Yes, clinical trials can often provide early access to a new intervention that is generally not available outside of the study. For example, trial participants may be the first to benefit from a new treatment, or gain information about their health status and health risks they wouldn’t otherwise have. 

In early clinical studies, the safety, side effects and effectiveness of the intervention are still being ascertained. Despite all the research leading up to the trial (including earlier phases), there is always a chance that therapy will not work, could cause certain side effects, or ultimately not be approved by the FDA. In randomized studies, patients cannot choose which group they are assigned to; in blinded studies, patients do not know which intervention they are receiving (or, in some cases, whether they are receiving a placebo). 

While being in a trial cannot always guarantee immediate effects, the advances made in medicine through this process will benefit your future health and others around the world.

Clinical trials are designed with strict safety measures to protect participants. Many years, even decades, of pre-clinical benchwork and animal testing are conducted before an intervention ever reaches a patient. The research field follows strict processes and rigorous protocols reviewed by regulatory agencies like the FDA, ethics committees, experts in the field, and external data safety monitoring boards (who do not have a financial interest in the study) to ensure risks are minimized. 

Participants are monitored closely, and trials can be stopped if unexpected safety concerns arise. Before joining, participants receive detailed information about potential risks and benefits through the informed consent process.

Anyone can participate in a trial if they have the condition the therapy, vaccine, diagnostic, or device is intended to treat. Every trial has a strict, predetermined, and specific set of inclusion and exclusion criteria which may include aspects of medical history, demographics, medications, physical exam findings, labs, or imaging.  In order to participate in a trial you must satisfy all of these criteria.

Being in a clinical trial is an elective choice. Just like when joining, you are free to leave whenever you want. If you choose to leave a trial, the clinical trial team may want to know the reason for leaving and whether it has to do with a side effect, new medical issue, life event, or other reason so they can safely monitor, document, and report any information which may impact others. The team may discuss the option to remain in the study for safety monitoring purposes even if you choose to no longer receive the intervention.

No. All visits and procedures that are directly related to the study are covered by the trial. No out of pocket costs or insurance is billed for the trial. However, any medical needs that are determined to not be related to the study would require standard of care payments.

Moreover, you may be reimbursed for time & effort, travel, or mileage depending on the study.