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Samantha: I’ve got to make a decision if I’m going to do this clinical trial or not, but…I’m kind of scared!
I don’t know anything about it – you always have all the answers, so that’s why I’m asking!

Jen: Well, Sam, honey…I… umm…I actually don’t know anything about clinical trials either!
That was something left out of the mom handbook.
But don’t worry! We’ll figure it out together. We can always look things up on the internet.

Gastro: Why look things up when you can be teleported up! We love medicine and educating!

Samantha: The MediKidz!

Pump: Sam, we heard you and your mom need some help understanding clinical trials.

Axon: And luckily for both of you, we’re doing a clinical trial ourselves!
Right this way to my super top-secret hidden lab!

Skindy: I don’t think most secret labs have a GIANT SIGN pointing to them.

Axon: I admit that I sometimes forget where I hide super-secret things, so I make super-big signs…it’s still cool!
Behold! This is where I make all my greatest inventions…and sometimes take naps.

Samantha: Whoa!

Jen: And your father thinks his workshop is cool!

Chi: Scientists and doctors are hard at work learning new ways to prevent, detect, and treat disease.
New treatments are tested in a lab before people are allowed to use them.

Samantha: That makes sense!

Gastro: Researchers run experiments to get to know as much about a new treatment as possible.
The most promising treatments are then tested in clinical trials in order to check if they are really effective and safe for patients.

Axon: Gastro, No! Don’t put that on!

Gastro: What? Why not? This helmet fits great!

Axon: It’s not a helmet – it’s a portable bio-waste receptacle.

Abacus: In other words…you’re wearing a toilet.

Skindy: Clinical trials might test new treatments – such as medicines and tools – or things you do, like exercise or a new diet.

Pump: People around the world participate in clinical trials to help scientists and doctors discover the best medicines.
Being part of a clinical trial is associated with some risks, since all the effects of a new medication may not be known yet.

Jen: So, can anyone do a clinical trial?

Axon: Who the doctors need for each clinical trial depends on what treatments they are testing - confirming the effectiveness of a new drug and how safe it is. Every clinical trial is carried out on a group of similar people that usually all have the same medical condition.

Axon: I’ve gathered all the supplies we’ll need. Let us head to MediLand and begin our clinical trial!

Samantha: MediLand? YES! I’ve always wanted to go to a planet that looks and works just like the human body!

Jen: I thought you wanted to go to Disney!

Gastro: Good! Let’s go!


Samantha: Whoa!

Jen: It’s very red in here…which is my favorite color!

Pump: Let’s move, team — lots to do.

Samantha: So, why would doctors need kids for clinical trials? Why not just use adults.

Pump: That’s because kids’ bodies work differently than adults’ bodies, and doctors need to make sure their treatments also work on kids, and without too many side effects.

Jen: Okay, so who are we doing a clinical trial on here? Kids? Teens? Adults?

Skindy: In MediLand, we’re able to do things a little differently.

Gastro: Yeah, when we want to see how a new medicine works on cells in the body...we test it directly ON the cells of the body!

Skindy: And today we’ll be testing a new treatment on the IMMUNE SYSTEM, your body’s natural defense against invaders like germs!

Samantha: Whoa!

Pump: Immune Cells, we’ve come to try a new treatment ray on you. One that is supposed to make you stronger.
Who here wants some more germ attacking power?

Immune Cells: Yeah! Woot! We do!

Chi: The doctors will tell you what to expect if you take part in a trial. You can then take some time to decide if you want to take part or not.

Axon: Talk about the trial with your parents or guardians. If you are still interested in taking part, you can let the doctors know that you give your permission to join the trial.

Immune Cell 1: Do you think I should do it?

Samantha: It is up to you. If you want a chance to be better at attacking germs, and if you understand the risks and what is expected from you, then I’d say yes!

Immune Cell 1: I do love attacking germs! I’m in!

Abacus: Your permission to volunteer in a trial is called assent.

Narrator: Remember! Be sure to ask the doctor if you have any questions.

Chi: For the trial to go ahead, your parents need to give their permission as well. Their permission is called informed consent.

Axon: Before a trial can start, your doctor may need to do some tests.

Pump: These are usually blood tests or imaging tests, like X-rays or scans.

Gastro: During a trial, your doctors will keep a close eye on you to make sure you’re doing well and to see how well your treatment is working. For your part, you must tell your parents and doctors whenever you don’t feel well.

