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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?  

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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.  

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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. 

Tips for Searching for Clinical Trials as a Caregiver
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Tips for Searching for Clinical Trials as a Caregiver

If you are a caregiver, you aren’t alone; according to the Caregiver Action Network, over 65 million people in the U.S. (about 29% of the population) provide care for a chronically ill, disabled, or elderly family member or friend. The role caregivers play is different for everyone, whether it involves helping with a few tasks or full-time, live-in care. Across this spectrum, it’s clear that caregiving is essential for our communities and deserves recognition and support.   Caregivers help their loved ones in many ways, but one that may not come to mind at first is finding clinical trials. Enrolling the person you are caring for in a clinical trial can help them find new ways to manage their health, while also benefiting others with the same condition. If you’re interested in learning more about how clinical trials work and your role in finding a trial as a caregiver, the information in this article can help you get started.   What You Should Know About Clinical Trials  Before we explore more details about finding clinical trials as a caregiver, we should first discuss what clinical trials are.  A clinical trial is the process of testing a new treatment option, such as a medication or device. Trials happen in different phases, starting with smaller groups and progressing to larger ones. Throughout every step of the process, researchers follow strict standards to make sure they collect accurate data and keep participants safe. If the trial shows the new treatment is effective, it can be approved to become available to more people.   What does this mean for your loved one? Clinical trials often provide access to treatments that are not available anywhere else, giving them a new option to manage their condition. In addition to the personal benefits, taking part in a trial is also a valuable gift to others with the same condition. It gives hope for new treatment options that wouldn’t be possible without research.   How to Find a Clinical Trial Once you’ve decided that you’re interested in a clinical trial for someone close to you, the next step is exploring trials that could be a good fit. The process can seem overwhelming at first, but the good news is that there are many resources that can guide your journey and support you along the way.   Your loved one’s doctor is a great starting point for discussing clinical trials. Although not all doctors are involved in clinical trials, they will be able to answer some of your questions about the process and how it could fit with any current treatment(s). In some cases, they could recommend a trial that they are involved in or familiar with.   Even if your loved one’s doctor is not involved in trials, there are still many ways to find options. Sites like Carebox, Antidote, and ClinicalTrials.gov are great resources for searching for trials. You can look based on a condition and see key details about the trials within these tools.   From Searching to Finding the Right Fit  During this process, there are many elements to consider when deciding whether a trial is a good fit for the person in your care.   Each trial has different rules for who can participate. This may include how far along the disease is, whether your loved one has or does not have certain symptoms, other conditions, age, and a variety of other factors. Be sure to have their medical history available as you search. If you have any questions about whether a trial could be a good fit, reach out to the contact for that trial. They can talk through requirements with you and give you more details about the kind of participants the trial is looking for.   You should also consider the impact participation may have on you as a caregiver. Is the trial nearby? Will you need to travel to take your care recipient to appointments? Are there options to participate from home? This can help you plan to make sure participating is manageable not only for your loved one, but also for you. Many organizations in the clinical research community are working to improve access. The trial organizers may be able to point you in the direction of resources to help make participation easier, such as patient advocacy networks or support groups for caregivers.  Answers to Your Clinical Trial Questions Throughout the process of finding trials for someone in your care, communication is key. If you have questions, be sure to speak up. Researchers understand the key role participants play, and they should support you in finding the answers you need.   Our Resource Library is also a valuable tool for finding more information about clinical trials. Whether you are actively searching for trials for your loved one or are just starting to look into clinical research, you can make a life-changing impact by learning more and spreading the word.  

