The decision to enroll in a clinical trial is highly personal. Many individuals take part in a clinical trial because their condition is not responding well to standard treatment so they are hopeful that the therapy being investigated will provide more relief or better quality of life. Other people participate in clinical trials to contribute to the existing body of medical knowledge and to help doctors find new ways to treat patients. Factors influencing the decision to participate can do with one’s overall health status, prognosis, lifestyle risk, genetics, desire to be altruistic, and/or previous disease experience.

Generally speaking, anyone who is a match to a trial’s requirements, called eligibility criteria, can seek to participate in a trial. Typically a trial will look for individuals with the illness that the intervention is being evaluated against. There are also trial opportunities for ‘healthy volunteers’ that are interested in helping further understanding of vaccines and other mechanisms applicable to generally healthy individuals.

Eligibility criteria are the factors that a potential trial participants must screen against. Inclusion criteria are attributes that a participant must have or fit in order to participate. These commonly include disease related items (a particular condition, a specific cancer type or stage, a genetic factor), age (within a stated age range), weight considerations, medication status, certain bloodwork values, and more. Exclusion criteria are the factors that will prevent a participant from being able to enroll. These are items that an individual must not have in medical history and may include other medical conditions, surgeries, medications, pregnancy status and additional attributes.

A process called informed consent is used to educate potential participants with the details about a trial of interest. The information provided through informed consent intends to protect potential enrollees by laying out any potential risk as well as options for discontinuing participation. Informed consent seeks to help individuals decide whether or not to participate given the trial protocol, possible risks, alternate choices and more. This process, which is reviewed by an IRB, also reinforces that a participant may withdraw from a trial at any time, for any reason.

Participants must be a good fit for a trial based on the protocol’s eligibility criteria. It is very important however that all kinds of people are represented in clinical research efforts. This is because certain conditions and medications may affect people differently based on their age, sex, race/ethnicity, and their genes. Having a diverse trial enrolled population helps ensure that should the studied intervention lead to an approval, that it is appropriate to the general population so that everyone can benefit from medical advances.

No, there is no cost to participate in a clinical trial, nor is health insurance required. However, you may need to pay for travel costs such as gas to attend any in-person visits at a study site location. You may also need to pay for childcare and should also consider any lost wages if study visit timing occurs during your work hours.

Some clinical trials may provide payment for participation, while others may provide compensation for associated time and travel costs. Be sure to ask for specifics on compensation prior to agreeing to participate in any trial.

The length of a clinical trial and how much time it will require on the part of a participant varies depending on what is being studied. Some studies last weeks, others last years. Clinical research personnel will explain the specifics of the study timeline and required visits to help with your decision-making process.

Yes, participants should still maintain their existing clinician relationships and stay current on preventive measures. This is because the scope of care provided through a trial experience is limited to the illness being evaluated. A clinical trial is not meant to provide a complete healthcare experience. It is a good idea for participants to let their primary physician(s) know about their trial participation to reduce any confusion around medication status or other changes relevant to the patient’s overall medical picture.

Assignment is typically done via a process called randomization. This means that assignment to treatment or placebo, if part of a trial, is done by chance, as opposed to deliberately, in order to avoid bias (subconscious preferential treatment). A trial that is blinded means that participants and possibly even the trial team will not have knowledge of which participants are receiving which specific treatment. The effects of each intervention are evaluated over the course of the trial; if one is determined to provide more benefit, all participants will be offered that specific treatment.