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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. 

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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.  

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. 

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.  

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. 

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.