Participation FAQ's

 

What is a Clinical Trial?

Is a Clinical Trial safe?

Am I the first to test these new drugs?

Does a clinical trial cost me anything?

Am I allowed to stop participating after I start?

What happens during my first visit?

Will I go through any medical tests?

How long will the study last?

What happens after my first visit?

When will I receive the study medication?

Will I experience any side effects?

Is my information shared with anyone?

What happens at the end of the study?

How is the information in the study used?

 

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What is a Clinical Trial?

Every day, scientists in pharmaceutical companies work on developing new medications and treatments. Clinical trials are studies in which scientists and doctors test new medications and treatments to see if they will improve health. A clinical trial is a carefully designed study that involves people like you who volunteer to receive these medications and treatments under close supervision by a physician.


Is a Clinical Trial safe?

All clinical trials are closely overseen by the U.S. government. An Institutional Review Board (IRB) is an independent committee whose job is to make sure your legal and ethical rights are fully protected and that you are not exposed to any unnecessary risks.

 

Am I the first to test these new drugs?

Before a new drug is found to be safe and effective enough to be tested in humans, it must go through extensive pre-testing. This testing involves years of experiments in computer models, animals and human cells. Most of the drugs we test at KRK have already been through multiple clinical trials with human subjects.

 

Does a clinical trial cost me anything?

No. All parts of the trial such as medical procedures, medications, examinations and laboratory tests are at no cost to you. You may also receive compensation for your time, travel and expenses.

 

Am I allowed to stop participating after I start?

You can stop the trial at any time. Just speak with the physician or coordinator about your reasons for withdrawing.

 

The Clinical Trial Process

 

What happens during my first visit?

During the first visit you will meet the study coordinator and physician. They will explain study procedures, study length, potential risks and benefits, alternative treatments and key study contacts. Any questions you have will be answered before you agree to begin the study.

 

Will I go through any medical tests?

Depending on the study you volunteer for, you may go through various medical tests. This might include an EKG, blood work, vital signs, and urinalysis. A physical examination and medical history will be done. You will continue to receive close medical attention throughout the study.

 

How long will the study last?

Every study is different. A study may last anywhere from one visit to one or more years. The number and frequency of visits will be explained during your first visit.

 

What happens after my first visit?

At each visit you will meet with the physician and/or coordinator. They will carefully check your progress and closely follow your physical and medical well-being. You may be required to retake some of the medical tests you took in the first visit.

 

When will I receive the study medication?

This depends on the study. You may receive the first dose of study medication at the first or second visit. You may be required to stop certain medications that are similar to the study medication before receiving your first dose.

 

Will I experience any side effects?

You may or may not. Side effects are common in many medications. The information gained from a clinical trial not only shows whether the study medication is effective or not, but also shows whether there are side effects. Please be certain to tell the study physician of any possible side-effects you may be experiencing.

 

Is my information shared with anyone?

All your health and personal information is kept confidential at all times. Under federal law, any information obtained in a research study cannot be disclosed without your consent. Even the pharmaceutical company that sponsors the research study will not know your name.

 

What happens at the end of the study?

At the end of the study you will stop the study medication. The study physician and coordinator will again assess your progress and conduct a medical examination. The study physician can make recommendations for follow-up treatment. Some studies may offer you an opportunity to enter another phase of the study and to continue on the study medication for a longer period of time. You may also be eligible to enter other new or ongoing studies.

 

How is the information in the study used?

A clinical trial of a medication can include hundreds and thousands of people throughout the U.S.A. and even around the world. When the study is completed, all the data is collected and analyzed. Scientists, physicians and the government will review the data. At this time, the medication may be approved for use on the market or be approved to progress on to larger trials.