What is a Clinical Trial?

What is a Clinical Trial?

 Who should participate in Clinical Trials?

• Choosing to participate in a clinical trial is an important personal decision. If you are interested in a particular research study you should know as much as possible about the clinical trial and feel comfortable asking the members of the healthcare team questions about it. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study during a process called "Informed Consent". This gives you the opportunity to make the decision that is right for you. All clinical trials have guidelines about who can participate. Study specific criteria are used to identify appropriate participants and keep them safe. Before joining a clinical trial, a participant must qualify for the study. A participant may withdraw from the trial at any time. 

Why do children participate in Clinical Trials? 

• Children are not small adults and their medication should be accurate according to their age and developmental level.  Clinical research allows physicians to closely monitor the child or adolescent's response to new medications, therapies, or treatment. 

What is the FDA?

• The FDA is known as the Food and Drug Administration.  The FDA verifies that new medications are safe and effective before they may be prescribed by a physician.  For more information about the FDA and Clinical Trials click here.

 What is the IRB?

• The IRB is known as the Institutional Review Board.  The IRB reviews research protocol plans and consent documents before patients may participate in a research project.  The IRB is a group of health care providers that include physicians, pharmacists, and community members who review the projects for safety and ethical concerns. They verify that the researchers have provided information the patient may  need to know in the consent document and that the research physicians and team conduct the research as noted in the project protocol and completes all items according to FDA requirements.  They are concerned about patient safety. 

• University of Oklahoma Health Sciences Center IRB

• Office of Human Research Protection
  

What is a Consent Form?

• A Consent Form is a document that notes the purpose of the study, who may participate, what procedures will be performed, possible adverse events to the therapy being given, costs, and benefits of the study.

• Signing a Consent Form means that you have received information about the project in writing.

• You should never feel obligated to sign a Consent Form.  You should be given enough time to read, digest, and ask questions.  You may wish to take the form home with you and discuss with family members, friends, and healthcare providers.

What is an Assent Form?

• An Assent form is a form for the child to read and discuss with their parents regarding their choice to participate in a study

What is Placebo?

• A Placebo is an inactive ingredient that looks like the medication that you may receive.  Sometimes a placebo is called a sugar pill, although there is no sugar in the pill.  You should ask the study doctor if this is being used in the study and if so when and how

What is a Double-Blind Study?

• A Double-Blind study is a study that involves placebo (inactive ingredient that looks like the study medicine) and the study medicine.  A percentage of the patients will receive placebo and a percentage will receive the actual study medicine.  The study physician and his/her research team will not know if the child is receiving the actual medicine or placebo.

What Questions Should we ask the Research Doctor and Nurse?

• What is the purpose of the study?

• What are the potential benefits?

• Are there risks or side effects?

• How long will I be in the study?

• How often will I need to visit the clinic?

• What tests will I need?

• Is there a chance I will receive a placebo?

• Have other people been treated with this drug before in clinical studies?

• What medications, treatments and procedures should I avoid while in the study?

• Will I continue to see my personal doctor?

• What are my treatment options if I don't participate in the study?

• Will there be any costs to me?

• Will I learn of the study results?  If so, when?

• How many volunteers will participate in the study?

• Will my medical records remain confidential?

• Who is sponsoring the study?

• When the trial ends, can I continue to receive follow-up care and who will provide it?

• Can I continue to receive follow-up care and who will provide it?  

What items should I consider? 

• Is the study being conducted close to my home?  If not, will I be able to travel on a regular basis to the clinic?

• Am I willing to keep records of how my child feels?

• Am I willing to make a commitment to the project and keep it?

  LINKs

• OU Medicine Frequently Asked Questions regarding Clinical Trials.