Key Questions to Ask When Looking for a Clinical Trial

November 29, 2024

CLINICAL TRIALS

SUMMARY

Participating in a clinical trial can be an exciting opportunity to explore new treatments, innovative drugs, or medical devices that could improve outcomes for certain diseases. However, it’s a big decision that requires careful consideration. Whether you’re considering enrolling in a clinical research study for cancer treatment, new combinations of existing drugs, or even exploring new ways of managing a chronic condition, it’s essential to understand the details of the trial.

By PatLynk

Key Questions to Ask When Looking for a Clinical Trial

Here are the key questions you should ask yourself and the research team before participating in a clinical trial to ensure you're well-informed and comfortable with the decision.


1. What is the Purpose of the Trial?


First and foremost, you should understand the purpose of the clinical trial. Ask the research team about the specific goals of the study, such as whether it aims to test the efficacy of a new drug, evaluate medical devices, or investigate new approaches for managing cancer or other diseases. Knowing this will help you determine whether the trial aligns with your health needs and goals. Trials can be interventional or observational studies, which affects how the treatment is applied and studied.


Key Questions to Ask:

  • What is the main objective of this clinical trial?
  • Is this an interventional trial (a study where participants receive a specific treatment or intervention to evaluate its effects) or an observational study (a study where participants are observed, and researchers collect data without providing treatment)?
  • Will this trial involve new drugs, biological products, or medical devices?
  • Is this study designed to explore new combinations of existing treatments or test a new drug or experimental treatment?
  • For treatment trials, has it been tested on human subjects already? In my country or in another ones? On small group or larger group of people? For what results?

2. What Are the Eligibility Criteria?


Before you consider enrolling in a clinical trial, it’s important to check if you meet the eligibility criteria. Clinical trials are often designed for patients with a specific disease or condition, and the research team will likely require you to meet certain health parameters to participate.


Key Questions to Ask:

  • What are the eligibility requirements for this trial?
  • Is my specific condition, such as cancer or another certain disease, covered by this study?
  • Are there age, gender, or other medical factors that could affect my eligibility?
  • Are there any restrictions based on previous treatment or existing treatments I have received?

For more information on eligibility, please refer to our article on "Am I Eligible for A Clinical Trial?"


3. What Are the Potential Benefits?


While clinical trials often offer the chance to access new treatments or experimental drugs not yet available to the general public, you must understand the potential benefits. For example, you could receive standard treatment alongside an experimental option or gain access to the latest new drugs and therapies.


Key Questions to Ask:

  • What are the potential benefits (the positive outcomes that might arise from participation) of participating in this trial?
  • Will I have access to new treatments that might not be available outside the trial?
  • How might the trial help future patients or contribute to medical advancements?
  • Could this trial offer new ways (innovative methods) of treating my condition, or offer access to new combinations of existing therapies?

4. What Are the Risks Involved?


Every medical treatment, including participation in clinical studies, carries risks. Before committing, ensure you’re fully aware of both the known and potential risks, including side effects of new drugs or the chance of being placed in a control group. It's important to discuss how these risks might impact your health, particularly when participating in a placebo-controlled trial, where you may receive a placebo (an inactive substance) instead of an active treatment.


Key Questions to Ask:

  • What are the potential risks (possible negative effects or side effects) of participating in this trial?
  • Are there any side effects (undesired effects that can occur from the treatment) or adverse reactions (severe, negative reactions) related to the experimental treatment?
  • Is there a possibility of receiving a placebo (an inactive substance used as a control in testing) instead of the actual treatment?
  • If I am in a control group (a group of participants receiving either no treatment or a standard treatment for comparison), how will that affect my treatment and overall care?
  • If this trial involves masking or blinding (when the participant and/or research team does not know which treatment is being given to avoid bias), how will it affect my participation?

5. What is the Trial Design?


Understanding the study design is crucial to knowing what your experience will be like as a participant. Clinical trials may use different phases, such as phase 1 trials (testing safety) or phase 3 trials (confirming effectiveness), and could involve either a treatment group or a control group. Trials may also incorporate randomization (a process where participants are assigned randomly to different groups to eliminate bias), where participants are randomly assigned to different groups.


