If you’re looking at weight-loss clinical trials in the UK, then you’re probably juggling two things at once: hope that this could be a structured next step, and a very normal “what am I actually signing up to?” feeling.
This article is here to help with that.
A clinical trial team should expect your questions. Asking them is part of making an informed decision. The UK Health Research Authority explains how prospective participants should be informed before consent is sought.
Start with the two things that matter the most
It is best that the information is in a format you can read at your own pace, such as an information sheet for participants, and that you can ask questions about anything that concerns you before giving your consent. If you feel like you’re being rushed or dismissed, that’s useful information to know, too!
Important from the start: the research is voluntary, and you can withdraw from the study later if you change your mind.
A “shortlist” of the most important questions to ask
If you are looking for a brief and useful tool to help you get started, the following questions are vital in measuring your level of confidence in the trial:
- What are the goals of the study, and why are they significant?
- What will I have to do, and how often?
- How long will the trial last, and what does a typical month look like?
- Is there a control group, including a placebo, and what level of support do I have access to?
- What have been the most common side effects thus far, and in what situations should I contact the study team?
- If I am not feeling well or have concerns about the study, who do I contact and how quickly can I expect a response?
- If I need to change an appointment, what should I do, and are there any mandatory visits I need to make?
- What happens when the trial is over? Is there a follow-up, results and next steps?
Great, now let’s go into more detail and in a way that’s actually useful and practical.
Questions about the study itself
These questions help you evaluate whether the study is legitimate, organised, and right for you.
How does the study design work and why?
If the researchers throw around terms like “randomisation” and “blinding,” ask them to explain these in the context of the study.
What’s a “good outcome” in the study?
While weight loss is certainly an outcome, many obesity clinical trials also measure other health factors.
What phase is the study in? What’s known so far?
Is the treatment already in use in the healthcare system? Is the study evaluating the treatment in groups?
Who’s sponsoring the study?
In the UK, there are clear rules about who’s in charge of and responsible for clinical trials.
Questions about the day-to-day experience in the study
Now we get into the nitty-gritty of “joining the clinical trial” as a routine-based decision.
How many times will I need to come in? What’s the typical schedule?
Can you ask for a simple overview of what the process would entail, such as screening, baseline and follow-ups?
How long does the visit need to last?
Having a general idea of the length of the visit might be helpful.
What kind of procedures will I have to undergo?
This might include measurements, blood pressure checks, blood tests, ECGs, questionnaires, or diary entries, among others. The specific tests will depend on the research, and you might ask for further information regarding them.
Will I have to undergo any kind of remote tests?
Some tests might require telephone calls or a combination of telephone calls and online questionnaires, among others.
Questions regarding support, side effects and safety
There is considerable hesitation among potential research participants. While some of the hesitation is related to the research, some hesitations relate to the “what ifs” and the possibility of becoming ill as a participant.
If a participant is not feeling well between scheduled research visits, what is the process to deal with this?
It is wise to ask about the process for contacting the research team to get advice if you are not feeling well.
How do I deal with potential side effects?
This could include additional tests, medication or dosage adjustments, and a doctor’s review, among other things.
What helps to keep me safe, and when would I stop the research due to safety concerns?
Good studies will be very open about safety and the specific safety measures in place.
It is worth noting that the pages we have set up for our research trials at Panthera contain information regarding the research that is being carried out as well as the safety measures that have been implemented. These pages are designed to answer any queries you may have about the research, what you can expect from it, and how it works. You may find that your queries are answered through the information that we have provided.
Questions about work and scheduling
If you’re a busy person, such as a full-time worker, you’ll find answers to your questions about how the research works and how much time the research will take in the following questions. For general research trials, patient information often discusses the time commitment and how to plan for the research.
Is the schedule fixed, flexible, or a combination of both?
Some data collection might have specific timing requirements.
What happens if I need to change the schedule?
This is a good time to ask how much notice is required for any changes.
How much notice will I receive for my appointments?
This is useful for planning annual leave.
Will I have any work outside the clinic?
For example: questionnaires, food diaries, exercise logs.
Questions about what happens at the end
People often join a trial thinking the “end” is a clean finish line. Sometimes it is, but often there’s a planned follow-up.
What happens at the end of the study?
This might include final data collection, final questionnaires, or follow-up data.
Will I receive my results or the final results of the study?
Similarly, ask what you’ll receive, when you’ll receive it, and how you’ll receive it.
What options will I have at the end of the study?
This might include what happens at the end of the study.
Questions about your data, confidentiality, and who sees what
This is the question you might least like to ask, but it’s a massive confidence booster when you get a clear answer!
What personal data is collected, and why do I need it?
Research should collect only the minimum data required.
Who has access to my data: the clinic, the sponsor, or others?
And will my data be shared with others?
Will my data be used in future studies?
In some cases, data may be kept in a safe place for future studies, usually under very strict rules, and you should be told what applies in your case.
What happens if I withdraw from a study, and what about the data that’s already been collected?
Again, this varies, but it should all be clearly explained.
Thinking of joining a study?
One way of ensuring that the study is in alignment with your needs is by observing the way the researchers handle your questions.
An exemplary research team will always be open-minded and understanding, providing clear explanations that are easily comprehensible, while giving you sufficient time to think. It is essential to note that informed consent is not a sales pitch.
If you are considering a study, read its Participant Information Sheet and ask the team about the protocol, visits, risks, data use and your right to leave. You can also read about Panthera’s knee pain and weight management trial. Eligibility depends on the sponsor’s criteria and is confirmed at screening; enquiring does not guarantee a place.
Disclaimer
This article is general information about questions to ask before joining research. It does not replace the study’s Participant Information Sheet or advice from a clinician who knows your circumstances.