A big 'Thank You' to Margaret Hall, the Patient and Public Involvement Lead for Kent & Medway CLRN, who kindly agreed to let us use her FAQ's on this page!
What is a clinical trial?
In simple terms, a clinical trial is a research study related to the health of people. The idea behind a clinical trial is to find out if a new or different treatment works and if it is safe to use.
All health research studies have to follow a strict “protocol” or study plan. In order to safeguard the health of people taking part in a study the protocol is designed very carefully and precisely, and it has to be reviewed in the planning stages and then agreed before the study begins. The protocol is really important because it says what specific research questions are to be answered by the study, and describes what types of people may participate. It also includes details of important things like what procedures are carried out and how often, what medications are used and at what dose, and how long the trial will last.
In broad terms, clinical trials can be divided into two groups. These are “observational” or “interventional” studies. Observational studies are ones where the researcher observes individuals and makes a note of what happens or “monitors the outcomes” throughout the trial. Interventional studies are ones in which the investigator gives a treatment or some other sort of intervention to some study participants and then measures what happens.
Why do people get involved in health research?
Because we are all different, there are all sorts of reasons why people get involved in health research! Some people think that they’ll get more help and support with their condition if they take part in a clinical trial, while others are attracted by being able to get access to the new treatments that are being researched before they are widely available. Sometimes, taking part in clinical research can help participants to understand and manage their condition better and to feel that they are taking a more active part in their own health care too. Often, people are pleased to be able to feel that they are contributing to clinical research by being a participant because they recognise that research is the key to finding out more about their condition. They hope that by playing a part they will be able to assist doctors to find a cure – something that would benefit not only themselves but other people too.
Why are clinical trials needed?
We all want better health care, and clinical trials are often about improving the treatment of diseases or finding out how to diagnose people better. Clinical trials help health professionals to find out whether a new or different treatment is any better than an existing treatment, and to have real evidence to show what works and what doesn’t.
Doctors and nurses know only too well from what patients tell them how the complications of illnesses can have a huge negative impact on patient’s lives. Health care professionals want to do all they can to improve outcomes for their patients, and so it’s important that good clinical research is of direct relevance to patient needs and care. Doctors want to be able to continue with their important work to try to find new and better treatments, but they can only do so if people come forward and agree to take part in clinical trials. New treatments are by their very nature experimental, and sometimes a clinical trial will show that a new treatment isn’t any better than an existing one. On the other hand, the big breakthrough that everyone wants to see could be found as a result of the next clinical trial!
Are there different types of research?
Although there are different types of research, all of them are important.
Treatment trials: These test new treatments or drugs. Sometimes treatment trials are looking at different surgical techniques or other things like new approaches to radiotherapy.
Prevention trials: These trials are all about looking for ways to prevent diseases occurring in the first place, or to stop a disease recurring in someone who has already had the disease. Prevention trials can include medicines, but may also involve vaccines or even life-style changes.
Diagnostic trials: These are to find better procedures or tests to diagnose conditions.
Screening trials: These test the best way to detect certain diseases.
Quality of life trials: This sort of trial looks at ways to improve the comfort and quality of life of those people with chronic or long term conditions.
Who can get involved in research?
All sorts of people, whether young or old, can volunteer to take part in health research! And in relation to young people it’s really important that parents consider giving their children the opportunity to take part in health research because otherwise children are likely to miss out on the benefits that health research can bring. This is because when it comes to medical matters children are not just “little grown-ups”, and the best treatments for them are not necessarily smaller doses of the same medicines that are prescribed for adults.
Some studies need people with a particular illness or condition to take part, while other trials need healthy participants who don’t have the disease so researchers can compare people with the illness to those without. It is important to remember though that all clinical trials have guidelines about who can participate in a particular trial and who can’t. These are called inclusion and exclusion criteria and they help researchers to produce reliable results and ensure that participants have been identified appropriately. Inclusion and exclusion criteria are based on such things as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.
People can ask their own health care professionals eg GP, nurse, consultant about what research is going on in the area, if there is a study that might be suitable for them and how they could get involved. We are working to provide information on this website to tell you more about the studies that are going on in the Trent CLRN region
What's involved in research?
It’s really difficult to say exactly what’s involved and what happens in clinical research because it all depends on what sort of study it is. There are lots of different types of studies: some are long ones and these can be quite involved and take a number of visits over a long time, other studies are much shorter and only require 2 or 3 visits, and yet others might only need just one visit. In addition, some studies take place while patients are actually in hospital. This means that there is something to suit everyone!
So, what sort of things might you get involved in if you agreed to take part in a clinical trial? Firstly, if you were taking part in clinical research then you’d become a really important part of the research team, because no participants means no study! In many studies the chances are that you’d see a special research nurse, and on most visits you’d see a doctor too. What’s more, many of the things that you might have done in the clinic if you agree to take part in a clinical trial are the sort of tests you’d expect to have done anyway – things like being weighed and your height measured, having your blood pressure taken and blood tests for example, but you could have some extra ones too. This might mean that you would need to be in the clinic longer than you usually are – maybe half an hour or an hour, because throughout the trial the research team would be monitoring your health and checking for the safety and effectiveness of the treatment.
