WHAT TO ASK

Before you agree to participate in a clinical trial, it’s vital to understand exactly what you’re signing up for. “It can be a shared discussion between the patient and their treating physician, who may be the one to recommend the study,” says Dr. Sara Keck of Providence Medical Group in Santa Rosa, which conducts numerous clinical trials, mostly with cancer patients. “Often, patients have come to a point in their care where there are no longer any conventional treatment options, so they start looking for a clinical trial.” When speaking with your doctor about participating in a trial, consider taking a family member or friend along for support and for help in asking questions or recording answers. Plan ahead what to ask, but don’t hesitate to ask any new questions you think of while you’re there. Write down your questions in advance to make sure you remember to ask them all, and take careful notes so you can review the conversation again later. Ask about recording what’s said (even if you write down answers), or record the conversation yourself; most smartphones have a built-in recording app. Here’s a list of questions that can help you make an informed decision:

THE STUDY

• How long will the study last? When does it start and end? • What is the purpose of the study? • What “phase” is this trial? • Why do researchers think the approach may be e ective? Why might it not be e ective? Has it been tested before? • Who will fund the study? • Who has reviewed and approved the study? • How are study results and safety of participants being checked? • What will my responsibilities be if I participate? • Who will pay for my participation?

POSSIBLE RISKS AND BENEFITS

• What are my possible short-term benefi ts? • What are my possible long-term benefi ts? • What are my short-term risks, such as side e ects? • What are my possible long-term risks? • What other options do people with my disease have? • How do the possible risks and benefi ts of this trial compare with those options?

PARTICIPATION AND CARE

• What kinds of therapies, procedures, and/ or tests will I have during the trial? • How will the medicine, medical device, or test be given to me? • Will they hurt, and if so, for how long? • Can I drop out of the trial if I become too uncomfortable? • How will it be determined which interventions I receive (for example, by chance)? • Will I be able to take my regular medications while participating in the clinical trial? • Where will I have my medical care? • Who will be in charge of my care? • Who will know which intervention I receive during the trial? Will I know? Will members of the research team know? • How often will I have to visit the hospital or clinic? Will hospitalization be required? • If I benefi t from the intervention, will I be allowed to continue receiving it after the trial ends?

PERSONAL ISSUES

• How could being in this study a ect my daily life? • Can I talk to other people in the study? • Will I be reimbursed for other expenses? • Will results of the study be provided to me? • What are my options if I am injured during the study? • What type of long-term follow-up care is part of this trial? • How is my privacy protected throughout the study?

COST ISSUES

• Will I have to pay for any part of the trial, such as tests or the study drug? If so, what will the charges likely be? • Will there be any travel or child care costs that I need to consider while I am in the trial? • What is my health insurance likely to cover? Will the drug company pay my insurance co-pay? • What if the investigational drug or device makes my illness worse, or causes another medical issue in me? Will my insurance cover it? Or does the sponsor company? • Does the sponsor company or other insurance o er coverage for my family in the event that I die in the trial? Will my life insurance still cover me? • Who can help answer any questions from my insurance company or health plan?

Sources: Meridian Clinical Research (www.mcrmed. com); National Institute for Mental Health (www.nimh.nih.gov); ClinicalTrials.gov