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Clinical Trial Story Time: A Friendly Intro for Your Child

If you’ve recently enrolled your child in a clinical trial, you may be wondering how to best prepare them for the experience. This blog aims to help you with that effort. The sections below are designed to be read directly to younger children. 

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What Is a Clinical Trial?

A clinical trial is when scientists, doctors, and people who are sick get together to find out how well a new medicine helps people feel better. 

Clinical trials … 

  1. Are the only way to make sure new medicines make people healthy and happy. 
  2. Find new ways to help people who didn’t have a way to feel better before start feeling better now 
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Why Should You Be Part of a Clinical Trial?

In the world of clinical trials, one of the most special things is called “research as care.” When kids like you have health challenges, clinical research can be a great way to get the very best care in the world that can’t be found anywhere else! The trial team helps you feel comfortable and cared for, and you help them find out more about how well the new medicine works. It’s teamwork that’s meant to help you — and lots of other kids around the world — feel better. 

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What Will Happen During the Clinical Trial?

At the start of the trial, the doctor’s team will talk to you all about what to expect. You will learn about how often you’ll visit them in person, some things you might get to do from home, and you’ll get to know some of the helpers who will be with you along the way. You’ll also learn about the different ways the study team will find out more about the medicine with your help! 

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Who Can Answer My Questions?

You can ask as many questions as you want during the clinical trial. You will have a friendly study buddy who you can always ask any questions you have. And don’t worry! You don’t have to think of all your questions when you meet your helper. Even if you think of a question later, you can ask any time. 

Final Note for Parents and Caregivers 

Do you or your child have additional questions or concerns about the clinical trial process? Visit our Resources page, talk to your doctor, and consider working with a patient advocate. 

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Redefining Clinical Trial Accessibility in the Age of DCTs
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Redefining Clinical Trial Accessibility in the Age of DCTs

You want to increase clinical research participation, but access issues keep getting in the way. How can people take part in clinical trials if they don’t know about them, can’t physically reach them, or don’t have the resources to participate remotely?   Uncover solutions to the research accessibility problem in the Clincial Trials For All discussion, “Redefining Clinical Trial Accessibility in the Age of DCTs.” Featuring Lightship patient advocacy and patient experience experts Samantha Eells, Sabina Kineen, Mel Mann, and Allison Rosen and hosted by Alec McChesney, director of business development at SCORR Marketing, this discussion is a must-watch for anyone interested in making research more equitable, diverse, and widespread.   Watch the recording now to explore:  

I’m About to Start a Clinical Trial. Now What?
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I’m About to Start a Clinical Trial. Now What?

So you’ve enrolled in a clinical trial. Congratulations! You’ve just taken an important step toward contributing to better health outcomes for people all over the world. And for many of you, this may also mean that you are receiving research as care for yourself. This is a big, exciting step and we’re here to help you know what to expect.  Understand Your Trial Phase There are clinical trials for each phase of pharmaceutical or medical device research. Here is a quick breakdown of what the different phases mean to help you understand more about the trial phase you are participating in.  Phase 0: These early exploratory clinical trials test less than 1% of the amount of the drug that will be used in later trial phases. This low-dose trial makes sure the medicine works as expected in the human body before conducting full-dose trials.  Phase I: Trials in this phase are all about safety. This type of trial often seeks healthy volunteers.  Phase II: Now we’re getting into treatment effectiveness trials. If you’re receiving research as a care option, you may be in a Phase II trial.  Phase III: Once a treatment is proved effective, longer-term trials that last several years and involve many more trial volunteers like you take place. This is another trial phase where you may be receiving research as a care option.  Post-market: Once new treatments are approved, ongoing studies may continue to observe the long-term effects of the drug.  Medical device trials: If you are volunteering for a medical device trial, the safety trial phase is called a pilot study, also known as a feasibility study. The effectiveness trial phase is called a pivotal trial. Then once the device is approved, post-market studies continue just as they do for pharmaceuticals.  Informed Consent As a clinical trial volunteer, a research representative will walk you through what is called the “informed consent” process. This is where study staff explain the possible risks and benefits of the trial and everything that is involved in your participation. You will have the opportunity to have any questions answered and confirm that you want to participate after receiving all the information. You can also choose to have a patient advocate support you through this process.  Trial Access The sponsor of your trial will discuss the logistics of trial access with you. Some trials require on-site, in-person visits to participate in the study, while others have some on-site visits and some check-ins that can be conducted from your home or from your existing medical practitioner’s office (called “hybrid trials”). In fact, some clinical trials can be conducted completely remotely with data collected from your home or doctor’s office (called “decentralized or virtual trials”). Your study’s sponsor will explain all the details for your particular trial so you know exactly what to expect.  If travel to the study site is required, your sponsor can answer questions about support with travel financing and logistics.  What Happens When the Trial Is Over? It can take years from the start of a clinical trial to when the study is completed and all data are reviewed and analyzed. Stay in touch with your sponsor contact about study results, realizing that the final results of any study may take quite a long time to be released.  In the meantime, work with your sponsor, patient advocate, and/or your trusted medical team to continue your clinical trial journey.  Want to learn even more about what it’s like to participate in a clinical trial? Be sure to check out our other blogs to discover firsthand stories from patients like you as well as more information about how and why to participate. 

