Frequently Asked Questions

Participation in a clinical study depends on specific rules, known as "eligibility criteria," which determine who can or cannot join. Researchers establish these criteria in advance, using "inclusion" and "exclusion" guidelines to ensure the treatment is studied objectively and effectively. Eligibility may depend on factors such as age, gender, overall health, the type and stage of a medical condition, treatment history, and other relevant conditions. If you are interested in joining a clinical study, our team can assist in verifying your eligibility and answering any questions you may have.

Participating in a clinical trial offers several benefits, both to the individual and to society as a whole. At its core, a patient volunteer has a known health issue and chooses to take an active role in their healthcare by contributing to the advancement of medical knowledge. By participating, they help improve the understanding, diagnosis, treatment, or even the potential cure for their condition. In return, participants may gain early access to innovative treatments at no financial cost and are compensated for their time and visits. Beyond personal benefits, participants play a crucial part in advancing science and improving healthcare for future generations.

Informed consent for a clinical study is the process of providing potential participants with all the necessary information about the study. This includes details about its purpose, procedures, potential risks, and benefits, allowing individuals to make a fully informed decision about whether to participate. It ensures that participants understand the study and voluntarily agree to take part, prioritizing their rights and autonomy throughout the research process.

Participating in a clinical study comes with potential risks and benefits. The benefits may include access to new treatments before they are widely available, close monitoring by medical professionals, and the opportunity to contribute to advancements in medical research that may help others in the future. However, there are also risks, such as experiencing side effects, the treatment not being effective, or additional time and effort required for study-related activities. It’s important to weigh these factors and discuss them with the research team to make an informed decision about participation.

If you are currently taking any medications, it is important to inform our medical team by providing their names. This allows the team to assess whether there is any risk of negative interactions with the treatment being studied. They will advise you on whether it is safe to continue your regular medications while participating in the clinical trial.

The duration of a clinical trial varies depending on the specific requirements set by the sponsor for testing a particular treatment. Some trials may last only a few weeks, while others can extend over several years. The length depends on the study’s goals and design. Our staff can provide more details about the timeline of the study you’re interested in and eligible for, helping you understand what to expect.

Clinical trials are designed with safety as a top priority. Before a clinical trial begins, it must be approved and continuously monitored by both the U.S. Food and Drug Administration (FDA) and an Institutional Review Board (IRB). These organizations ensure that the study follows strict ethical and safety guidelines to protect participants. Researchers carefully plan each trial to minimize risks, and participants are closely monitored throughout the process. While there may still be potential risks, every effort is made to ensure the trial is conducted as safely as possible.

In general, participants are limited to taking part in only one clinical trial at a time. This is to ensure accurate and reliable results for the study and to protect participants from potential risks, such as interactions between treatments or overlapping side effects. If you are considering enrolling in a clinical trial and have participated in one previously, it is important to inform the research team so they can determine your eligibility and advise you accordingly.

Yes, you can choose to leave a clinical trial at any time, as participation is entirely voluntary. While you have the right to withdraw for any reason, it’s important to note that early withdrawal can impact the progress and results of the study. Your commitment to completing the trial is greatly appreciated, as it helps ensure the research achieves its goals. If you decide to withdraw, please inform the research team so they can guide you through the process and address any concern

No, participants do not need insurance to take part in a clinical trial, as these studies are typically sponsored by the industry. Clinical trials are focused solely on studying participants’ responses to new or innovative medical treatments and are not a substitute for regular care provided by a primary care physician. Participants are encouraged to maintain their usual healthcare routines while contributing to the research.

Participants in clinical trials may receive compensation for their time and involvement. Payment is typically provided per visit and depends on factors such as the duration of the trial and the procedures required. The amount of compensation can vary between studies, and participants are informed of the payment details before enrolling, as part of the informed consent process. This ensures that participants are fully aware of the compensation structure before they make their decision to join the trial.

Privacy and confidentiality are top priorities in clinical trials. Personal information and medical data collected from participants are kept secure and confidential throughout the study. Researchers and staff are required to follow strict privacy laws and regulations, such as the Health Insurance Portability and Accountability Act (HIPAA), to protect participant information. Any data shared outside the study, such as in reports or publications, is anonymized to ensure that individual participants cannot be identified. Participants are also informed about how their data will be used and have the right to withdraw their consent at any time without affecting their privacy.

After a clinical trial concludes, the data collected during the study is submitted to the FDA as part of the approval process. This data helps determine whether the treatment should be approved for wider use. Following the trial, participants continue their care with their primary care physician, who will manage any ongoing health needs. Additionally, participants have the option to track the progress of the treatment's FDA approval, staying informed about whether the treatment will become available to the public.

During a clinical trial, participants may receive either the new drug being tested or a placebo, depending on how the study is designed. In some trials, participants are randomly assigned to receive either the active treatment or the placebo, and neither the participant nor the researcher may know which one they are receiving (this is called a "blinded" study). The purpose of including a placebo is to help researchers determine the effectiveness of the new drug by comparing it to a non-active substance. In other studies, participants may receive only the experimental treatment. Regardless of whether a participant receives the drug or the placebo, the goal is to assess the safety and effectiveness of the treatment being studied.

In a clinical trial, a placebo is a substance that looks like the treatment being tested but has no active ingredients. It is often used as a control to compare the effects of the actual drug or treatment being studied. Participants in the trial may be randomly assigned to receive either the placebo or the drug, without knowing which one they are receiving (this is known as a "blinded" study). The purpose of using a placebo is to help researchers determine whether the effects observed are due to the drug itself or if they are simply a result of participants' expectations or other factors. The drug, on the other hand, contains active ingredients that are being tested for their safety and effectiveness in treating a specific condition.

For more information about participating in a clinical study with Legacy MD Research Institute, you can reach out via email at info@legacymdresearchinstitute.com or call (760) 560-0185. Our team is available to answer any questions you may have about the trials, the treatments being tested, and the process of participation. We are here to guide you through the information and help you make an informed decision about joining a clinical study.