Do you have a clinical trial in mind that you hope to join? If so, you are about to take on a vital journey that might serve both yourself and future patients. Before you get started, it’s really important to prepare some recommended questions to ask during your screening appointment. This guide will help you navigate the process with confidence. You do not have to ask every question however we though we would give you a compressive list to make it easier for you…This may also stimulate some new questions, we would love to here those if you are happy to share.
Understanding the Purpose and Design of the Trial
When you go to your screening, first get a good sense of what the clinical trial is about. Here are some questions to consider asking:
- What is the primary purpose of this clinical trial?
- What is the duration of the trial and the overall study?
- What tests and treatments will I receive for study purposes?
- How will the research team know if the treatment is working?
- What exactly is the study design and can you tell us in lay terms?
- Will I be guaranteed to receive the study drug or could I receive a placebo?
Having a handle on these facts will assist you in seeing the larger picture of the study you are potentially entering.
Assessing Risks and Benefits
All clinical trials carry potential risks and benefits. It’s important to comprehend these fully before making your call. Ask:
- What are the potential side effects or risks associated with the new treatment?
- What might be the immediate and long-term advantages?
- How does the potential risk/benefit of this trial compare to what would be expected with standard treatment options?
- What safety measures are in place to protect the participants during the study?
The research team should be able to clearly explain these points to you without using overly technical medical jargon.
Clarifying the Rules of the Game – Participation Requirements
Clinical trials often take a lot of time to participate in. Be sure to understand what is expected of you:
- Will I have to go to a hospital or clinic often?
- Will I have to be hospitalised at some point during the trial? If so, for how long?
- How much do I need to travel to engage?
- What must I do to qualify to participate in this trial?
These requirements will help you decide if the trial is manageable with your day-to-day life.
Getting Treatment Details
You need to have a clear idea of the treatment you’ll be getting:
- What is the treatment exactly and how will it be given?
- Will there be a chance that I will be in the placebo group?
- What is a control group, and does this trial have one?
- Will I be able to continue taking my regular medications while in the trial?
These questions will give you a sense of what to expect during the trial’s treatment phase.
Costs and Compensation
Paying you for participation in clinical trials is a key consideration. Don’t hesitate to ask:
- What expenses will be covered for participating?
- What costs will my health insurance pay for if there is an issue during the trial?
- Will you compensate my travel expenses?
- Will I be compensated for my time in this trial?
Having all the facts about the cost helps identify if a trial is worth pursuing.
Keep In Mind Your Rights and Protections
You have certain rights as a potential participant that are protected by law. Make sure to ask:
- What will you do to ensure my health information is kept private?
- What if I want to terminate the trial before the end of the term?
- If I have questions or concerns during and after the trial, who can I reach out to?
- What is the informed consent process?
Knowing your rights will also help you feel more at ease with your participation.
Effects on Daily Life and Subsequent Care
Finally, think about how the trial could impact your daily life and what will happen after it concludes:
- Will I have any restrictions on what I can do while in the trial?
- If you are in the trial and have been assigned to get the intervention, after the trial ends will I have check-ups as part of getting follow-up care?
- How will I find out what happened in the trial?
- Who will manage my care during the trial, and can I continue to see my regular doctor?
These questions should give you a good overall sense of what will be involved if you decide to participate in the clinical trial. There are no silly questions when it comes to your health and well-being! The research team should be happy to answer all your questions about their research team.
The practice of clinical trials is an essential part of medical research and treatment development. By asking these questions, you’re not only protecting yourself but are also now helping ensure the quality and ethical nature of clinical research.
It’s OK to take notes during your screening appointment, and to take a friend or family member for support. Your involvement in this process is crucial, not only for your own decision-making but also for the success of the clinical trial.