FAQs

Ask your healthcare team about taking part in research

Answering your questions about taking part in research.

About pulmonary fibrosis research

What is pulmonary fibrosis research?

Pulmonary Fibrosis (PF) research asks questions which can advance 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?

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 most impacts quality of life most, and test ways to better manage symptoms, such as cough. We still do not know all the answers, and the only way to see things change is to support researchers working around the world, every minute of every day.

Are there different types of research?

There are many different types of research. These studies might ask participants to test different treatments, devices, or complete questionnaires. Some studies may not require any involvement from people affected by PF, but instead look at cells in a lab environment, animal models, or utilise computer modelling.

A study involving people can be:

Interventional – participants are given an active treatment decided by researchers. This could be a change in medication or lifestyle (e.g. exercise, diet, complementary wellbeing therapy, or symptom management). These are commonly known as clinical trials.
Observational – participants are assessed for specific changes over time, but researchers do not alter their standard treatment or care (e.g. questionnaires to understand the impact of symptom, or patient registries that track trends in how disease affects people or the services that are provided).

What is a clinical trial?

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 these lab experiments suggest it is safe, 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 single piece of research, whether it is “successful” or not, all adds to our knowledge and understanding of PF. Knowing what does not work is just as important as understanding what does.

Who conducts research?

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.

Should I get involved?

Are there other ways to get involved in research?

There are ways to help shape research other than directly taking part in a clinical trials. You can help shape the direction of research and make sure that scientific studies are focussed on the needs of people with PF. If you would like to find out more about opportunities to support PF research without taking part in a study, please email research@actionpf.org.

Why participate?

Taking part in research studies can be rewarding for people affected by PF for a number of different reasons. These can include:

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 an informed decision about whether participation is right for you and in your best interests.

Are studies and trials safe?

Taking part in research can feel daunting and many people say that their main concern is around safety. Research and clinical trials are more safe now than ever, due to the strict procedures and processes that are in place to protect participants.

The risk will vary depending on the type of study or trial. For example, taking a new medication has more risks compared to filling in a questionnaire. Any risks that are involved in a study will be fully explained to you before you agree to participate. This will usually happen during the informed consent process.

Trials which involve a new drug intervention will have already passed a large number of safety checks before being given to a human. New medication would have initially been investigated in laboratories on human and animal cells, or within 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. It is important to remember that 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.

The main focus of all trials is the safety of those taking part. This is overseen by the researchers or your healthcare team, depending on the individual study. Each study will have procedures in place should there be any problems reported by those taking part.

Who can take part?

Each trial will have its own eligibility criteria, which sets out if a person is suitable to take part or not. The type of person needed in the trial depends on the question that the trial is trying to answer.

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:

Type of PF
Age
Stage of disease, 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. Strict criteria also ensures that participant safety can be maintained at all times and risk is minimised. Being told that you are not eligible to take part in a research study can understandably be disappointing, however, you may still be able to take part in other research studies, which have a different eligibility criteria.

Can I change my mind?

Yes, you can change your mind and withdraw from a research study at any time, without providing a reason. This will not impact your care in any way. Depending on the type of study, you will be given support to withdraw. For example, if you are taking a medication, the researchers will help you to come off the medication safely. Researchers may still be able to use the information that they collected about you before you withdraw from the study.

What should I consider before taking part?

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/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?

Will I get paid to take part?

There are some research studies which have financial rewards 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, they 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.

How do I get involved?

Where do I find out about trials?

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.
In addition, clinicaltrials.gov may also be help provide more in- depth study information for clinical trials which are taking place across the world.

What practical considerations are there?

Taking part in research can lead to other challenges that may need to be thought through. These can include:

Location and travel requirements
Duration of the study
Potential side effects affecting day-to-day life
Taking time off work
Overnight stays
Childcare, and other caring responsibilities

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

Research studies will have a strict inclusion criterion, and this will vary depending on the trial. This will often set out the stage of disease that someone is at. Clinical trials typically include those who are newly diagnosed or in the early stages of the disease. This is to demonstrate the benefits of a new drug or therapy from the point of diagnosis, to understand if it stops or slows down disease progression.

