What Questions Should Patients Ask Before a Clinical Trial? Informed consent is an important legal practice when clinical trials are being conducted, as they provide participants with the opportunity to learn as much as possible about the trial and what they may encounter during the experience. However, knowing which questions to ask can be an overwhelming thought–there’s a lot to think about when participating in a clinical trial as far as possible risks are concerned. Our goal is to provide you with insight on what questions you should ask before and after agreeing to participate in a clinical trial.
Asking All the Right Questions
Before you begin asking questions to trial managers, first you must ask yourself, why do I want to take part in a clinical trial? Is it to find a possible cure, better management, or prevention for your condition? To volunteer and help progress scientific discovery for others in the future? Is it because you’ve tried other options and believe that a clinical trial could be the answer? It is important to realize what your goals and expectations are when it comes to participating in a clinical trial study, so take this time to really weigh the beneficial outcome to the risks involved. Once you have realized your goals and needs, the trial interview process will provide you with the best knowledge to guide your decision as to whether to take part in a clinical study.
According to the National Institutes of Health, informed consent is a continuous process throughout the entire study. Therefore, as new information arises, the research team is required to make participants aware. Asking questions along the way as new information is presented is always a wise thing to do in order to make the best decisions for yourself concerning your continued participation in a clinical trial.
Once you have found a study that could work in your favor, preparing a list of questions for the interview process is the next step—feeling informed and confident in the clinical trial is the desired outcome, so making thorough preparations ahead of time will assist in achieving these results.
Preparing for the Interview
One way to best prepare is to take extensive notes and even record the meeting if permitted to review again in the future. Bringing a trusted friend or loved one along can also help you take notes and also ask questions that you hadn’t thought of. Be sure to ask any questions you have relating to your specific needs and concerns, as well as consult with your doctor or physician for better insight. With that said, the following list of questions are suggestions we strongly believe will help in this process:
Questions regarding the general clinical trial:
- What purpose does the study serve and why is it taking place?
- What about this study pertains to me?
- Have there been similar studies/treatments conducted? If so, what were the results?
- Is this a study for prevention, screening, diagnostic, treatment, behavioral, or quality of life?
- Why is this study being recommended to me?
- Where can I learn more about this clinical trial and others?
- What led to this specific approach to be studied and tested?
- What makes the researchers believe that this approach might be effective?
- By whom is the study funded? What is their involvement/interest/motivation for doing so?
- Who reviewed and authorized the study?
- Will the clinical trial include the use of a placebo? Will I be receiving actual treatment or will I be taking a placebo? Will this change at all during the study?
- How is the safety of participants and study results being monitored?
- What are the eligibility criteria? If I am not a good fit, are there other options you can recommend?
- What is the anticipated duration of the study taking place?
- If I participate, what are my roles and responsibilities?
- How will I be informed about the results and by whom?
- How long do I have to decide whether or not I want to participate? Can I change my mind after agreeing? Would there be any wait time upon my decision to join or leave?
- Are there any possibilities that I could be removed from the study and for what reason?
- Are there any possibilities that the study could be stopped early? What for?
Questions to ask regarding possible risks and benefits:
- What are the possible short-term benefits? What are the possible long-term benefits?
- What are the short-term risks/side-effects? What are the long-term risks/side-effects?
- Will anyone on my health care team assist me in managing these?
- Are there other options available? If so, what?
- How do the risks versus benefits of this trial contrast with those opinions?
- If the trial is working, how will I be able to tell?
- What are the desired results of the trial?
Questions to ask regarding participation and care:
- What types of therapies, tests, and/or procedures will I receive during the trial?
- How often will they be administered?
- How will they be given/administered to me?
- Will they be painful? If so, for how long?
- Are there risks? Are they similar risks to standard treatment or are they different in any way?
- How do the tests and practices being performed in the study compare with those I would find outside of the trial?
- Will I be able to continue taking my current medications/treatments while participating in the trial?
- Which medications, procedures, or treatments will I need to avoid during or even after the study? For how long?
- Will I be required to provide samples such as tissue, blood, etc.? What is done to the samples, and must I donate these in order to participate?
- Will a biomarker be tested for in the trial?
- Where will my medical care take place?
- Who is in charge of my medical care?
- Who will I need to contact in case of abnormalities during the trial or if I have additional questions?
- How long do I have to decide whether or not to participate?
- When and how will I be informed of the results?
- If my health gets worse, what should I do and what would be expected to happen?
- How often will I be informed about new information regarding the treatment?
