What is it like to take part in a clinical study?

06 August 2021
Share

A clinical study involves research using people to further medical knowledge. They could investigate a variety of things, including testing new treatments, developing ways to diagnose conditions, or understanding causes of disease.

We fund clinical studies across all types of arthritis and musculoskeletal disease. Read more about our research.

What is it really like to take part in a clinical study?

Joanne is part of the HOPE-e study, which is supported by the National institute of Health Research (NIHR) and uses funding from our Centre for osteoarthritis pathogenesis Versus Arthritis. The lead researcher is Professor Fiona Watt.

The researchers recruited women at least one year after their menopause with painful hand osteoarthritis to test whether a particular form of hormone replacement therapy (HRT) containing oestrogen helps hand pain, when compared to a placebo (medication with no known effect).

We hope this research will help us to know more about the role of the menopause in the onset of hand osteoarthritis in some women, and whether we can improve symptoms or slow the process down with this type of medication.

So, over to Joanne to share her experience of taking part in this study:

What made you want to take part in a research study?

I have osteoarthritis in my hands. I wanted to try and understand it and find out what I could do in my life to make it easier, and to gain some improvements in my hand mobility and pain. I currently follow a diet that's directed towards reducing inflammation.

Where did you find out about the study?

I saw the piece around research using post-menopausal female volunteers with hand osteoarthritis, and I thought that’s me, I’ll do it!

Working for Versus Arthritis, it’s lovely to be a part of something that we have funded.

It’s also been incredibly interesting to take part in a detailed trial of a drug. I’ve never done anything like this before.

What is it like taking part in the trial?

It’s not just about taking a tablet every day, which of course might be a placebo – you don’t know if you’re taking the drug until the end of the project. It’s also about completing the paperwork to monitor your progress. 

You’re asked to score your pain levels every day and take photos of your hands to measure if swelling is increasing or not. 

You're also asked to record any additional pain relief that you take. Researchers are looking for a decrease in pain and inflammation.

What have been the positives and negatives of taking part in the study?

There are no negatives other than you need to be organised with your note taking, as you do get a large amount of paperwork and you have to return data at key dates. 

Fiona spends a great deal of time explaining more about the trial at the start, which from an ethical perspective is important that you know what you are committing to. 

Therefore, Fiona explains that although they know oestrogen is a safe drug, up to now, it hasn’t been trialled for this use; you have to be aware of the risks. 

The positives include feeling well supported. I had an initial visit down to Oxford where I spoke to Fiona. She wanted to carry out a face-to-face assessment as she needed to see my hands. 

Everything after that was done over the telephone due to the lockdown restrictions. I speak to Fiona every 6 weeks when my pain diaries are reviewed, she checks my results as well as my general health and wellbeing. 

She also links up with my local GP to ensure all results and blood tests, etc, are shared.

How long will you be involved in the study?

Phase 1 of the trial ended in July and in October I will be told whether I was taking the trial drug or a placebo. Even Fiona doesn’t know. I’m really interested to know what I've been taking!

If the results are significant for all the participants, the researchers are hoping to move to a larger scale trial after that, and I've said I'd like to continue to be involved.

Do you have any advice for people who are thinking about taking part in a clinical study?

There's lots of things to consider before taking part.

  • You need to be aware there may be potential side effects, but I felt in this case they were low, and it was all explained before the trial began.
  • There’s an assessment of your general health before you can start the trial, and additional tests through your GP.
  • Be open minded and accept that you may not feel any better, so it's important not to become too focussed on the end result. 
  • Don’t feel disappointed if there are no changes at the end of it. 

For me, it wasn’t just about your personal result, but about being part of something which might make women’s lives easier in the future. 

I have a family history of arthritis, specifically the women in my family. I believe that knowledge and treatment has improved through research. Certainly since my grandma had her knee removed for her arthritis many years ago. 

Due to this history, I felt it was really important to be a part of this, as it's specifically aimed at women.

It could improve the future for my two daughters and all those other women who are managing the menopause as we all as the pain of arthritis.

How you can get involved in our research

If you’re interested in participating in research, you can find details of research studies funded by Versus Arthritis that are currently recruiting on our find a research study page. You can also find opportunities on the National Institute for Health Research (NIHR) website.

Get the support you need

You might also be interested in...