Before they become widely accessible, new treatment alternatives can be accessed through clinical research. Participants receive close monitoring and health care at leading medical facilities. Before you agree to participate in a study, you should be fully informed about the advantages and disadvantages of the trial. The research team should be able to answer all of your questions.
Only certain kinds of patients can participate in a trial to get meaningful results. These characteristics are called eligibility criteria. The criteria can be quite strict. For example, some tests exclude people who have a particular genetic mutation or severe liver disease. The criteria may also exclude people who take certain medications, which could interfere with the experimental drug. Eligibility criteria are meant to protect participants from unnecessary risks. But they can have other unintended consequences. For instance, it took Patty Spears three attempts to get into a cancer vaccine trial because she didn’t meet the strict eligibility requirements for the first two trials. Spears felt the conditions were unfair, especially since they disproportionately excluded older and healthier people.
Another concern is that eligibility criteria can limit participation in clinical trials, which can negatively impact the health of people around the world. Research shows that it’s important to have as many eligible people participate in trials as possible. To improve this, groups are developing guidelines to help researchers broaden their eligibility criteria without compromising patient safety. These efforts are encouraging, but more work needs to be done. Some people say that one of the reasons you should participate in clinical trials is that it offers access to specialized care and treatment that they wouldn’t otherwise have, such as closer follow-ups with the research team or new medications before they are approved for use by doctors.
Although there have been rare patient deaths related to clinical trials, experts say most clinical trials have impeccable safety records. The study team will discuss any risks before receiving your consent to participate in a clinical trial. It is called informed consent, a necessary step in participating in medical research. Depending on the type of clinical trial, you may be randomly assigned to receive either experimental treatment or standard care. If the researchers do not know which treatment is better, they cannot determine if one is more effective or has fewer side effects. In addition, the new treatment may not work for you and could cause unpleasant or life-threatening side effects.
If you participate in a clinical trial, your healthcare providers will follow your progress carefully. Depending on the study, you may be asked to keep a diary, attend regular appointments or clinic visits, and complete questionnaires. It may add to your overall healthcare costs. Generally, information about your participation in the clinical trial is confidential. However, the research institution conducting the study and its sponsors or contract research organizations will have access to this information. It is to protect your rights and ensure the integrity of the research.
Whether or not you get paid for participating in the trial is a decision made by the clinical trial sponsor and will be outlined during the informed consent process before the study begins. Participants may sometimes be reimbursed for expenses like mileage or food. The research team will help find a trial to match your needs, and they can work with your regular doctor to schedule the time needed for both your care visit and the trial. People who participate in clinical trials often feel like they are taking a more active role in their health. Some of them can gain access to new treatments that aren’t yet available to others. In addition, participants believe their participation in clinical trials can help scientists better understand their disease or condition, leading to future treatment advances and a better quality of life. However, there are concerns about the ethical implications of compensation in clinical trials. One of the main concerns is that compensation can serve as an undue inducement to participate, and it can cause participants to neglect other important factors in their decision to participate, such as the risks involved. Similarly, compensation can encourage some people to hide important data that might make them ineligible for the study or could negatively impact other participants’ safety.
For patients with a disease or condition, clinical trials offer the potential to be among the first to benefit from a new treatment. It is also an opportunity to help others and contribute to medical knowledge. Each research study has a specific protocol, and members of the research team explain all aspects of it to participants before they freely agree to participate.
In addition to giving people access to cutting-edge therapies, some research studies also provide the chance to receive extra care from a team of doctors and nurses who specialize in their condition. It can be a valuable alternative to standard care, especially for people who have tried and failed other options. Some studies use placebos, where the participant doesn’t get the experimental treatment but is still monitored by a doctor. Placebos are typically only used if the researchers believe that denying the patient a potentially life-saving treatment would not be ethical. While participating in a clinical trial may require more frequent and longer appointments or procedures, the medical teams involved in research are highly trained and have your best interests at heart. Most insurance providers also pay for additional doctor visits or testing and the cost of the drugs used in the study. They may even reimburse for mileage or travel expenses.