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Do We Need Clinical Trials?

Have you ever wondered how new medicines make it to your local pharmacy? Or how doctors know which treatments work best? The answer is clinical trials. But with all the advances in science and technology, you might be asking: do we still need clinical trials? The short answer is yes, and here’s why. 

What Are Clinical Trials? 

Clinical trials are carefully designed tests for new medical treatments. They help researchers determine if a new medicine or therapy is safe and effective. Think of clinical trials as a bridge between a promising idea and actually using it to help people.  

What’s the Point of a Clinical Trial? 

Clinical trials aim to answer some key questions about a new treatment: 

  1. Does it work? 
  2. Does it work better (or the same as) existing treatments?
  3. Is it safe?
  4. Are there any side effects? 

To answer these questions, researchers follow a strict plan; however, the specifics of how each trial works depends on the treatment being tested, the phase of research, and other factors, but typically, clinical trial participants are divided into groups. One group receives the new treatment, while another might receive the current standard treatment or a placebo (an inactive substance that looks like the real treatment). Researchers then closely monitor participants in each group to understand the treatment’s effects. 

Why Can’t We Skip Clinical Trials? 

We now have powerful computers, sophisticated lab tests, and the ability to study new treatments in animals. So, why aren’t these methods enough? While these preclinical studies provide valuable information before starting trials, they can’t fully predict how a treatment will behave in humans. Our bodies can react very differently than animals or cells in a test tube. Only human testing can reveal a treatment’s real-world effectiveness, its impact on daily life, and any long-term side effects. 

How Do Clinical Trials Keep People Safe? 

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Doing anything new can be overwhelming at first, including joining a clinical trial. But there are many ways researchers work to keep participants safe: 

  • Careful planning: Before a trial starts, researchers do many other tests to make it as safe as possible  
  • Close watching: During the trial, doctors keep a close eye on everyone’s health 
  • Clear information: Participants learn all about the trial before they join, including any risks
  • The right to stop: People can leave a trial at any time if they want to 

Why Your Involvement Matters 

Diverse participants are important for clinical research — both healthy volunteers and those with specific health conditions, depending on the trial. This diversity helps ensure that new treatments are effective for everyone. By joining a trial, you contribute to potentially lifesaving discoveries. Even if a treatment does not work, the information gained helps researchers move closer to finding better solutions. 

Clinical trials can also provide early access to promising new treatments for individuals facing limited treatment options. This can be a valuable opportunity to receive cutting-edge care. 

How Can You Get Involved? 

We need clinical trials, and clinical trials need participants! How can you do your part? Getting more information is a great place to start. Our Resource Library includes a variety of topics related to research, and you can search based on conditions or topics you are most interested in.  

If you’re considering participating in a trial, talk to your doctor. They might know about trials that could be right for you. You can also search for trials using online tools, like ClinicalTrials.Gov.  

Even if participation isn’t right for you, you can still do your part by spreading the word. Tell your friends and family about the importance of clinical trials. You never know who could benefit from this information.  

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14 Ways to Support Your Mental Health During a Clinical Trial
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14 Ways to Support Your Mental Health During a Clinical Trial