Key Questions to Ask:

  • What phase is this clinical trial in (Phase 1 trials typically test safety, while Phase 3 trials confirm effectiveness and compare treatments.)?
  • Is the trial randomized (when participants are assigned to treatment or control groups randomly to reduce bias) or non-randomized?
  • Will I be part of the treatment group (the group receiving the experimental treatment) or the control group (the group that receives the standard treatment or placebo for comparison)?
  • Is the study blinded or masked (when neither the participants nor the researchers know who is receiving which treatment to avoid bias)? If so, will I know what treatment I'm receiving?
  • How is the trial designed to test the new treatment or drug?

For more information on trial design, please refer to our article on "How Clinical Trials Work".


6. What Will the Informed Consent Process Be Like?


The informed consent process is a key aspect of clinical research to ensure that you understand the trial's details before enrolling. You’ll be provided with documentation outlining the study’s purpose, procedures, risks, and benefits.


Key Questions to Ask:

  • Can I review the informed consent document before making my decision?
  • Will I be given adequate time to ask questions and discuss the trial with my family and healthcare team?
  • How will my privacy be protected throughout the study?
  • Will the informed consent form explain whether I will receive interventional treatment (active treatment) or be part of an observational study (where no treatment is provided)?

7. What is the Time Commitment?


Participating in a clinical trial can require a significant time commitment, with multiple visits, tests, or procedures. It’s important to know how often you’ll need to participate and what resources (travel, time off work, etc.) may be needed to fulfill the requirements of the research study.


Key Questions to Ask:

  • What is the expected duration of the trial?
  • How often will I need to visit the clinic or participate in follow-up appointments?
  • Will I be required to undergo additional tests or treatments during the trial?
  • Will there be periods of observation, or will the trial require active treatment?

8. Are There Financial Costs or Compensation?


Some clinical trials may offer compensation for your time, travel, and participation. Others may be covered by insurance or the trial sponsor, but it’s essential to clarify these details before committing.


Key Questions to Ask:

  • Will my participation in the trial be covered by my insurance or the trial sponsor?
  • Are there any costs I will need to pay out of pocket, such as for transportation or medications?
  • Will I receive compensation for my time and travel?
  • Will the sponsor (the entity funding the trial) or research team provide assistance for any additional costs incurred during the trial?

For more information on financial compensation, please refer to our article on "Paid Clinical Trials" Clinical Trials".

9. How Will My Progress Be Monitored?


It’s important to understand how your health and progress will be monitored during the study. Ask the research team about the types of assessments, tests, and evaluations they will conduct to ensure the safety and effectiveness of the treatment.


Key Questions to Ask:

  • How will my health be monitored during the trial?
  • Will I receive regular check-ups and lab tests?
  • Will I be asked to track certain symptoms or outcomes as part of the study?

10. Can I Withdraw From the Trial at Any Time?


Even after enrolling, you have the right to withdraw from a clinical trial at any time. However, it’s crucial to understand the implications of withdrawal, especially if you’re participating in a trial involving experimental treatments.


Key Questions to Ask:

  • Can I withdraw from the trial if I no longer wish to participate?
  • Are there any consequences to withdrawing early, particularly in interventional trials where treatment might be interrupted?
  • How will my withdrawal affect my ongoing care and treatment?
  • If I withdraw, can I continue with standard treatment options?

Food for Thoughts


Enrolling in a clinical trial is a big decision that requires thorough research and understanding. By asking the right questions to both yourself and the research team, you can make an informed choice about whether participating in a research study is the right path for you. Whether you're interested in new treatments, exploring new drugs, or contributing to the advancement of clinical research, being fully informed ensures your safety and well-being while participating in the trial.

Ultimately, clinical trials provide an opportunity to contribute to the future of medicine and could lead to the discovery of new ways to treat diseases, benefiting both current and future patients.