Clinical Trials 101: Your Guide to Alzheimer's & Research

Each year thousands of clinical trials occur. Learning about clinical trials can feel like you are learning a new language. The good news is that there are lots of resources to help support and guide decision-making before enrolling in a clinical trial. Check out 10 things to know about clinical trials and participating in trials. Clinical trials are the backbone of treatment breakthroughs Clinical trials allow researchers to understand the impact of a treatment. When it comes to treatments or drugs, clinical trials provide critical information about the drug’s safety and effectiveness. In addition, they can lead researchers down of path to develop other new treatments. Ultimately, clinical trials make a difference not just for today’s population, but also potentially to those who’ll be diagnosed in the future. Regulatory and ethics groups oversee clinical trials All places that conduct clinical trials have strict ethical duties to participants and regulations they must adhere to. In order to ensure that the ethical and regulatory guidelines are followed there is a team of people who are independent of the research team who are asked to review and oversee the clinical trial. This team of people is known as an Institutional Review Board (IRB), sometimes known as Independent Ethics Committee or Ethics Review Boards. The IRB must review the research protocol before any participants can enroll in a study. Risks and benefits are different for each person Each clinical trial has different risks and benefits that are explained in the study protocol. Since each participant is different it can mean that each person may experience the risks and benefits differently. For example, it could be possible that one participant may experience a side effect that another participant does not experience. The exact risks and benefits can be difficult to predict since a component of some clinical trials is exploring the impact of a treatment. During the Informed Consent Process, a member of the research team will review the risks and benefits of the clinical trial. There are several key players involved There can be lots of different people involved in clinical trials, but there are key players to know about. Key players include the Principal Investigator (PI), who is the lead researcher leading the clinical trial. There is the trial sponsor, who is paying for research to take place. The research staff, which can include doctors, nurses, social workers or clinical research staff who will work directly with people with Alzheimer's. Lastly, people with Alzheimer's and their caregivers, without these key players medical advances wouldn’t be possible! Participants are able to leave a trial at anytime If you enroll in a clinical trial and then find that you are no longer able to participate, you are allowed to drop out of the trial at any stage. Trial participants do not have to provide any reason for leaving if they do not want to. If a participant decides that they no longer wish to partake in the clinical trial it is the research team’s responsibility to remove the person from the trial in a way that is safe for the participant. The health and safety of participants is the top priority One of the primary responsibilities of the research team is the care and safety of participants who have volunteered for the trial. Researchers may go by unfamiliar titles, like Principal Investigator or Study Coordinator, but they are, also, doctors, nurses, and trained research professionals. As such, they monitor participant safety and well-being. They will adjust study-related care when they feel it’s in the participant’s best interest. This may mean withdrawing a participant from a clinical trial to prevent harm. There are rules about who can and cannot participate The factors that allow an individual to participate in a clinical trial are called the inclusion criteria. The factors that disqualify an individual from participating in a clinical trial are called exclusion criteria. Inclusion and exclusion criteria are typically based on factors such as age, gender, health status, previous treatment history, and other medical conditions. There is a lot of thought and time put into the development of inclusion/exclusion criteria as these factors may have an impact on the findings of the clinical trials. The inclusion and exclusion criteria are applied to all possible study participants equally before they enroll in the study. Clinical trials occur in various settings Clinical trials could take place at a hospital, a university, a community clinic, or a doctor’s office. In addition to a variety of sites, there are a variety of researchers. Some medical professionals devote their career to conducting clinical trial research, while other research professionals conduct research for some of the time and the remaining time they are providing care in a healthcare setting. Evaluating the safety and efficacy of new drugs is a multi-step process When you peek inside your medicine cabinet do you ever wonder the journey that a medication underwent in order to allow it to prescribed by a doctor and land itself in your cabinet? It’s a long journey and thorough one. Every potential treatment undergoes multiple phases of research, each with a different goal. In clinical trials that are studying an interventional drug, treatment, or therapy there is pre-clinical research that occurs in laboratories, usually with cells or animals. If the pre-clinical studies show promising results, the treatment team must get permission from the US Food and Drug Administration (FDA) to test in humans. The research team submits an Investigational New Drug (IND) application to the FDA and must be approved before any next steps. People have lots of different reasons why they participate There are numerous reasons to participate in a clinical trial. Some might decide to participate to gain access to new or alternative treatments. Others may join to have access to personalized and expert medical attention. Some may participate as it can provide access to medications and procedures at no cost to the participant. Some people are motivated to participate to contribute to advancing medicine. Choosing to participate in a clinical trial is an individual decision and each person may have their own personal reasons for deciding to take part in a clinical trial. [lead_gen showIfLoggedIn=“0” campaign=“shortcode” source=“site”] Medical research often uses clinical trials in order to find new information about diseases and treatments. Clinical trials are studies that evaluate a medical, surgical, or behavioral intervention.1 It is often used to see if a drug or medical device is safe or effective for people. It can also be used to see if new, potential treatments are more effective than the current standard treatments. Other clinical trials might evaluate screening tools or diagnostic tests, or study aspects of caregiving or coping. Clinical trials are valuable, and without them, new findings, especially with treatments, would be much harder to discover. Why join a clinical trial? People participate in clinical trials for a variety of reasons. Some people find it gives them a more active role in their own treatment, while others do it because they hope their participation helps researchers find new information or new treatments for their disease. Deciding to participate in a clinical trial is a personal decision, and it’s not right for everyone. There are often criteria for each trial as to who can join, which may include restrictions on age, stage of