By: Meredith Boley, Bezyl For people struggling with their mental health, support can be life changing. The same is true for people who participate in clinical trials!  The clinical trial environment, which can sometimes lack adequate psychological support and resources, often creates or compounds mental health struggles. As a result, both patients and caregivers may feel isolated, overwhelmed, and unsupported.  Unpacking the Patient Experience  Clinical research participants can experience heightened levels of stress, anxiety, uncertainty, and even depression. This is primarily due to the unfamiliarity of the trial process, potential side effects of treatments, concerns about their health outcomes, and because they are often managing a significant illness or condition while navigating trial complexities that their social circle may not fully understand.   Caregivers Face Mental Health Challenges, Too  Caregivers of clinical research participants can also face unique mental health challenges. They may experience high levels of stress and anxiety due to the demands of caregiving, concerns about their loved one’s health, and the emotional burden of supporting someone through a clinical trial. Caregivers may also experience feelings of isolation, fatigue, and burnout, especially if they lack a support network or resources to help them manage their caregiving responsibilities.  Why It Matters  Patient and caregiver mental health during clinical trials is important because it directly impacts both groups’ overall well-being, which can affect a patient’s ability to stick to the trial protocol and to manage treatment-related side effects. When mental health is compromised, patients may experience reduced motivation, increased fatigue, and a decline in physical health, impacting trial outcomes and data reliability.   Furthermore, strong mental health support can enhance retention rates, reduce dropout rates, and help ensure the trial’s success. By addressing mental health proactively, both patients and caregivers are better equipped to handle the emotional and psychological demands of participating in a clinical trial, leading to more accurate and reliable study results – which ultimately deliver better treatment options to the people who need them.  14 Clinical Trial Mental Health Tips  With this in mind, here are 14 ways that patients and caregivers can give their mental health a boost while navigating clinical research participation.  Establish a Routine: Maintaining a consistent daily routine can provide a sense of normalcy and stability, which can help reduce anxiety and stress. This includes regular sleep, exercise, mealtimes, and scheduled relaxation or leisure activities.  Stay Informed: Understanding the clinical trial process, potential side effects, and expectations can help reduce fear and anxiety. Patients should feel empowered to ask questions and seek clarification from their healthcare providers. Knowledge about the trial can help patients feel more in control of their situation.  Access Professional Mental Health Support: Engaging with a therapist, counselor, or psychologist who specializes in working with clinical trial participants can provide tailored emotional support and coping strategies. Professional support is invaluable for managing anxiety, depression, or other mental health concerns that may arise.  Practice Self-Care: Self-care activities, such as reading, journaling, meditating, or engaging in hobbies, can help manage stress and improve overall well-being. Taking time for oneself is crucial for maintaining mental and emotional balance during the demands of a clinical trial.  Physical Activity and Exercise: Regular physical activity is proven to boost mood, reduce stress, and improve overall mental health. Even light exercise, such as walking, yoga, or stretching, can help alleviate anxiety and depression symptoms and improve physical health, which can be particularly beneficial during clinical trials.  Nutrition and Hydration: Eating a balanced diet and staying hydrated can significantly impact mood and energy levels. Good nutrition supports brain health and overall well-being, which is important for maintaining a positive outlook and physical health during a clinical trial.  Build a Support Network: Build a support network that includes healthcare providers, fellow trial participants, friends, family members, and community groups. This network can offer emotional support, practical advice, and a sense of solidarity.  Set Realistic Goals and Expectations: Setting achievable personal goals can provide a sense of purpose and accomplishment. It’s also important for patients to set realistic expectations about what they can handle and to recognize their limits to avoid burnout or frustration.  Practice Mindfulness and Relaxation Techniques: Techniques such as deep breathing, meditation, progressive muscle relaxation, and visualization can help reduce stress and anxiety, improve focus, and promote a sense of calm. These practices can be especially helpful for managing the emotional ups and downs that come with clinical trials.  Keep a Journal: Writing down thoughts, feelings, and experiences can be therapeutic and help patients process their emotions. Journaling can also be a useful tool for tracking emotional states as well as identifying patterns and triggers of anxiety or stress.  Engage in Positive Social Activities: Participating in social activities or connecting with friends and family can help reduce feelings of isolation and provide emotional support. Engaging in positive, supportive social interactions can improve mood and provide a sense of normalcy.   Stay Connected with the Research Team: Maintaining open communication with the clinical trial research team can help address concerns or issues as they arise. Feeling supported and heard by the research team can alleviate stress and improve the overall trial experience.  Create a Calming Environment: Having a designated, comfortable space for relaxation or mindfulness practice can help manage stress and provide a refuge during difficult times. This environment can include calming elements like soft lighting, soothing music, or aromatherapy.  Connect with Support Communities: Connecting with others in similar situations can help reduce feelings of isolation and provide valuable peer support.   Find Mental Health Support Tools That Work for YOU  Creating a supportive environment on your own can be challenging, even with the above tips. That’s where support tools come in! Bezyl is an app that offers a personalized platform for mental health tools. Designed to support clinical trial participants and caregivers – as well as other people who’ve experienced trauma – the app includes features like:   Mental well-being is crucial for navigating the challenges of a clinical trial, maintaining resilience, and improving overall outcomes. Don’t hesitate to seek support, whether through Bezyl, healthcare providers, or your personal network.  More About Bezyl: Clinical Trials For All partner Bezyl was founded with a mission to revolutionize mental health support by leveraging the power of connection and community. Our vision is to create a world where mental health support is accessible, personalized, and integrated into everyday life. Our app, available on Google Play and the Apple Store, offers a comprehensive suite of tools designed to support mental well-being. From connecting with family and friends through our Spheres of Support feature to tracking moods and accessing a library of resources, Bezyl is here to help you every step of the way. Visit Bezyl.com. 