Gastro: How are you doing? Do you need anything?

Immune Cell 1: Some personal space would be nice.

Skindy: From the start of the trial, you are part of the team. You may need to help the scientists and doctors by filling out questionnaires or keeping a diary every day.

Immune Cell 1: This is fun! No one ever asks me about myself, and I’m my favorite topic!

Pump: Okay, let’s see how well you normally work! Blast away!

Immune Cell 1: You got it!

Pump: Hmmm, good. But I think we can do better! Let's get this clinical trial started!

Abacus: Clinical trials involve four steps. These steps are called phases.
Each phase helps scientists and doctors learn something different about how the treatment works in people.

Samantha: You guys ready?

Chi: Phase 1 trials test a new treatment in people for the first time to see if it’s safe.
In this phase, we don’t know yet whether the treatment really works, or what side effects it might have.

Immune Cell 1: We’re adult soldiers! We can handle a little medicine.

Skindy: Phase 2 trials test how a new treatment works on a larger group of people who need it. People who have a disease, for example.

Axon: Phase 3 trials compare a new treatment against a control treatment to see which one is best.
Clinical trials with children usually begin at this stage.

Immune Cell 1: We’re newer, younger cells, and we’re ready to do our part!

Gastro: In phase 3 trials, you will be assigned at random to either receive the new treatment or the control treatment.
The control treatment may be a treatment that doctors already know works and is safe. Or, it may be a placebo.

Abacus: A placebo is an inactive substance that contains no medicine. It is used as a control to test how well new medicines work.

Axon: In some trials, you will not know which treatment you received until after the trial. This makes sure that the test is completely fair.

Immune Cell 1: I feel taller! And smarter! Quick, ask me a question!

Immune Cell 2: What’s the square root of 47,893?

Immune Cell 1: Umm, okay, I don’t feel that smart. How about how to spell cat?! I know I can do that.

Skindy: Phase 4 trials keep track of how safe and effective a new treatment is once it becomes available to everyone who needs it.

Pump: Time for us to see how effective this treatment was at making the immune cells stronger!
Ready. Steady. Go!!!

Immune Cell 2: Did I do that?

Pump: That looks pretty effective to me!

Samantha: Me too!

Pump: Not all trials are successful. Some trials are canceled if the new medication does not work well enough, or if there are too many side effects. Let’s head back to HQ!

Narrator: Back at MediKidz HQ.

Samantha: That was awesome! Clinical trials seem pretty cool!

Chi: They are, but you should remember that they can also be tough for the people taking part.

Axon: Indeed, having regular tests and seeing your doctors often can take up a lot of time. You may also develop an unexpected health problem.

Jen: So what happens if sam wants to stop taking the new treatment or wants to quit the trial?

Gastro: No problem! You can stop taking the treatment and remain in the trial. Or you can stop being in a trial whenever you want.
It is helpful if you stay in the trial until the end. But if you do want to stop, let the doctors and researchers know why.
The good news is that while you’re on a trial, you might get a new medicine before anyone else. However, you may also happen to have side effects with the new medicine.

Skindy: And remember, you’re contributing to medical research while on a trial, which means everything you do helps other people like you get better treatments!

Samantha: Wow, mom, we learned a lot today!

Jen: Let’s make sure we got it all.
A clinical trial is a test to see if a new treatment works and is safe to use.

Samantha: Diseases and medicines can affect children differently than adults, so the research team needs to know that the new treatment works well for children too.

Jen: To take part in a trial, we’ll need to know what will happen during the trial, including the inconveniences and possible risks.

Samantha: If I do decide to participate, My parents and I can then give permission for me to join the trial.
My doctors will keep a close eye on me during the trial and do tests to make sure I’m okay.

Jen: You can stop taking the medication or quit the trial at any time.

Samantha: But it’s great if I can get through to the end, because the research I’m taking part in helps so many people.

Pump: Perfect! You two nailed it!

Samantha: Thanks, MediKidz!

Jen: Yes, thank you all so much for helping Sam and me understand clinical trials!

Skindy: It’s what we do!

Axon: Teleporting you back home now!

Narrator: Later…

Physician: I just want you to know how much we appreciate your taking time to consider being part of the trial, Sam.

Samantha: I have thought about it…and yes, I would like to take part!

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