- Will my safety be protected?
- Will I continue to see my primary doctor/health care provider while I am participating in the trial?
Questions to ask regarding your personal life:
- How will participating in this study affect my day-to-day life?
- Will I still be allowed to go to work, exercise, and/or eat my normal diet?
- Am I allowed to talk with other study participants?
- Am I allowed to talk about the trial with family and/or friends?
- Will my health information be kept private?
- Who all will know about my participation in the study?
- Will I have access to the results of the trial? How do I access them and when will they be available?
- What will happen if I decide to leave the trial? How can I leave the trial if I decide to?
- Will I be required to stay in a hospital or facility during the clinical trial? If so, how long or often?
- What am I responsible for during the study?
Questions to ask regarding cost and logistical issues:
- Will I have to pay out of pocket for anything in the trial, such as tests or research?
- Will I be getting paid to participate? If so, how much and how often?
- Are there any expenses that I would be required to pay for?
- How much of the expenses are being covered by the clinical trial itself?
- Is there a significant difference in the cost for the clinical trial versus standardized treatment plans?
- Will my health insurance cover me participating in the trial? If so, how much?
- Is insurance a requirement to be able to join this clinical trial?
- Who is equipped to help answer questions from my insurance company/health plan?
- If I am injured, who pays for those costs?
- Will there be any travel or childcare expenses that I need to take into consideration during the trial?
- Where is the trial taking place? Will the study be offered at multiple sites?
- Are there payment management plans if I am required to pay for anything?
- Are there any legal issues involved? Are there liability protections in place?
Questions to ask your doctor/research team regarding the clinical trial:
- What makes the researchers believe that the trial treatment being studied may be more beneficial than treatments in use currently? What may not make it better?
- How will the doctor know if the trial is working?
- Which phase of the trial am I joining? What does that mean?
- Will I have check-ups after the trial with the trial team and/or personal doctor?
- Do you know of other treatment options whether clinical trial or standard practice options?
- What will happen to me with my disease/condition if I do not have treatment?
- Will the clinical trial staff and researchers work alongside my personal doctor while I am participating?
- Will my doctor have any advocacy when it comes to me and the treatments?
- Where can I find the best advocacy groups/resources pertaining to my condition and the clinical trial I am considering participating in?
- Will there be any type of long-term follow-up appointments or care as a part of this study and after the study is completed?
- If I believe I am experiencing long-term side effects after the study, who should I contact and what actions will need to be taken?
- If the treatment successfully works for my condition after the study is over, will I be able to continue to take it? Will I need to keep taking the treatment?
Our goal at Clinical Trial Guide is to help provide you with the knowledge and resources to be able to better navigate the clinical trial world and its processes. While the list of questions above are important to ask the clinical trial researchers and your doctor, your questions shouldn’t be limited to this list alone. Don’t be hesitant to ask anything when it comes to your participation in a clinical trial, as it is directly related to your health and wellbeing. Clinical trial managers are also there to help provide you with the information you need in order to feel completely informed on what there is to expect in the study.
“12 Questions to Ask Before Participating in a Clinical Research Trial.” ObvioHealth, https://www.obviohealth.com/news/12-questions-to-ask-before-participating-in-a-clinical-research-study-trial
Cancer.net Editorial Board. “Questions to Ask About Clinical Trials.” Cancer.Net, 10 Dec. 2020, https://www.cancer.net/research-and-advocacy/clinical-trials/questions-ask-about-clinical-trials
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“Deciding Whether to Be Part of a Clinical Trial2020.” American Cancer Society, 18 Aug. 2020, https://www.cancer.org/treatment/treatments-and-side-effects/clinical-trials/what-you-need-to-know/who-does-clinical-trials.html
“Net Cancer Clinical Trial Treatment Questions To Ask Your Doctor.” Neuroendocrine Cancer Awareness Network, https://www.netcancerawareness.org/clinical-qs/?gclid=Cj0KCQjw9_mDBhCGARIsAN3PaFOZRpp1kADWP7328GncMFt4MD8uvdC7fM161EvXvZbEDRHaz7c-MYcaAitHEALwhttps://_wcB
“The Basics.” National Institutes of Health, U.S. Department of Health and Human Services, 20 Oct. 2017, https://www.nih.gov/health-information/nih-clinical-research-trials-you/basics
“Questions to Ask Your Doctor about Clinical Trials.” Memorial Sloan Kettering Cancer Center, https://www.mskcc.org/cancer-care/clinical-trials/questions-ask-your-doctor
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