Clinical Trial Story Time: A Friendly Intro for Your Child
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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.  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 …  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.  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!  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. 

LGBTQIA+ Research Participation: Why It Matters and How You Can Help
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LGBTQIA+ Research Participation: Why It Matters and How You Can Help

Have you ever wondered how new medicines and treatments are developed? The answer is clinical trials. These studies test how well new medical approaches work, and they are an important step in bringing new treatments to people who need them.   For these trials to work best, research participation needs to include all kinds of people: from different racial or ethnic backgrounds, across different regions, and different sexual orientations and gender identities. That’s where you come in. If you’re part of the LGBTQIA+ community, your participation in clinical trials is more important than you might realize. Your experience and your health matter. By participating in clinical trials, you can help shape the future of health care for yourself and your community, now and for generations to come.   Why LGBTQIA+ Trial Participation Matters  Historically, LGBTQIA+ individuals have often been left out of medical research. This means that fewer LGBTQIA+ people have been involved in studies compared to the percentage of people who are part of the community overall.   This lack of representation has a real impact. LGBTQIA+ people often face unique health challenges. For example, studies show higher rates of certain cancers and mental health conditions in some LGBTQIA+ groups. By participating in clinical trials, you can help researchers better understand these differences and develop treatments that work for everyone.  There are also some health concerns that are specific to LGBTQIA+ individuals. For instance, transgender people may have unique needs related to hormone therapy or gender-affirming surgeries. When LGBTQIA+ people are included in research, it helps health care providers offer more informed, compassionate care to all patients, including those with diverse sexual orientations or gender identities.  Challenges and Solutions in LGBTQIA+ Clinical Research Participation  LGBTQIA+ individuals may face some unique challenges when it comes to clinical trials. But for each challenge, researchers, organizations, and communities are working on solutions, as reported by Citeline:   By getting involved in clinical trials, you can also be part of the solution! Your participation helps researchers learn how to make trials more inclusive and accessible. It also sends a message that LGBTQIA+ health deserves attention.  Benefits of Participating in Clinical Trials  We’ve talked about why your participation matters for the LGBTQIA+ community as a whole, but there are also many potential benefits for you as a participant:  Every clinical trial is different, and the benefits can vary. It’s important to discuss the potential benefits and risks with the research team.  How to Get Involved in Clinical Trials  Ready to take part in a trial? Here are some ways to get started:   Remember, you always have the power to choose which studies you want to be part of and to ask for what you need during the process.  You Can Make a Difference  LGBTQIA+ participation in clinical trials is crucial for advancing health care that truly serves everyone. While there may be challenges in participating, there are also organizations and researchers working hard to make clinical trials more accessible and inclusive. By getting involved, you can become part of this positive change.  Whether you decide to participate in a clinical trial, share this information with others, or simply learn more about LGBTQIA+ health research, you’re taking an important step. Every action, no matter how small, contributes to a future where health care truly serves all of us. 

How Can You Contribute to Clinical Research as a Healthy Volunteer?
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How Can You Contribute to Clinical Research as a Healthy Volunteer?

