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LEARN Study: A checklist for people with Parkinson's Disease considering study participation

Making a decision to take part in a clinical trial can be difficult. There is lots of information to remember and how do you know what questions you should be asking about the research. Here we introduce a checklist developed with previous PD trial participants, to help potential participants decide about whether or not to take part in a study.

People who are thinking about joining a clinical trial or who are already taking part, have the right to ask the research team any questions they may have about the study.

You may not be sure of what questions to ask.

The questions below have been collated from working with people with Parkinson’s who have taken part in trials and with their support network. It may be useful for patients, potential study volunteers, and their family members or friends to use these as a checklist. The checklist can be used to assess your understanding of the participant information material you have been given about the trial, or as discussion points to raise with those who support you, or the research team. The research team will include doctors, nurses, study coordinators and other people who are involved in the conduct of a trial. This document is provided as a checklist, but for each section there is also a brief explanation for why this might be relevant to you and/or the study you are being asked to take part in. These are suggested questions, but there may be others you can think of that are more specific to the study you are thinking of taking part in. We have provided space for you to add your own questions as you think of them or to make notes. This is designed to go alongside any documents you receive from the research team.

We have defined some key terms here

Placebo: An inactive or ‘dummy’ substance or other intervention that looks the same as, and is given the same way as, an active drug or treatment being tested.

Treatment arm: A group of people that receive a particular study treatment. There may be different treatment groups in a trial, including group(s) that receive no treatment or who have a placebo.

Blinding: This describes a situation where you and/ or the researchers running the trial do not know if you are receiving the treatment or are in the placebo/ control group.

Screening: An evaluation before you are accepted into the trial to determine if you fit the criteria.

Assessments: A range of activities from questionnaires to physical tasks completed by yourself or with a researcher Off medication A period of time when your Parkinson’s medication isn’t working effectively or you deliberately haven’t taken medication for several hours.

 Brain imaging: There are different methods used for taking pictures of your brain which require you to lie still inside a scanner.

1. Ask about the purpose of the study and the people involved in running it

Some studies may relate to other research studies that have been carried out before and their results may have been published in academic journals. You may not be able to access these, but the team should be able to tell you what has been found previously and how that has affected the study you are considering getting involved in.

Some trials involve new drugs not given to people before, others are investigating if it is possible to ‘repurpose’ drugs that have been used previously for other conditions (one example is a diabetes drug that is widely used and has now been tested to see if it can help slow Parkinson’s disease). If the drug is already in use, a lot is known about its safety. These trials are still very important to do because it is necessary to know how the drug will work in people with Parkinson’s; the dose of the drug may need to be changed, or it might affect certain age groups in different ways.

Some trials (not all) involve a placebo or control. A placebo is a ‘dummy’ medicine or treatment, and for other trials that do not involve a medicine, it is more appropriate to use a ‘control’ group who do not receive the intervention being tested (ie the exercise programme, app etc). In some cases, the control group is ‘standard care’ which means that you will continue to receive treatment for your Parkinson’s in the same way you would if you were not involved in the trial. If you are in the placebo/ control group you will not have the treatment, but you will still undertake all of the assessments. You may or may not know which treatment group you are in depending on the design of the study.

Some studies will offer you the chance to get the intervention (treatment or exercise for example) at the end of the study, OR as part of the study but delayed compared to the main study group.

You may or may not want other people to know you are taking part, the decision to tell anyone outside of the trial team should be yours but your family doctor may be informed. You may want your regular doctor to know about the trial so that they can support your care afterwards.

There are different phrases (patient contributors, public patient involvement) used to describe the process through which people living with Parkinson’s can advise on the way a trial is designed. You may want to know how the study has involved people with Parkinson’s and what impact that had. Finding out how and when they have been involved may help you understand the trial and give you confidence that your needs are understood.

If it helps you to make a decision about whether to take part, you are able to ask the trial team and their previous experiences of running trials. 

You may want to understand their motivations for being involved in running the trial, they should declare any to you.

2 Ask about consent and screening

Screening is the process undertaken to determine whether you meet the criteria for the trial. If you do not meet these criteria you are not able to take part. It is important to open and honest in the screening process as these criteria can often be for your own safety.

You will go through a process of providing informed consent. This means someone should be explaining the study to you in depth, which may take place on more than one occasion. It may also involve videos, reading material and the opportunity to ask any questions and to read and understand the information given to you. You should understand what this means to you, what you have committed to and what the process is.

Sometimes changes occur through the course of the study, knowing how they will communicate these to you is important. You may decide to stop taking part in the study, or withdraw your data, for any reason. You have the right to do this at any time with no consequence for you, so ensure you understand how this can happen.

3 Ask about the treatment you may receive on the trial

When a control or placebo is offered, participants will be randomised to one group or arm, or the other. Many drug trials are ‘blinded’ which means you and/or the researchers do not know which group you are in. If the trial is blinded, it is likely that you will not be told which group you are in until the trial is complete. You should try not to think about which group you are in.

Treatments are administered in different ways and understanding how you will take the medicine and any special conditions associated with it may be relevant to you, for example is it a large pill you need to swallow, or an injection? The team should be able to give you an idea of what side effects to anticipate, this may depend on how new the drug is so you should know how to contact them if something unexpected happens.

4 Ask about what will happen to you during the trial

You may have been in studies or trials previously and while there will likely be similarities, all trials are different and may have unique aspects. Being confident you know what to expect from each part of the trial may help you feel more reassured or get the support you need.

Many studies require you to do several different types of assessments which will take more or less of your time and may be done on different days. Understanding this time commitment may be key for you.

Very often in drug trials it is important to conduct the tests both on your medication and in ’off’ which means that you would not take your medication overnight and would do the assessments without your medication. This enables the researchers to see what effect the drug might have on your symptoms. This can be a worry for some people and their support partners, and not everyone experiences ‘off’ in the same way.

Some assessments involve trying to measure what is happening in your brain by taking ‘pictures’ of it in a process known as imaging. There are different ways to image the brain, some involve magnets (MRI) or X rays (CT) and other involve a very small amount of radioactive drug which is injected in to you (PET). Some may require you to be scanned off your medication, but others do not require this. Knowing how the different assessments may impact your life and how long for, will be important for you and your support network.

5 Ask about your care

Your regular neurologist and/or general practitioner may be informed that you are taking part in the study but the information they receive may be limited.

It is very useful to know how they will be informed and what information they will be given. It will be important to understand how your Parkinson’s will be managed through the trial (if you need changes to your medication, if you get a new symptom or change). Your involvement in a trial may stop at any time and when this happens you will revert back to your normal care.

6 Ask about costs

Costs will vary depending on the project and your commitment.

It will also depend on the health system in your country. As a minimum your costs for taking part should be covered.

7 Ask about your data and privacy

Through the course of a study data about you and your Parkinson’s will be collected for you as an individual and then grouped with other people getting the same treatment as you.

If, how and when you may receive information collected about you will vary depending on how long it takes to recruit enough participants and the length of the trial, as well as time to process the data. Know what to expect and ask if they are getting your consent to stay in contact with you to allow you to receive this kind of information

8 Ask about support and information during and after the study

Individual trials differ in length and you may not know at the start what you might need later on as the study progresses. 

At the end of a study your own doctor continues to be responsible with your usual medical care. These questions may help you understand how you will be communicated with and how information is shared throughout and after the study is completed.

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