• What is a clinical trial?

A clinical trial is a research study that investigates whether a new drug, device, or other treatment is effective in treating a specific condition. Many clinical trials are conducted simultaneously at many different sites in different locations. ​

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• What does it mean to be a participant in a clinical trial?

Participation in a clinical trial can vary from study to study. Potential participants receive detailed information about what is expected of them before they give consent to participate. People who qualify and enroll in a trial at Aura Wellness give consent to receive treatment from our team.

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• What are Aura Wellness's responsibilities if I participate in a trial?

Our ​primary responsibility is to ensure the safety and well-being of study participants. Our team collects and reviews relevant health information throughout each participant's time in a trial. Our medical team works closely with the medical team of the clinical trial sponsor and other clinical research organizations to ensure that participant health is the top priority. Beyond this, Aura Wellness staff work to ensure that clinical trial procedures are carried out with fidelity to the approved clinical trial protocol.

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• What are my responsibilities if I participate in a trial?

Participants in a clinical trial are responsible for attending their study visits and completing study procedures as outlined in the consent document they sign when they enroll in the study. Participants are expected to report on their symptoms honestly and to take their assigned study drug as expected. Study participants are able to withdraw consent to participate in a clinical trial at any time, for any reason.​

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• Who benefits from my participation in a clinical trial?

Clinical trials are frequently sponsored by organizations that want to know whether the treatment they have developed for a particular condition is effective. These organizations may be pharmaceutical or other biotechnology companies. The data that are collected from clinical trial participants are used to determine whether a treatment is effective.​ Additionally, our hope is that participants in the trial benefit from the care they receive and the potential access to novel treatments for the condition being treated.

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• What kind of time commitment is required as a clinical trial participant?

Most of the clinical trials conducted at Aura Wellness involve three stages: 1) the screening period, 2) the treatment period, and 3) the follow-up period.​ The time commitment varies from study to study, but typically lasts between three and four months. Some trials are shorter and some much longer, and you will get specific information about the time required to participate prior to giving your consent to participate.

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• Is it possible to receive a placebo as a clinical trial participant?

Many clinical trials are "placebo-controlled", meaning that participants can either receive the drug being studied or an inactive placebo as treatment. In these trials, typically neither the participant nor the Aura Wellness team will be aware of which treatment is being received. In all cases, participants will be treated with the highest standards of care during their study visits.​

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• What are the benefits of being in a clinical trial?

All participants in a clinical trial will have their health monitored by our licensed clinical team for the duration of their participation. For the majority of trials, participants receive a monetary stipend for completing study visits and procedures. Participants may also see improvements in their symptoms as a result of the treatment they are given. ​

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• What risks are associated with being a clinical trial participant?

Clinical trials often use investigational treatments, which are not yet fully understood in terms of their effects. Some of these treatments may be in their earlier stages of investigation, and less well-understood, while others may be in later stages of development, and have some well-established effects. In all cases, there is always a possibility of having some negative health outcomes as a result of clinical trial participation. Typically, these health outcomes are very temporary and resolve quickly. Treatment side effects that are known to occur are always disclosed to trial participants. All participants are encouraged to be thoughtful about their participation in a clinical trial, to consult with their health provider, and to ask questions to make an informed decision about their participation.​

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