Questions to ask about trials

We asked the more than 1,500 patients in COLONTOWN’s clinical trials neighborhoods what questions they would ask about a clinical trial they are researching. Here are some of their suggestions.

If you have any questions about a trial, reach out to the Trial Coordinator, who is there to answer your questions! You can also reach out to your oncologist and see if they can offer you any advice or insight.

Not all of these questions will be relevant for each situation. You can print this page out, circle the ones you’d like to get answered, and take notes!

The treatment or intervention itself, and why it might be an option for you:

• What will the treatment that I will be receiving consist of?
• Why is this a good trial for me? Is there something in my specific tumor genetics that aligns with this treatment?
• What pre-screening additional testing will be required prior to enrolling?
• Are there other tests/updates we can get on my current status? CtDNA/Liquid Biopsy? HER2/3 status?
• What are the chances I will get the experimental treatment?
• Will I know which arm I’m on? If so, when will I find out?
• What are the possible risks, side effects, and benefits of the study?
• How will I know if the treatment is working?
• What criteria will be used to determine trial success or failure?
• Which criteria will be used to determine whether or not I stay on the trial? What is the frequency of that assessment?
• How will you protect my health while I am in the study?
• What happens if my health gets worse during the study?
• Will I be able to get palliative local treatments to non-target lesions (the ones not measured in the trial)? 
• Why is this trial better than other options?
• Are there trials at other institutions I should consider?

Logistics of being on the trial:

• How often will I have scans? What about other monitoring requirements?
• How will the study affect my everyday life? Will I need to modify my daily activities in any way?
• How long will the clinical trial last?
• Where will the study take place?
• Will I have to stay in the hospital?
• How often will I need to go to the study site?
• Will you provide a way for me to get to the study site if I need it?
• Will being in the study cost me anything? If so, will I be reimbursed? 
• Will my insurance cover my costs? Will my insurance consider this in- or out-of-network care? 
• Will the study provide free scans and monitoring?
• Are any biopsies or procedures optional?
• Can I take my regular medicines/vitamins/supplements while in the trial?
• Who will be in charge of my care while I am in the study? Will I be able to see my own doctor?
• What other activities will be expected of me during the trial (like keeping a diary of side effects)? What other information will you need from me?
• How often will I receive updates on the trial?
• Will I get additional testing results (like CtDNA) in real time?

After the trial, or your participation in it, has ended:

• What happens if I achieve positive outcomes after the study is completed — will I still receive the therapy that is tracked during the study?
• Will you follow up on my health after the end of the study?
• Will I have access to biopsy tissue after the study?
• Will you tell me the results of the study?
• If I withdraw, will this affect my eligibility for other trial or treatment options?

Other considerations:

• Many patients and their oncologists say that they should exhaust “standard of care” treatments before moving on to clinical trials. Is that a good strategy?
• Will participating in one trial will exclude me from joining a different one later on?
• Who do I call if I have more questions?
• How will you keep my doctor informed about my participation in the trial?
• What steps will be taken to ensure my privacy?
• Is there any preliminary data available? What do prior studies of this treatment show?
• If it is a phase I trial, have any of the drugs/methods been tested separately in previous trials? Is there any data on the safety? (Sometimes, trials are phase I because the combination is new, but each drug is known)
• If it is a phase I/Ib or phase I/II trial, has dose escalation been completed?
• How long has the trial been going on, and what response have participants had to date?
• If only a small number of patients are responding, what is special about those patients? Why do you think I could be a responder?

For immunotherapy trials:

• For those with unresectable (incurable) stage IV CRC: when should I look to enroll in an immuno-based trial?
• For MSS patients with low TMB, no PDL-1 expression, low TILs, no Lynch mutations: Why do you think this trial would work for me?