Improving Your Access to Clinical Trials — And Why It Matters
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Improving Your Access to Clinical Trials — And Why It Matters

By: Scott Stout, MedVector Think of the biggest medical breakthroughs of the modern era. Anything you can name, from the end of smallpox to the recent development of COVID-19 vaccines, owes its existence to clinical research.   Clinical research uncovers new or improved treatments for both rare and common conditions, and clinical trials confirm their efficacy and safety in humans. Both clinical research and clinical trials are essential for moving medicine forward, saving lives, and increasing quality of life for you, your loved ones, and your community.   By understanding what clinical research is, why it matters, and how to break down barriers to participation, you can become part of this essential process of discovery. And why should you consider it? Participating in a clinical trial can help improve the health of people everywhere, and it’s easier than you may think.   What Is Clinical Research?   Clinical research is a scientific process that examines new treatment options and/or new observations about health and illness in people. Clinical research can also include observational studies. These studies look at medical data and/or biological samples, but do not test new treatments. Then, through clinical trials, researchers confirm potential benefits and identify risks of new drugs and therapies before making them available to the public.   The clinical trial process happens in phases. Every step of the way, researchers must follow strict standards to prove efficacy and patient safety. Once a clinical trial demonstrates a new treatment is safe and effective, patients everywhere can begin to access its benefits.   Why Are Clinical Trials Important? Clinical trials are the backbone of medical progress. They take discoveries from the lab into practice, bringing the latest developments in medicine and technology to communities like yours. Without clinical trials, medicine simply couldn’t evolve, and, more importantly, treatments that save and improve lives wouldn’t be able to reach the people who need them.  How You Benefit From Clinical Trials   The benefits of clinical trials for science as a whole are clear, but what about the benefits for people who participate in these trials?   Clinical trial participants benefit in many ways. You:   Barriers to Clinical Trial Accessibility   If clinical trials are so essential, why have 91% of Americans never participated in one?  Some barriers to trial access and participation include:   But what if the doctors you already know and trust could offer clinical trials as a care option? Even considering the barriers to clinical research, studies suggest 75% of patients would participate in a clinical trial if it were recommended by their doctor. Knowing this, an obvious conclusion to patient-centric participation in clinical research is … our doctors.   However, not all doctors want to get involved in research, and the ones that attempt to do so typically stop. Underenrollment, paperwork, and strict compliance guidelines create additional work, requiring doctors to dedicate a significant portion of their resources to keep running trials, let alone be profitable.   Why Don’t Doctors Just Refer Their Patients to Clinical Trials? In a perfect world, doctors would refer their patients into clinical trials, but even after addressing the awareness problems, several factors prevent this:   Clinical Trials as a Care Option  We know that patients want to hear about clinical trials from their trusted doctors, but current avenues to provide access are not ideal: either become an investigator or refer a patient (customer) to another doctor. So how do we bridge this gap and align the interests of patients, clinical trial sites, and treating physicians?   A decentralized clinical trial (DCT) gives patients access to clinical trials from alternative locations, such as their home or local clinic, but in an industry that values “caution” over “innovation,” the process of putting DCTs into practice has been painfully slow.  At the peak of the COVID-19 pandemic, telemedicine, a decentralization tool in the telehealth family, became common practice and has continued to be widely used. Telehealth is the delivery of health care services or monitoring by video, messaging, or other options that don’t require a physical visit to a doctor’s office. A unique benefit for clinical research is that telehealth enables a patient to be in two places at once: physically at their doctor’s office, while virtually at a clinical trial site. This concept allows patients to access advanced medicines from a variety of locations including, not only treating physician’s offices, but also local labs or pharmacies.  Even more importantly, by enabling treating physicians to “host” clinical trial appointments from their local practice, it reduces the referral concerns of patient leakage, lost revenue, and control of care. Under this model, patients have increased access to research while their doctors become part of the referral, continuing to be the primary caregiver for the patient.  Get Involved in Clinical Research  If you’re a patient interested in moving the needle toward clinical research as a care option, you can start by talking to your doctor. Ask them if they’re familiar with clinical trials and if they’re aware of the new technologies bringing them to local communities like yours. Even if they aren’t currently involved in research, this question could spark your doctor’s natural curiosity and pave the way for future access to new care options, which is good for everyone!   Our website also has a variety of resources for you to explore, including tools to search for trials near you. As clinical research continues to evolve and become more accessible, you can help be part of the future of medicine by getting involved. 

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. 

Do We Need Clinical Trials?
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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:  Does it work?  Does it work better (or the same as) existing treatments? Is it safe? 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?  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.