Clinical trials may be something you’re familiar with, but do you know the depth of what they can entail? Before participating in potentially groundbreaking research, it’s crucial to know the structure of the clinical trial and what’s expected of you as a participant. When you’re well-informed about clinical trials, you can feel more confident about your involvement in medical research.
Here are 15 questions to ask about clinical trials before participating:
Why you might need a clinical trial
Clinical trials are designed to test methods of treatment, diagnosis, or monitoring for specific medical conditions. These trials can yield valuable data that healthcare professionals can use to treat other individuals with the disease. By participating in a clinical trial, you can access medical treatments that aren’t yet publicly available but could be more effective than current standard treatments. This access is critical for people living with rare conditions or at a late stage of disease.
You May Also Like
As a Black participant in a clinical trial, you are also providing critical information that can help healthcare professionals tailor treatments to improve outcomes for a group that’s often underrepresented in research and faces poorer outcomes for several diseases.
15 clinical trials questions to ask your doctor
Below are 15 questions to ask about clinical trials before participating in medical research.
1. What phase is the clinical trial in?
Clinical trials have four phases. These include:
You May Also Like
- Phase 1: Researchers determine the safety, dosage, and side effects of a new treatment among a small group of patients.
- Phase 2: The treatment is tested in a larger patient group, with researchers continuing to assess safety while evaluating effectiveness.
- Phase 3: Researchers compare the new treatments to standard therapies. Some patients will receive the new treatment, while others will receive the commonly used treatment. This phase can involve hundreds or thousands of patients across multiple locations.
- Phase 4: Researchers assess the long-term safety of the new drug or treatment. This phase of the clinical trial typically begins once the new treatment is approved for standard use and marketed to the public.
2. How do you think this trial will benefit me?
The expected outcome of clinical trials can vary. Even if it’s designed around your specific medical condition, it doesn’t necessarily mean that the research is focused on a treatment that will help you, specifically.
3. How will my daily routine change?
Clinical trials usually have set schedules for administering medications, conducting follow-up tests, and monitoring. You’ll likely need to adjust your routine to ensure you’re on time for appointments and have enough time for everything required.
RELATED: 6 Common Questions We Get About Cancer Clinical Trials, Answered
4. Will there be side effects of a clinical trial?
This can be tricky, depending on the clinical trial phase and the medication being used. The researchers may not have a complete list of potential side effects. However, there should be a process in place for you to report any changes in your health.
5. Can I continue any of my current medications?
It depends. Taking certain medications may disqualify you from a clinical trial because of the risk of a potential drug interaction.
6. Can I pick which group I go into?
You may want to be in the group that receives the new drug, but that’s not always your decision to make. Some clinical trials are randomized, meaning participants are assigned at random to receive the drug. Additionally, some researchers opt for a double-blind trial so that even the doctors don’t know what treatment you’re receiving. Additionally, if the treatment is proven to be effective, all participants will be eligible to receive it.
7. Will I still see you or any of my regular doctors?
While you’ll be seen regularly by the doctors in the clinical trial, it’s understandable that you’ll want to keep seeing your regular doctor. They should be able to tell you how that can happen and what information you might be able to share about the trial. In most cases, you can still receive your regular medical care outside of the clinical trial.
8. Will I know if the clinical trial treatment is working?
Medications may not work the same way for everyone, or may not take effect on the same timeline. Your doctor may still be able to give you an idea of what to expect or what to ask the medical team that’s involved with the trial.
9. Will I be able to work during a clinical trial?
Clinical trials may affect your work schedule, depending on their requirements and the potential side effects of the medications being used. Your doctor may be able to guide you on whether or not you’ll need to take time off from work.
10. Will I need to spend any time in the hospital?
Possibly. Clinical trial treatments must be administered or monitored in the hospital, so it’s important to plan accordingly for work, childcare, or other responsibilities.
11. Will anyone have access to my information?
Generally, your personal health information will be confidential. The researchers and certain health agencies may have access to it, but you can ask your doctor about the specifics of this trial to confirm.
12. How can I afford a clinical trial?
Typically, clinical trials are very cost-effective, as the sponsor, such as a pharmaceutical company or research institution, covers study-related costs, including the treatment itself, specialized scans, and tests. Any routine care is often covered by insurance or Medicare, which is mandated by U.S. law. You can always ask your doctor whether the clinical research team can provide a detailed written budget and reimbursement for travel, lodging, childcare, or other expenses you may incur during your involvement in the trial.
13. What happens when the trial is over?
This may vary by trial, but collecting information and planning the next step will be involved. You’ll likely want to know if you’ll still have access to the treatment if it’s been working for you. If not, find out how your treatment will proceed.
14. What happens if the trial ends abruptly?
Occasionally, researchers end a trial prematurely. Ask your doctor what you should do about your treatment if that happens, and if you’ll be considered for future trials.
15. Can I get access to the trial results?
You might be interested in the overall results of a clinical trial and what it might mean for you. Ask your doctor if that’s possible and how much information you’ll get.
