doctor meeting with a patient
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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:  

  • Get to be part of something larger than yourself. You are contributing to a healthier world! 
  • Gain access to promising new treatment options not yet available for public prescription. This is an especially hopeful experience for those who have not found success with other available treatments.  
  • Receive health care through clinical trials at no cost.  

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:  

  • Lack of awareness: 41% of Americans are completely unfamiliar with clinical research  
  • Location: Many people are unaware or unable to find clinical trials near them 
  • Unknown risks: Some people worry that clinical trials are too risky, especially if they aren’t familiar with the safety guidelines researchers must follow  
  • Distrust: It takes time to build a relationship with a health care provider; it’s often difficult for people to trust researchers they don’t know 

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:  

  • Fears of patient leakage: Like any business, doctors don’t want to lose customers to another doctor or hospital 
  • Control of care: A referral happens when a doctor realizes they are not the best person to care for a patient; for example, a family physician might refer a patient to a cardiologist if they discover a heart condition, but rarely does a specialist refer to another specialist 
  • Additional workload: Not only are clinical trial sites asking doctors to refer, they are also asking them to search their patient database, contact patients, then refer away 
  • Lost revenue: As with any business, a lost customer means lost revenue 

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. 

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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. 

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.  

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.  

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.