disease, type of disease, and any other medical conditions. What happens when I join a clinical trial? Each clinical trial is different, but here are some general things that might occur when you a participate in a clinical trial. The staff will explain to you the trial, and get your basic information. You will have the opportunity to ask questions, and then sign an informed consent form. You will then be screened to make sure you’re eligible for the trial. Once you’re found to be eligible, you will have an initial visit where a baseline evaluation will be done on your cognitive and/or physical skills and abilities, depending on what the trial is for.2 You will then be randomly assigned to the treatment or control group, and the trial proceeds accordingly. You will not know which group you’re in. You will have regular appointments for the treatments or evaluations, and you’ll be monitored closely. This will not take the place of regular doctor’s visits. A clinical trial tests new treatments, interventions, or medications to prevent, diagnose, or treat a disease.2 Clinical trials have different phases. Phase I trials test whether a potential treatment is safe. Phase II trials further test safety and begin to evaluate how well the treatment may work. Phase III trials are called double-blind, placebo-controlled studies. In these trials, the new treatment is compared to a placebo (an inactive compound, or “sugar pill”) or the new treatment is compared to a standard treatment - this is referred to as a control. The control is important so researchers can know if the new treatment is more effective than the standard treatment. These trials are also “double-blind,” which means the patients and the health professionals administering the treatment do not know whether the patient is receiving the test treatment or the placebo. Avoid bias so the study participants do not influence the results. Each trial is different, so if you have any questions, it’s best to talk with your contact at the trial or the primary investigator (PI) on the trial. If you ever want to leave the clinical trial, you can do so at any time, with no repercussions. You are not bound to the trial in any way. Finding a clinical trial If you’re interested in finding a clinical trial, talk with your doctor or health care provider. You can also go to ClinicalTrials.gov, as well as hospital websites.2 Many universities and research and teaching hospitals do clinical trials. Once you find one that you’re interested in, contact the study coordinator. There is usually some sort of basic screening appointment that will determine whether participating is even an option for you, and any initial questions you have can be addressed. An honest conversation with your primary provider for your Alzheimer’s disease is important, as a clinical trial might not be the best option for you at this time. Talk with them about whether they think it might be helpful and safe for you, as well as the risks and benefits of participating. [lead_gen showIfLoggedIn="0" campaign="shortcode" source="site" title="Sign up for emails from {{site-name}}:"], Making decisions can be tough, especially when they relate to your health! One decision you may face is whether or not participating in a clinical trial is right for you. There are several types of clinical trials, and each have different goals and requirements. So, while one clinical trial may not be a good fit for you, there may be others that are. If you’re thinking about exploring clinical trial options but still aren’t sure, ask yourself some questions to determine if a clinical trial might be right for you: Willing to work with a new healthcare team during the trial? While you can still see your doctor while enrolled in a clinical trial, you will also be seeing a new group of healthcare professionals who are working on the study. Clinical trials are conducted by a group of researchers. The lead researcher for a trial is called the principal investigator (PI), who is usually a medical doctor or other healthcare professional. The research team may also include other doctors, nurses, and researchers. This research team is usually different from the healthcare team you see for your regular care. It’s important to inform your usual healthcare team of the clinical trial you are thinking of participating in and to discuss how the process will work. Willing to follow the trial protocol? The clinical trial protocol is a detailed plan of what the trial will involve. When you agree to participate in a clinical trial you will sign an informed consent document, which outlines the protocol and any tests, procedures, or appointments that are expected of you. These expectations may impact your day-to-day life. When reviewing the trial protocol be sure to note when you will need to travel to appointments and how often you may be required to have tests or procedures, like blood draws or MRI scans. You may also be asked to stop taking medications you are currently on while you are in the clinical trial. Keep an up-to-date list of all medications, including over the counter medications, and show this to the clinical trial team to be sure you can continue taking them during the trial. Okay with potential unknowns? Some clinical trials are blinded, or masked, meaning that participants will not know what medication they are receiving. Some studies are double-blind studies, meaning both the participant and the research staff will not know what medications a participant is on. This is done to prevent any bias or influence and to allow the participant and researchers to measure the true effect of a drug. In blinded trials, you will be informed of all possible treatments that will be part of the trial, including no treatment (placebo). Before agreeing to participate, it is important to ask yourself if you would be okay with receiving any of the possible treatments, and if you could handle not knowing which treatment you may be given. Okay with the possible risks? The research protocol and informed consent document will outline your rights as a clinical trial participant. This document will note the potential benefits for participating in a clinical trial and will also note potential risks. Clinical research is approved and monitored by an Institutional Review Board (IRB) that ensures any risks are minimal. While the research team and IRB will do everything possible to minimize risks, it cannot always be guaranteed. It is important to take note of the potential risks you may incur and decide if these possible risks are worth the benefits. Will I be okay with the possibility of not being selected? Clinical trials are designed with certain criteria and researchers are often looking for a select group of participants with certain medical histories. These characteristics and medical histories are outlined in the trial’s inclusion and exclusion criteria. One of the main reasons people are excluded from a study is to maintain their safety. For some clinical trials, you may agree to participate and sign an informed consent document, but then be found to be ineligible for the trial after further testing. If you are not selected for a particular trial this does not mean that you cannot try and enroll for a different clinical trial. There may be other questions you have about clinical trials. You may want to talk with friends, family, and your doctor, or ask the community for their experience. Ultimately, it’s important you make a decision that you feel comfortable with. [lead_gen showIfLoggedIn="0" campaign="shortcode" source="site"]

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