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. 

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.  

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.