What is a Clinical Trial?

Dr. Whitfield owner of Signature Gyn Services has been routinely involved in women’s health clinical research studies for over 10 years. As an OB/Gyn with over 30 years’ experience in women’s health, he understands how innovation in medical care and treatment can support evolution of medicine. You may wonder what all is involved in participating in a clinical trial and why you would want to participate. Here are several key points that may help you better understand clinical research and how you can benefit from participating in a clinical trial. 

What is a clinical trial?

Clinical trials are research studies that evaluate medical treatments to prove them safe and effective for general use. There are new medications, devices and services developed regularly. But it is a long process for a pharmaceutical or device manufacturer to gain FDA approval to make their product available to the general public. The clinical trial will help determine if the new treatment is better than, equal to, or no better than treatment that is already available.

What are the phases of a trial?

Phase I– After testing in animals, the medication is tested in healthy volunteers to further evaluate how the body processes it and to look for side effects.

Phase II– Medications given to the diseased patients are examined for reactions, side effects, and dosage(s) needed for treatment.

Phase III– The medication is evaluated in volunteers with the disease to gain further knowledge about its effectiveness in treating the disease.

Phase IV– Trials are continued for impacts to the body, & effectiveness at treating existing/new diseases. Typically done after treatment is approved by FDA for general use.

Where do the patients come from?

Many have the perception that a pharmaceutical company wanting to do a trail has a “cattle call” with a large group of patients coming to the office and forming a line going in one end of the building and out the other. The reality is that these companies contract with dozens of offices and clinics across the country who enroll patients from their local communities. And since many of these studies are also conducted simultaneously in other countries, the result is not just a diverse patient population across the country, but across the world.  

Who approves a clinical trial?

Before beginning a clinical trial on human subjects, it must be reviewed by and approved by the FDA and an Institutional Review Board (IRB). The FDA reviews the known information about the drug and the proposed plan for the clinical trial. An IRB is an ethics committee that reviews the trial making sure that the patient’s rights and safety are protected and that the trial is scientifically sound. The trial itself is conducted by qualified doctors and other healthcare professionals.

Can I participate?

If you meet certain criteria, you may qualify to volunteer for a clinical trial. This evaluation usually includes a review of your history and medical records, a physical exam, and blood work. It may also include additional studies such as a sonogram, x-ray, and EKG. All of these will be done at no cost to you, and you will be compensated for your time and travel.

What can I expect? 

Depending on the medication or device being evaluated, different trials will last different periods of time. For example, a trial may only require one visit. Others may last several months to a few years and require regular visits such as on a monthly or quarterly basis.

Is patient information confidential?

Yes. Confidentiality is maintained throughout the clinical trial including adhering to all HIPAA standards. All study-related information is kept separate from your regular medical records. Your insurance company will not be sent any information and will not receive any bills for study-related care. If you desire, your personal medical doctor can be informed of your participation. When results are sent to the FDA or if they are published in a medical journal, your identity will be kept confidential.

What are the advantages and disadvantages of participating?

Advantages of participating in a clinical trial include being able to receive new and innovative medications not currently available to the general public. You will also have an opportunity to learn more about your medical condition and available options. Assuming an active role in your healthcare may improve your quality of life. You can receive a complete medical exam, blood work, and possible additional studies such as a Pap smear, EKG, sonogram, or mammogram all provided at no cost to you. You will be monetarily compensated for your time and travel.

How much does it cost to participate? Do I need insurance?

There is no cost for you to participate and you do not need medical insurance to participate. You will be compensated for your time and travel. Your personal doctor does not need to approve your participation, but we will notify him/her of your participation if you desire. Your insurance company will not be notified of your participation, and they will not be sent any bills for any study-related activities. A clinical trial is an opportunity to participate in the future of medicine. Information gained may very well benefit you or a loved one as well as society in the future. Many patients feel a great satisfaction in “participating in the process” and “helping the next person”.

What if I don’t want to continue the trial? Am I locked in?

Participating in a clinical trial is completely voluntary. Sometimes people withdraw from a trial for reasons such as moving out of the area, other obligations to their family or job preventing them from keeping their appointments, or the medication is not working. Sometimes, the doctor may remove a patient from the trial due to changes in their health condition. You are free to withdraw from a trial at any time for any reason with no penalty to you.

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