Other studies that focus on symptom-management or the most suitable care, might involve people who are at different stages of the disease, including those in the latter stages. It is important to acknowledge that there are a lot of ethical issues and considerations that sometimes restrict research being carried out in the end stages of a disease, when the disease is very advanced and people are nearing end of life. However, we encourage you to discuss all options with your healthcare team.

What happens during the trial/study?

What happens on a study?

Researchers will collect information about you throughout the study. You may be provided with a new treatment or therapy, or you may be asked to share your experience of PF in the form of questionnaires, interviews, or discussion groups.

What is informed consent?

Informed consent is a process that takes place throughout all research studies. 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, but it may also be communicated to you verbally as well. At this point, it might be helpful to discuss the information with your family or friends.

Best practice for clinical trials is that a member of the research team will go through this 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 withdraw your consent (stop taking part in the study) if you wish.

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?

Some studies will take place remotely and entirely from the comfort of 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.

How are volunteers kept safe?

Your safety is paramount at all times within research studies. People who take part in studies are often in frequent contact with the research team and monitored closely. This means that you will often be seen more frequently by a healthcare team, compared to those who are just receiving standard care. The benefits of this can be providing you with greater peace of mind and also the opportunity for you to speak to a healthcare professional about any concerns you have. This closer monitoring can often be reassuring for those affected by PF.

If there are concerns for your safety at any point during a study, there are procedures that are in place to either stop the study or withdraw you if you experience challenges. If this happens, you will be supported whilst you stop taking part in the trail and this support will be followed up until any risks are no longer present.

What tests will I need to have?

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?

Different information will usually be collected at different stages of the 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. If you ever have any questions about the information that is collected about you, or want to know why it is being collected, please ask the study researchers.

Will the information collected about me be kept confidential?

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. The researchers will not tell anyone that you are taking part in the research, unless there is a problem involving your safety.

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.

What is a placebo?

A placebo is sometimes used in clinical trials to compare the differences between taking a new medication and not taking the medication, or a different type of intervention. A placebo looks identical to the new medication that is being investigated, but it does not contain any of the active substances.

Often, one group takes the active medicine and a different group takes the placebo. This is usually a randomised process determined by a computer or someone separate to the research team, where there is an equal chance of being assigned to either group. In trials like this, you might not be told whether you are in the active medicine or placebo group.

Studies are often designed so that even the researchers involved will 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’). The researchers then compare the results of the different groups to show whether the new medication made a difference.

Will there be any side effects?

It is never known how each individual will react to a new treatment, medication, or therapy. Some people may experience side effects, whereas others do not experience any difficulties. The research process will protect participants at all stages. If you do experience any side effects, it is really important to report these to the researchers or your healthcare team, so that they can support you with any appropriate management or action.

Can I keep taking my current treatment or medications?

Participants will not be asked to stop taking existing medication in order to take part in a study. Some studies will allow you to continue to take antifibrotic medication, as long as it is at a stable dose for a certain time period and there are no significant side effects.

Other studies may limit who can take part and only accept those who are not taking antifibrotic medication, or other medications not related to PF therapy. This may be when researchers are investigating new drugs and are concerned about how different drugs interact with and affect the body.

What happens after taking part in research?

After taking part in a study, the researchers will analyse the information collected and identify the similarities or differences between all the people who took part, whilst always maintaining your anonymity. The results will be analysed and compared with existing research.

Researchers often communicate their findings in research journals and at conferences, in order to share what they have learnt with other experts. This helps to move research forward and can ultimately lead to improve patient care.

Researchers will share the study results with you, if you request to see them. Sometimes researchers may ask for your permission to use the information collected about you in future research studies.

Some studies offer an extension phase of research, where people 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 receiving the active treatment . This is not available for all studies though .

If at any point in the research process you have any challenges or questions, it is always important to make sure that you contact the research team or your healthcare provider.

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