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Frequently asked questions

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Ask your healthcare team about taking part in research

Here we answer your questions about taking part in research.

About pulmonary fibrosis research

What is pulmonary fibrosis research?

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Pulmonary Fibrosis (PF) research asks questions which can improve our understanding of the disease and make progress towards faster diagnosis, new and better treatments, symptom control, and improved services and care. To do this, researchers need to gather the answers to lots of different questions. These often involve answering when, where, what, why, and how questions, such as:

What causes PF?
When do people develop PF?
Why does PF progress more quickly in some people than others?
How can we help people to better manage their symptoms?
How can we stop PF?

Why is research important?

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Without research, many diseases which were once highly prevalent, such as smallpox or polio, would never have been eradicated, and treatments for other conditions would not be available. All currently prescribed treatments for PF, such as antifibrotic medications, are available because someone like you took part in research to determine that they are safe an effective.

Many questions about PF still remain unanswered and it is vital that we find out new information to help inform better care for people affected by the disease. Understanding why PF develops and finding new treatments is vital if we are to find out how we can stop fibrosis. Research also helps to identify areas where PF impacts quality of life most, and test ways to better manage symptoms, such as cough.

What is a clinical trial?

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A clinical trial is a medical research project involving people. They are designed to investigate the effects of a new intervention (e.g. drugs, devices, care pathways) on disease or human health. Researchers often identify a possible new drug or device, and first test this in the laboratory. If the results are promising, then it will be tested with people in a clinical trial. Clinical trials can look at different aspects of the disease, such as:

The causes and risks of developing PF
Preventing PF
Diagnosing PF
New treatments
Managing side effects

The overall aims of clinical trials can answer questions such as:

Is it safe?
Does it have any unwanted side effects?
What is the most effective dose?
Does it work better than other treatments available?
Does it negatively impact quality of life?

Clinical trials can tell us if a new treatment or intervention works better than a previous therapy. However, not all clinical trials will identify new and better treatments. Some results will show that a new treatment does not work, is not as good as other treatment options, or that the side effects are too great compared to the benefits of the treatment. But every piece of research, whether it is “successful” or not adds to our knowledge and understanding of PF.

Who conducts research?

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There are a variety of different organisations that carry out research, such as: hospitals, universities, research organisations, pharmaceutical companies, private companies, and charities.

Researchers are not just people in white laboratory coats looking through microscopes (although they can be). Researchers can also be part of your clinical team who are looking after you. Often, they will be involved in research in some way as part of their clinical practice.

We encourage you to ask your consultant and healthcare team about research. Talking about research can open the door to new opportunities for both you and your healthcare team, empowering you to play an active role in creating a brighter future for other who are also affected by the disease.

Thinking about taking part in research

Why might I consider taking part in research?

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Taking part in research studies can be rewarding for people affected by PF for a number of different reasons. People affected by PF have told us they take part for many different reasons, including:

The chance to access to new treatments that might help your symptoms and/or life expectancy
Helping other people with PF both now and in the future
Understanding more about PF
Gaining insight into how the disease affects you
Greater contact with your clinical healthcare teams and researchers
Connecting with other members of the PF community

Participation in research is very much an individual choice, and it may not be right for everyone. It is important to have all the information that you need in order to make a decision about whether participation is right for you.

Are there other ways to get support research without taking part?

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Yes, there are other ways to support research without taking part. You can share your lived experience with scientists to help shape their work and improve the impact of their research. If you would like to find out more about how you can use your voice to shape research, email involvement@actionpf.org.

You could also support research through our Hope for All Research Appeal.

Are research studies safe?

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Taking part in research can feel intimidating and many people say that their main concern is around safety. There are strict procedures and processes in place to protect participants. There will always be an element of risk involved.

The risk will vary depending on the type of study or trial. Any risks that are involved in a study will be explained to you before you agree to participate. This will happen during the informed consent process.

Trials which involve a new drug will have already been through many tests before being given to a human. New medication would have initially been investigated in laboratories on human and animal cells, or in animals, before eventually being tested on people. With new drugs there may be a risk of experiencing side effects, just like taking any prescribed medication, as it is not known how each person will respond. Not all drug intervention studies involve new medications; some studies look at commonly prescribed drugs that are used for other health conditions, to see if they are effective in people with PF.