Give the Gift of Health Through Clinical Trial Participation 
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Give the Gift of Health Through Clinical Trial Participation 

How do you give back? Whether you volunteer your time, donate to causes you believe in, or help your community in other ways, doing your part feels good. As you think of ways to make a difference, clinical research may not be the first thing that comes to mind. However, you may be shocked to learn just how much of an impact participating in a trial has.   Clinical Research Changes Lives  Clinical research is the process of making sure new medical discoveries are safe and effective. Participants — everyday people who either have a medical condition or who participate as healthy volunteers — make this process possible.  When you participate in clinical research, you can be a part of:   These positive effects ripple throughout communities. As a clinical trial participant, you can give the gift of health to a wide range of people. A new treatment that you contribute to through clinical research could save or improve the life of a friend or family member; it could also help a stranger across the country or make life better for future generations.   Paying It Forward  Even as clinical trials continue to improve medicine, the sad truth is that many people still can’t get the care that a lot of us may take for granted. Imagine if you could be a part of developing new treatments while also improving vaccine access for children in need. By participating in a clinical trial that partners with Greater Gift, you can do just that.   Greater Gift is a non-profit that spreads awareness of the benefits of clinical research and expresses gratitude for everyone involved in the process. They pay the gift of health forward by giving vaccines to children in developing countries through Gavi, The Vaccine Alliance. Greater Gift also partners with Feeding America to provide meals for children facing hunger. Through the clinical operations giving program, researchers can choose to donate on behalf of participants or other contributors.   Make an Impact on Global Health  If you are a research sponsor, partnering with Greater Gift can extend the impact of your trial. Showing gratitude makes a big difference for clinical trial participants. After all, these volunteers make research possible, and a simple thank you goes a long way in showing them you appreciate their contribution. When you pair this gratitude with a donation that pays their impact forward, it has an even greater effect.   If you are a potential clinical trial participant, you can help Greater Gift by increasing awareness of their mission. You can also donate to boost Greater Gift’s reach in bringing clinical research to more underrepresented communities. This work is only possible with the help of donors and sponsors.   A great place to start getting familiar with research is through our resource library. We’ve collected information from a variety of sources from trial participants to national health organizations and put it in one convenient place. Once you’ve learned more about how clinical research works, spread the word with our shareable assets. These graphics make it easy to amplify awareness among your friends, family, and professional network. It only takes a few minutes, but the effect can be significant.  

Different Types of Clinical Research and What They Mean for You 
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Different Types of Clinical Research and What They Mean for You 

Without clinical research, there would be no new treatments, no improvements in our understanding of how diseases work, and no new options for prevention. In short, clinical research is essential.  Not all research is the same. There are two broad types: observational and investigational. They each have different goals and work in different ways, but they both rely on people like you to participate and spread the word.   Read on for an overview of observational and investigational clinical research and learn how you can get involved.   Observational Research: Observing Health Patterns  Observational research gathers data and looks for patterns. If participants have a medical condition, they will continue their usual treatment plan during an observational study. Participants in this type of research do not receive new treatments. Instead, researchers observe and record various data, depending on the goal of the study, while the participants keep their general routine the same.   Participation may involve filling out a survey, meeting with a researcher for an interview, or providing a blood or tissue sample.   Types of Observational Studies  Who Can Participate?   Each observational study will have unique requirements based on what the researchers are interested in. In many cases, both healthy volunteers and people with a specific condition are needed.   Since observational research does not require you to take a new medication or change your routine, you can often participate in multiple observational studies at one time.   Why Does Observational Research Matter?  Observational clinical research provides essential information about how diseases work and what risk factors could be. Each new study gives more information, and it takes many studies over a long period of time to clarify possible links between behaviors and diseases.   What does this mean in the real world? For one, it can help people make more informed decisions about their lifestyles to have a better chance of staying healthy. Recommendations like increasing physical activity, maintaining a balanced diet, and avoiding smoking all have their roots in observational research.   Observational studies can also identify factors outside of an individual’s control that increase the chance of developing a certain disease. This gives doctors the information they need to screen for those conditions sooner, potentially improving and saving lives.   Investigating Research: New Treatments  Whereas observational research gathers information about health, investigational research (i.e., clinical trials) puts this information into practice and tests new ways to prevent, diagnose, manage, and cure diseases.   During a clinical trial, researchers monitor participants to ensure safety and track whether the new treatment works correctly. Depending on the trial, participants may go to a specific location (a trial site) to receive treatment, or a health care professional may monitor them while they undergo treatment at home.   Clinical Trial Phases  Clinical trials have four phases, and each serves a specific purpose.   Who Can Participate?   Like observational research, different trials look for various traits among participants. Along with looking for people with the health condition the treatment will target, clinical trials may have other requirements depending on the specific goals.   The phase of the trial also changes who can participate. Phase I trials often involve healthy volunteers, as this gives the opportunity to study safety before involving those whose disease may make them more likely to have negative effects.   Why Does Investigational Research Matter?  Any advancement in medicine that you can think of owes its creation to clinical trials, from the most common over-the-counter medications to innovative treatments for serious conditions. Investigational research is essential to determine what treatments are safe and effective. Clinical trials can also provide options for those who don’t have many other treatment choices, like those with rare diseases.   Ready to Get Involved?   Whether you’re interested in taking part in observational or investigational research, you have the power to make a real difference for the future of medicine. You can ask your doctor about studies or trials that may be right for you, or you can use an online tool like Carebox, Antidote, or ClinicalTrials.gov to start your search.   And if participating directly isn’t the right choice for you now, that’s okay too! You still can do your part by sharing information and staying informed. You never know who in your network could benefit from this knowledge.  

