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.
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.
Source: Touch BBCA