Will there be any side effects?

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There is no way to prevent you from experiencing a side effect, however it is always your choice whether you participate or continue to participate in a clinical trial. Some people may experience side effects, whereas others may not. If you do experience any side effects, it is important to report these to the researchers or your healthcare team, so that they can record these and support you with any appropriate management or action.

Can I change my mind?

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Yes, you can withdraw from a research study at any time, with or without providing a reason. This could be because of side effects, scheduling challenges, because you are no longer interested in participating in the study, or any other reason.

Researchers may still be able to use the information that they collected from you even if you withdraw from a research study. For some studies, you may be asked to continue with other study procedures (for example, continuing to do breathing tests as part of the study) even if you stop the medication being tested. This ongoing participation is optional, but is often helpful to answer the question of whether the medication did or did not help patients.

Your healthcare team will continue to care for you after you stop your participation in a research study. Your decision to withdraw from a study will not impact any other part of your care.

What questions might I ask before taking part?

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You should always speak to your healthcare team when considering taking part in research. Every trial has different aspects to consider and not every trial will be right for you. It is vital to get as much information as you can and ask about the things that are most important to you. The questions you ask may vary depending on the type of research study, and might include:

What are the aims of the research study and how will this help people affected by PF?
What type of research study is it?
Are there any risks including potential side effects/benefits of taking part?
What is the treatment?
Has it been given to people with PF before and did this provide benefits?
Will there be a placebo given to some people taking part?
Will I know if I have been given the new treatment or a placebo?
Can I contact someone if I have any questions or concerns?
Will I be given the results of the research study?
What is the location and travel requirements?
What is the duration of the study?
Are there overnight stays?
How much time will it take up? (Impact on work, family life, caring responsibilities?)

Will I get paid to take part?

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There are some research studies which have financial reimbursement for taking part, however, not all studies offer this. You might be reimbursed for travel expenses, or other expenses incurred, or you may be compensated for your time as a result of taking part in research. However, this will largely depend on the individual study and factors such as the research aims, location, and people who are organising the research. Whilst these factors may seem rewarding, these should not be the only reason for signing up to take part in research. It is important that you consider all aspects of the research studies and weigh up the potential risks and benefits of taking part.

Can I keep taking my current treatment?

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What medication you can and cannot take during a research study will depend on each individual trial.

Some new medications being tested will interact with other medications you might already be on. In most cases, that will mean a patient does not participate in that study, although sometimes a decision could be made to stop a previous medication such that you can take part in a trial. This decision would need to be carefully discussed with your healthcare team.

Some research studies are only for people who are not already on treatment. If you are already on a medication that is working for you, you typically should not be asked to stop that medication in order to take part in a new trial.

Other research studies allow patients to continue all previous medications, but may require that you have been on a stable dose for a period of time (usually for around 12 weeks).

How do I get involved?

At what point during my illness or treatment can I take part?

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There are many reasons why people can and cannot take part in research. The stage of your disease and the treatments you are prescribed will affect whether you can take part or not. Clinical trials often include people who are newly diagnosed or in the earlier stages of disease. This is so that the effects of a new therapy can be studied to understand the difference the drug can make to the progression of the disease.

However, other studies involve people who are at different stages of disease, including those in the latter stages. These studies may focus on symptom-management or collect data over longer time periods, for example a patient registry. We encourage you to discuss your options with your healthcare team.

Who can take part?

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Each trial will have its own eligibility criteria, which sets out if a person is suitable to take part or not.

Eligibility criteria will differ depending on the research study and will typically consist of a set of characteristics that a person must meet, such as:

Diagnosis
Age
Severity of pulmonary fibrosis, often relating to lung function test results
Symptoms
Other health conditions
Treatments and medications that someone is currently receiving or has previously received
Acute exacerbations

The criteria are set out to ensure that the research question being asked, can appropriately be answered. Being told that you are not eligible to take part in a research study can be disappointing, however, you may still be able to take part in other research studies.

Where do I find out about research studies?

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You can find out about taking part in research in a variety of ways.

