What is a Clinical Trial? Five Questions to Ask Before Joining One

Clinical trials have transformed your life — even though you may not be aware of it.

Even if you have only taken over-the-counter medications, you have benefited from extensive research studies and clinical trials. These trials and scientific studies are vital to creating important medicines, medical devices and vaccinations to patients across the country and around the world.

What is a clinical trial?

A clinical trial is a research study that evaluates and tests new medications, therapies and procedures on patients to measure effectiveness. These trials also tell researchers about any side effects that may occur. There are extensive guidelines researchers must meet before a clinical trial can be conducted. Trials must be performed according to these very strict protocols to ensure patient safety and privacy. These protocols include:

• Details about medications and dosages
• Extensive information about who is eligible to participate in the trial
• Details about any tests or procedures
• Information concerning the length of the study
• Details about what information will be gathered

Most importantly, researchers carefully monitor patients’ health throughout the entire clinical trial process.  Review boards ensure that any trial poses minimal risks to patients. In addition, these boards also guard the rights of the participants and monitor the process to ensure there are no ethical violations.

Clinical trials are completed in phases. Each phase involves a certain number of participants. The first phase starts with a small group, and if results appear to be promising, it expands to a larger group.

After the trial, researchers will examine the results to determine if this is an effective treatment. If the results are promising, work will continue to bring the new medication to market or implement the new treatment technique.

Five questions you should ask your doctor before participating in a clinical trial:

Perhaps someone you know has mentioned participating in a clinical trial, and you may have wondered if it is the right choice for you. Before you decide to participate, it’s vital that you speak with your physician and ask these five questions.

1. HOW CAN THE CLINICAL TRIAL HELP ME?

Your physician will review the purpose of the trial, as well as any details regarding how the results can assist patients with similar issues. He or she will also mention any benefits you may receive from the trial.

2. HOW CAN I INVOLVE MY FAMILY DOCTOR?

Your physicians—particularly those who may be treating you for a chronic disease—should be kept in the loop during a clinical trial. Speak with the principal investigator leading the trial and be sure to provide contact information for your primary care or internal medicine physicians.

3. WHAT ARE THE RISKS AND BENEFITS OF THE TRIAL?

While every step is made to ensure that trials are safe and effective, sometimes medications can cause unwanted side effects.

4. WILL THE STUDY COST ME ANYTHING?

Most often, the studies do not cost anything and participants may actually be compensated. It is important to ask how much time will the study involve and where it is located. Some trials may not compensate participants for mileage.

5. WHAT IF I HAVE A MEDICAL PROBLEM WHILE I’M ENROLLED IN A STUDY?

Those conducting the clinical trial place patient safety at the top of their priority list. Your health will be carefully monitored; however, if you develop a medical problem, please notify those conducting the study.

Clinical trials are available locally through Raleigh Medical Group and Accellacare of Raleigh

We’ve partnered with Accellacare to help transform as many lives as possible. Accellacare has 12 clinical research locations throughout North Carolina, South Carolina, Illinois, and Tennessee. It is important to us that you feel confident about being a clinical trial participant. Please feel free to contact Accellacare to speak to a member of their team about clinical trial participation.

Do you have more questions about clinical trials? Please contact us. For your convenience, we’ve compiled some frequently asked questions about our clinical trials.