Clinical Trial Myth Busters: Get the Facts About Research
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Clinical Trial Myth Busters: Get the Facts About Research

How much do you know about clinical trials? If the answer is very little, you aren’t alone. 41% of Americans know nothing about clinical research.   If you haven’t heard of clinical trials at all, they are how researchers test new medical treatments and drugs to make sure they are safe and work well. Trials are essential for any new medicine to become available.   If you have heard of trials before, it’s possible some of the things you’ve been told aren’t actually true. There are many clinical trial myths out there, but we’re here to help clear up the confusion.   Keep reading to learn the truth about five common research myths.   Myth: Only very sick people participate in clinical trials  Fact: Many people can take part, even healthy ones  Some people think that clinical trials are only for people with serious, life-threatening conditions and no other treatment options. It’s true that trials can provide vital hope by offering new treatments that aren’t available elsewhere. However, there are many types of research available, and you don’t need to have a severe condition to take part.   Each trial has specific rules about who can join. Researchers may need people at different stages of a condition, from early to advanced, and for both common and rare diseases. Healthy volunteers are also needed in some cases.   The bottom line: don’t rule yourself out of clinical research completely. Although not every trial will be the right fit, many could be.   Myth: Clinical trials treat participants like lab rats  Fact: Participants are respected and protected   One unfortunate myth is that clinical trials are dangerous and that people who participate are treated like test subjects or even “guinea pigs.” The truth is that participants’ rights and safety are well protected.   There are many different rules in place to ensure trials are safe. While risk levels can vary, researchers must explain these risks and work to reduce them. Steps to do this include regular checks throughout the study and ways to report any problems quickly.   Myth: You can only participate from a big city   Fact: Technology opens more ways to join trials   If you don’t live in a major city, you might think there aren’t any clinical trials near you. There is a bit of truth that many trials are often hosted at large hospitals or universities in big cities. However, advances in technology are changing this.  More trials than ever before involve local doctors or even allow you to participate from your home. These options are not available for all trials, but there are more opportunities to take part in research than you might expect, and you don’t always need to travel to a big city. And if you do need to travel, you can find studies that will cover the cost and help with planning.   Myth: Your doctor needs to refer you to a trial  Fact: You can find and join studies on your own  You may think that the only way to get into a clinical trial is through your health care provider. While talking to your doctor about research is a great place to start, it is not the only option. However, you may learn after talking to your doctor that they aren’t involved in or familiar with clinical trials. In this case, it’s important to know that it doesn’t need to be the end of your research journey.   Tools like Carebox, Antidote, or ClinicalTrials.gov allow you to search based on your health condition. You can also add filters to find trials that might be a good fit. Once you see one that could be an option, reach out to the contact for that trial to ask questions and learn more.   Depending on your condition, you may also be able to work with a patient advocate who will search for trials for you and help you throughout the process. You can find an advocate through non-profit organizations related to your illness or, in some cases, through your health care provider.   Even though you don’t need your doctor to refer you to a trial, you can still ask them about how participating might affect your current care.  Myth: Getting involved is too complicated   Fact: Resources can make the process easier   At first, it may seem like you need to be an expert to find and take part in a trial. However, the good news is that this isn’t the case. People from all backgrounds participate in research — and you can, too. There are many resources available to help make this process easier.  Our Resource Library is a great starting point. We’ve collected information from trusted sources about a wide variety of clinical research topics, and you can search based on what you want to learn.   Even if you are not interested in participating in a trial, there are still ways to get involved. Just by reading this blog and sharing what you’ve learned, you can help more people understand the truth behind clinical trials.