There are several key questions that a participant will want answered before enrolling in a clinical trial. Many are listed here, but patients should feel free to ask study coordinators any additional questions they may have so their concerns are well addressed before the trial starts. It is important for a study participant to learn as much as possible prior to entering a trial, and to thoroughly discuss the study with a doctor and with the study team.
Questions About the Trial:
Clinical trials vary greatly. Each trial is designed in a way that best allows its researchers to determine the particular goals or endpoints under study for an experimental therapy, such as a new drug in development. Since clinical trial designs are highly customized, it is important to ask the right questions in order to determine if the trial is a good fit. Each patient, too, has individual health needs and considerations. Here are examples of questions you might ask a study team:
- How long will the trial last?
- What are the advantages of participating in this trial?
- What are the possible disadvantages of participation in this clinical trial?
- When do I need to decide whether I want to participate in the trial?
- What are the eligibility criteria?
- If I am not eligible, can you recommend other options?
- In addition to the experimental treatment, what other treatments are offered in the trial?
- What are the chances of my being in a comparator group, and receiving a placebo or other treatment?
- How frequent are the study visits?
- How long do the study visits last?
- Where do study visits take place?
- What tests are performed during study visits?
- Can I go about my daily life while I participate in this trial?
- Will I need to enter the hospital during the clinical trial?
- Will I need to pay for any part of participation in the trial?
- If so, will these costs be reimbursed by my insurance?
- Will I receive assistance in gaining insurance reimbursement if I need it?
- Will I receive any payment for participating in this trial, or for associated costs like travel?
- Can I take my current medications or treatments while participating in the trial?
- Are there treatments that I must discontinue or avoid while I am in the trial?
- Will my trial information be available to me and my doctor after the trial is over?
- How can I find out the results of the trial?
- When will the trial results be available?
- Who will provide my healthcare during the trial?
- Who will provide my medical care after the trial is over?
- What contact information do I need should I experience side effects or have other concerns?
- Will biospecimens (blood, urine, etc) be collected during the trial?
- How many people are participating in this trial?
- Will I know who else is participating?
- Will I be allowed to talk to study participants?
- Will counseling be available during the trial?
- If I decide to leave the trial before the study is over, what is the procedure?
Questions About the Treatment:
While the trial itself will have many variables that patients need to consider, the treatment being given is arguably the most important. It is crucial that patients ask the right questions about an experimental therapy to determine how well-suited it is to the patient’s health needs. Here are some questions relating to the treatment itself:
- What is the treatment?
- Why does the team believe that this treatment will work?
- What might be the long-term benefits of this treatment?
- How do you believe this treatment might compare to currently available treatments?
- Have there been other clinical trials of this treatment or other types of studies?
- What were the results of other studies of this treatment?
- What are the possible side effects of this treatment?
- How do those side effects compare to what is known about currently available treatments?
- Will the treatment be available after the study ends?
- If I am placed in the comparator or control group, will the treatment be available to me after the study is over?
Participants should feel free to ask these and any other questions, and should also thoroughly review the Informed Consent Document associated with the study. The Informed Consent Document details the study and the participant’s role and rights. Participants may find they have additional questions after reading the consent document.