Speak to your consultant and healthcare team. Let them know that you would be interested in hearing about opportunities to take part in research, and ask if they are aware of any studies that you may be able to take part in.
You can explore opportunities to take part in research on our website, through our research news articles and Find a Study webpage.
For clinical trials happening worldwide, you can visit clinicaltrials.gov

What happens during the study?

What is informed consent?

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Informed consent is a process that takes place in research studies. Informed means that a patient is aware of the benefits and risks of taking part in the study. The people who are in charge of the study must ensure you:

have all the information about what will happen during the study
understand the purpose of the study
know how information about you will be used
are aware of any potential risks or benefits of taking part
are kept updated with who to contact if there are any problems or questions.

There is usually a participant information sheet containing all this information for you to take home and consider before deciding to take part, but it may also be communicated to you verbally as well. It might be helpful to discuss the information with your family or friends.

For clinical trials, a member of the research team will go through all the information with you to ensure that you understand everything, and give you the opportunity to ask any questions that you may have. You will then usually be required sign a form to say that you have understood the study and agree to participate. You can reconsider your participation at any stage and stop taking part in the study.

The informed consent process may be different if the research study is taking place remotely or online. Each study will have a slightly different procedure and all information provided will only be applicable to that specific study. No two studies will be the same, so it is important to understand all the information being given to you, so that you can make an informed decision about whether to take part or not.

Where does the research take place?

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Some studies will take place remotely from your own home. Other studies will take place in a hospital or clinical setting. They could also be a mix of the two, with a hybrid approach to research.

What tests will I need to have?

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If you decide to take part in research, the tests you are asked to complete will depend entirely on the study. Different tests can include:

Blood tests
Lung function tests
X-rays, HRCT (high-resolution computed tomography),or other scans
Questionnaires
Fitness tests, such as the 6-minute walk test

What information will researchers collect about me?

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Information will be collected throughout a study, and some studies will repeat the collection of the same information to understand how things can change over time.

Information collected can include:

Age
Gender
Ethnicity
Occupational background
Diagnosis
Blood test results
Lung function test results
X-rays or HRCT (high-resolution computed tomography)
Questionnaires recording quality of life
Impact of symptoms
Details about other health conditions that you may have
Results from other clinical tests

This is not an exhaustive list and the information collected will vary between research studies.

Will my data be handled confidentially?

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How your data will be looked after will be explained to you before you take part in a study. Typically, all information collected will be anonymised and no identifiable information will be shared with other researchers outside of the study. The information collected will be kept confidential and only information that is relevant for the purposes of the research study will be collected.

After the study has finished, the researchers may publish the results in scientific research journals or present the results at conferences to share the findings with other experts. However, the information will be anonymised, and it would not be possible to identify you as an individual. Sometimes your anonymised data will be shared with other researchers for future study where ethical approval is granted. You may be asked about this possibility in the initial consent process.

What is a placebo?

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A placebo (dummy drug) looks identical to the potential medication that is being investigated, but it does not contain any active ingredients.

Often, one group of participants takes the active medicine and a different group takes the placebo. The decision about who is given the placebo is normally determined by randomly allocating people to either treatment or placebo. If you are in a trial that has a placebo, you will not be told whether you are taking the active medicine or the placebo. A placebo is used so that the researchers can be sure that the effects of the potential treatment are real, and not due to a participant merely believing the drug is working - a phenomenon known as the placebo effect!

Studies are often designed so that researchers also do not know whether you have received an active drug or a placebo until after the study has finished. This is known as participant and researcher blinding (or ‘double blinding’).

What happens after I have taken part?

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What happens next will depend on the type of research you have taken part in. Some clinical trials offer an extension phase to the research, where participants may be able to continue to receive the new drug or therapy after the initial trial has finished. The extension phase is often ‘open-label’, which means that you will know that you are now receiving the active treatment. Patients who were initially on the placebo may also be able to take the new drug during an extension phase.

Researchers will need time to analyse any data that was collected and understand what new information or knowledge has been learnt. This process can take a long time and there can be a long delay between a study closing and results being made available to the public and the people who took part.

Researchers often share their findings in research journals and at conferences. We encourage you to ask how you will be told about the results when you are deciding whether to take part.

Not found what you are looking for? Please email research@actionpf.org if you have any questions.

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