Did you know that medical treatments, from the newest to the most well-known, all have something in common? That something is the clinical research process. Before any new treatment becomes widely available, it has to go through this process to make sure it’s safe and effective.   For clinical research to take place, there needs to be participants: everyday people who get involved. You may assume that everyone in a trial has a medical condition. After all, it would make sense that to test new treatments, there needs to be a disease or condition to treat. While people with relevant conditions definitely do participate, clinical research needs healthy volunteers too!   Read on to find out why healthy people play a key role in research and learn how you can get involved.   First Things First, What Is Clinical Research?   Before we get into how healthy volunteers contribute to clinical research, we need to cover the basics. What exactly is clinical research? In short, it’s the process of studying new discoveries in medicine to find out how they can help patients.   Some types of clinical research are observational, meaning they gather health information and look for patterns. Clinical trials, on the other hand, test something new: a medication, device, procedure, etc. Before this new discovery can become available to the public, the clinical trial process tests that it is safe and does what it’s supposed to do as well as or (ideally) better than existing options.   The Phases of a Clinical Trial  The clinical trial process is split into different phases: I — Pre-Clinical/Phase 0 (Pre-Clinical) — Before testing in humans, scientists study the new discovery in the laboratory II — Researchers find the right dose and gather information about safety, often using healthy volunteers III — These trials evaluate effectiveness and side effects in the population that will eventually use the product  IV — This phase continues to confirm that the product is safe and effective, compares it to any currently available options, and monitors potential negative effects  V — After the FDA approves the new product and it hits the market, it is still monitored to see if new side effects and risks develop and if it continues to be effective  So, Why Use Healthy Volunteers in Clinical Trials?   In observational studies, healthy volunteers can serve as a comparison to participants who have the condition researchers are studying. In clinical trials, healthy participants are usually involved in Phase I. This is because in many cases, patients who have the condition the new product aims to treat are more at risk during these early steps.   However, Phase I trials don’t always involve healthy participants. It depends on the specific risks. For example, cancer-related trials will often use patients with the targeted type of cancer, even in Phase I.   In some cases, like vaccine trials, healthy volunteers participate across all phases.   Can Anyone Be a Healthy Volunteer?   “Healthy volunteer” may seem like a pretty straightforward description, but the exact definition and who qualifies will depend on the specific trial. Researchers specify requirements for age, weight, medical history, and sex. They’ll perform a screening process, which may involve asking questions and/or a medical exam similar to an annual checkup, to confirm that you’re eligible. Just because you don’t meet the criteria for one trial doesn’t mean you can’t be a healthy volunteer in a different one.   One common misconception is that women can’t participate in trials — this is not the case! While the FDA prohibited women of “childbearing age” from participating in Phase I trials from 1977 to 1993, there are no current restrictions. Having more women participate in trials is essential for making sure new drugs and products are safe for both men and women. That being said, some trials may restrict participants based on sex depending on the specific risks.  The Benefits of Trial Participation   While healthy volunteers don’t receive focused treatment for a condition they have during a trial, this doesn’t mean they don’t receive any benefits.   One of the biggest reasons people choose to participate is to help others. Without clinical trial participants, there would be no new treatments or cures for diseases. By taking part, you are saving and improving lives in your community and beyond.   Additionally, clinical trials almost always involve financial compensation for healthy volunteers. The payment depends on the trial, but compensation can be up to thousands of dollars.  Understanding the Risks  It is impossible for trials to guarantee there won’t be any negative effects. This is one reason healthy volunteers are compensated, because researchers understand that they are taking a risk by participating. However, researchers have a duty to minimize risk and keep participants safe, and there are strong safeguards in place, like monitoring by medical professionals, to ensure trials are conducted responsibly.   Informed consent is crucial in clinical trials. This means that researchers need to clearly communicate any and all risks to you. If you have any questions or don’t fully understand something, ask. Additionally, keep in mind that you can stop participating at any time, even once a trial has already started.   Ultimately, the decision to participate in a trial is a deeply personal one. Only you can decide what is right for you.  Okay, I’m Interested — How Do I Get Involved?   If you think participating as a healthy volunteer is right for you, the first step is researching available trials that you could qualify for. Clinicaltrials.gov is a great place to start. You can search specifically for trials that are taking healthy volunteers and filter based on your location and other criteria. Other search tools, like Antidote, can also help find trials near you.   Additionally, you can explore the various resources on our site to keep learning more about trials and how you can get involved, whether you choose to participate or simply spread awareness. Thank you for being a part of the future of medicine.  

Neurodivergent and Participating in a Clinical Trial? These Tips Can Help.
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Neurodivergent and Participating in a Clinical Trial? These Tips Can Help.

By: Heidi Green, COUCH Health Navigating the medical system as a neurodivergent person can sometimes be difficult. Many spaces and interactions aren’t as accommodating as they could be — and the same can be said of the clinical research space. However, there are ways to make trial participation less stressful.  Ask For Accommodations  One of the most effective things you can do to make your clinical trial experience work better for you is to ask for what you need. Here is a sample list of the kinds of accommodations that your clinical research team should be able to provide you with. Feel free to share this with them, or customize it to meet your individual needs.  Examples of What to Ask For  More Neurodiverse Research Starts with You  Keeping research teams accountable and ensuring that gatekeeping and implicit bias don’t exclude patients who should be included is essential to an improved research landscape. While such barriers have certainly posed a challenge to participation in the past, now is the time to change that.