.

Yes. You will compensated for your travel and time spent at the office. This compensation varies per trial.

Is my participation confidential?

Yes. The  HIPAA (Health Insurance Portability and Accountability Act) policy which applies to general medical practices is also applied to clinical trials. The FDA as well as  Independent Review Boards oversee all clinical trials to protect the safety, well-being, and confidentiality of all participants.

What can I expect during the visits?

You will meet with a board certified physician and a clinical staff member at every visit, to focus on your health and progress in the study. In some visits you will answer brief questionnaires and/or perform medical tests periodically (EKG, labs, blood pressure, etc) throughout the study to ensure your safety and well-being. The time for each visit is at least 30 minutes. Some appointments may be longer depending on the clinical trial.

What is a protocol?

A protocol is a study guide detailing all required procedures, criteria, and schedules conducted in the trial. All study staff are trained with each protocol to ensure proper execution.

What are the different phases in clinical research?

Phase I studies are designed to determine the most tolerable dosage of the study medication. During this phase, information about safety and potential side effects are collected.

Phase II studies are larger participant groups designed to determine if the study medication is effective and safe in treating a specific illness or condition.

Phase III studies most often compare the new study medication to existing, FDA-approved medications for a specific condition or illness. This population group usually is larger than the Phase II.

Phase IV studies are also known as Post-Marketing Surveillance studies. After a medication has received approval by the FDA to be marketed, statistics may be collected in these studies, which provides data on long-term safety, efficacy, and additional suggestive uses of this medication beyond the indication for which it has been approved.

What is a placebo?

A placebo is a pill containing no active ingredient. In clinical trials a placebo is used in comparison to the study medication to assess the effectiveness of the study medication.

Can I keep taking the medication even after the study ends?

Some clinical trials offer the opportunity to continue on the medication by participating in a long-term, (typically 6-12months) open-label study in which you would receive the active study medication at a known dosage, free of cost.  In general, however,  the study medication is provided for research purposes only and it is not accessible to the public until it is approved for a given illness by the FDA. Therefore, it would only be available during  the study. When your participation in a clinical trial ends, we will provide referrals that will best suit the continuation of your treatment.

Who do I contact if I have a question or concern?

Our clinical staff is available during regular office hours (Monday to Friday, 9am to 5pm). We will also provide you with a 24hr contact number for a study physician, in case you need immediate assistance.

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