Volunteers are behind all new advances in healthcare, helping to speed up accurate diagnosis, find better treatments and transform the care of everyone affected by scleroderma.
Researchers need people to get involved from a wide range of backgrounds and with a wide range of symptoms and experiences of the condition – sometimes even if they have no link to the condition at all.
Can I take part in a scleroderma clinical trial?
You may be able to take part in a scleroderma clinical trial if you:
- Live with scleroderma
- Care for someone with scleroderma
- Are a family member of someone with scleroderma
- Do not live with a health condition
Understanding the term “healthy volunteer” in a clinical trial
If you’re taking part in a clinical trial, you may sometimes hear the phrase “healthy volunteer”. This can be confusing as researchers can use the words to mean two different things:
Meaning 1
Someone who doesn’t have scleroderma but who lives with another health condition
Meaning 2
Someone who does not live with a health condition
Each clinical trial will clearly explain what they mean by the term “healthy volunteer” and the kinds of participants they are looking for.
What are eligibility criteria?
Every clinical trial has rules about who can and cannot take part – in order to make sure people in the trial are safe, there are no potential effects on future children, and the treatment is suitable. These are known as eligibility criteria:
Inclusion criteria
a list of who can take part
Exclusion criteria
a list of who can’t take part
These details are clearly listed in the “Who can take part” section of each study description.
Why you may not be able to take part in a clinical trial
Each study has clear rules about who can join and there are lots of reasons why you may not be able to take part. This includes:
- your gender
- your age
- your medical history
- if you’re pregnant or breastfeeding
- if you’re taking certain medications
- if you have another medical condition that could affect the study results
These reasons are not a judgment. They are in place to keep all the participants safe and to make sure the research findings are accurate.
Sources (19)
- Clinical trials: National Institutes of Health (NIH) https://www.nih.gov/health-information/nih-clinical-research-trials-you/basics
“When you volunteer to take part in clinical research, you help doctors and researchers learn more about disease and improve health care for people in the future.”
- Randomised controlled trial participants – diversity data report: National Institute for Health and Care Research (NIHR) https://www.nihr.ac.uk/about-us/who-we-are/research-inclusion/randomised-controlled-trial-participants-diversity-data-report
“To benefit the NHS, public health and social care, research we fund needs to be widely applicable. And this means the people involved in health and care research need to be diverse.”
- Clinical trials: Scleroderma & Raynaud’s UK (SRUK) https://www.sruk.co.uk/research/taking-part-in-research/clinical-trials/
“By taking part in or supporting clinical trials, you’ll be helping researchers find the most effective ways to manage the symptoms and impact of scleroderma and Raynaud’s – not just for today, but for the future too.”
- Who can take part in health and care research: NIHR Be Part of Research https://www.nihr.ac.uk/get-involved/take-part-in-a-study
“Often studies look for people living with a particular condition.”
- Who can take part in health and care research: NIHR Be Part of Research https://www.nihr.ac.uk/get-involved/take-part-in-a-study
“Often studies look for people living with a particular condition. But others may be seeking people who care for someone with a long-term illness.”
- Recruitment Approaches for Family Studies: Attitudes of Index Patients and Their Relatives: National Institutes of Health (NIH) https://pmc.ncbi.nlm.nih.gov/articles/PMC4822817/
“A significant amount of… genetic research requires the participation not only of persons with a medical condition but also their family members.”
- Healthy Volunteers: National Institutes of Health (NIH) https://www.cc.nih.gov/recruit/volunteers
“Healthy volunteers provide researchers with crucial data because their health information can be used as a comparison. In some studies, researchers need to compare healthy volunteers with people who have a specific disease or condition.”
- Normal Healthy Volunteer (NHV): Advarra https://www.advarra.com/learn/clinical-trials-acronyms/normal-healthy-volunteer/
“Normal Healthy Volunteer (NHV) refers to a participant without the target disease who enrolls in a clinical study, most commonly in Phase 1 research.”
- Glossary of Common Terms: National Institutes of Health (NIH) https://www.nih.gov/health-information/nih-clinical-research-trials-you/glossary-common-terms
“A Healthy volunteer is a person with no known significant health problems who participates in clinical research to test a new drug, device, or intervention.”
- Eligibility Criteria: National Institutes of Health (NIH) https://clinicalinfo.hiv.gov/en/glossary/eligibility-criteria
“Factors used to determine whether a person is eligible (inclusion criteria) or not eligible (exclusion criteria) to participate in a clinical trial.”
- What is a clinical study?: NIHR Be Part of Research https://bepartofresearch.nihr.ac.uk/take-part-in-research/who-can-take-part/
“Each study will have its own eligibility requirements.”
- What is a clinical study?: NIHR Be Part of Research https://bepartofresearch.nihr.ac.uk/take-part-in-research/who-can-take-part/
“Each study will have its own eligibility requirements. […] It’s important you check these requirements before you apply. There may be restrictions depending on your […] gender.”
- What is a clinical study?: NIHR Be Part of Research https://bepartofresearch.nihr.ac.uk/take-part-in-research/who-can-take-part/
“Each study will have its own eligibility requirements. […] It’s important you check these requirements before you apply. There may be restrictions depending on your age...”
- What is a clinical study?: NIHR Be Part of Research https://bepartofresearch.nihr.ac.uk/take-part-in-research/who-can-take-part/
“Each study will have its own eligibility requirements. […] It’s important you check these requirements before you apply. There may be restrictions depending on your […] medical history.”
- Guideline for inclusion/exclusion of pregnant individuals in NIH IRP protocols: National Institutes of Health (NIH) https://irbo.nih.gov/documents/367/400-Guideline-Inclusion-Exclusion_of_Pregnant_Persons_and_Information_about_Pr_zJxIBNs.pdf
““There is an unknown risk associated with study interventions … where there is insufficient human data to assess risk to a pregnant woman or fetus.”
- Inclusion of women who are pregnant, lactating, or of reproductive potential in clinical trials: The Lancet https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)01497-7/abstract
“Randomised controlled trials have commonly excluded women who are pregnant or lactating… justified by an ideology of protection… in response to cases of drug-related fetal harm.”
- Inclusion & Exclusion Criteria: Dementia Research https://tdra.utoronto.ca/inclusion-exclusion-criteria
“Clinical trials also exclude people who are taking medications that may prevent the treatment being tested from being effective.”
- Inclusion & Exclusion Criteria: Dementia Research https://tdra.utoronto.ca/inclusion-exclusion-criteria
“ Example of exclusion criteria based on condition(s): In clinical trials for people living with Alzheimer’s disease, a diagnosis of schizophrenia may be part of the exclusion criteria because this condition can itself lead to memory problems.”
- Eligibility Criteria: Clinical Research Explained (VIARES) https://viares.com/blog/clinical-research-explained/eligibility-criteria/
“These criteria are established to ensure the safety of participants, the integrity of the data collected, and the overall validity of the research findings.”