Some clinical research involves patients being given a questionnaire to fill in about their health, because research isn’t necessarily about trying out new medicines to see if they’re any better than existing ones. It’s just as important to find out why some people get diseases in the first place, why they then get complications of a disease and how to use drugs or other things like diet and exercise for example to help to manage their disease.
What information is given to participants?
It’s really important that anybody considering getting involved in a study fully understands what it is they are agreeing to. So, in order to make sure this happens, potential participants are given information about the study and are then given the opportunity to ask any questions they want to. Clinical trials can involve experimental treatments, so participants need to be aware that they may not be effective or they could have side effects, although the research team would discuss all this with you.
In addition to the information given in person, patients are also given a leaflet containing information about the study to take away and read. Research teams try really hard to make sure that the language used in the leaflet isn’t all full of medical jargon and is easily understandable by everyone. The research team knows that it is extremely important that patients are able to take the Patient Information Leaflet home to read at their leisure and away from the hospital or clinic. Firstly, it helps to make sure that everything about the clinical trial is covered and that nobody has forgotten to mention anything. Secondly, and no less importantly, it also gives people enough time to think about it, and to discuss things with their relatives, friends or carers before making a decision. These days, quite a lot of people look things up and read all about it on the internet too!
What is "informed consent"?
Informed consent is the process that takes place before someone agrees to participate in a trial during which they learn all about the trial so that they can decide whether or not to take part. It’s important for people to know and understand that it’s not just a question of the doctors and nurses providing information before the study starts. Informed consent is an ongoing process throughout a trial, and participants are provided with information to help them decide whether to continue to take part or not.
If someone decides they would like to take part in a trial, then they are given an “informed consent” document to sign. The document contains details about the study with all sorts of information like what it’s for, how long it lasts, what procedures will be carried out, any potential risks and benefits and so on. All of these things will have been explained and discussed with the patient, so unlike many consumer contracts there will be no clauses in very, very small print to watch out for or nasty “hidden surprises”.
Researchers understand that it’s important that nobody feels under any pressure to agree to participate in a trial, so they are always happy to answer any questions from relatives as well as the patient, and to make it clear that not taking part won’t make any difference to the care the patient gets. It’s important to realise that signing an informed consent document is not like signing a contract that commits you to something for ever, and at any time a participant may decide to change their mind and not continue with a trial without a problem.
Is taking part in research time consuming?
Although taking part in clinical research can mean giving up a bit of time, most people think that it’s well worth it. Sometimes participants in a trial are asked to come to the clinic more frequently at the beginning of a trial, and then to come less often as the trial progresses. How long each appointment takes depends on what’s being done, and because different sorts of tests are sometimes carried out at different stages during a study it’s impossible to say exactly what would be involved in any particular research, and of course, it all depends on what sort of trial it is too!
People who have had a condition for some time usually know only too well how hard the doctors and nursing staff work in order to help them with their condition. This means that if they are asked if they’d be willing to participate in a trial they see it as a way in which they can do something in return to help the doctors. And of course, the research may well be of personal benefit to them as well as other people in the future.
Members of the research team know that without patients being willing to participate they can’t do research at all. Patients who agree to take part in studies are really valued and appreciated by the research team, and it’s the patients rather than the doctors who are the stars of the show! Appointments are made as easy as possible for patients, so travel costs are taken care of too or even a taxi service may be used sometimes.
How are particpants rights protected?
The safety of patients and the confidentiality of any data they provide are of the utmost importance to researchers.
Health care professionals are trained in Good Clinical Practice (GCP). Before a trial begins the researcher has to make sure that he or she is complying with all the GCP guidelines and these guarantee that any research is carried out to the highest standards. Then, when funding for a study is sought, patient safety is high on the priority list for potential funders. Getting the approval of the Ethics Committee is another hoop that researchers have to jump through before they get the green light to go ahead with a study. Ethics Committees are there to ensure that the study is a worthwhile one, and that there is nothing in the study proposal that is going to be harmful to anyone. If the Ethics Committee is not happy then approval for the study will not be granted, and the study cannot go ahead.
Although many clinical trials take place hospitals – both outpatients and inpatients, research can also be carried out in a variety of other settings; GP’s surgeries or residential homes for example. Wherever the trial takes place though, patients have to feel certain that any information about them is kept completely confidential. In order to ensure patient confidentiality, there are strict guidelines for researchers to follow.
What are the main benefits of taking part in research?
We’re all different, so, not surprisingly, the benefits of taking part in research are not the same for everyone. Some participants feel that being in a study helps them to manage and understand their condition better. Other people say they get a real buzz from the fact that they’re playing a part in extending the boundaries of medical knowledge which may improve treatment for themselves and others. One of the benefits that some people mention is that they feel reassured as to their health in general due to all the regular checks they get from the big team of people looking after them during the study. The research nurses are always there to give support and advice or to answer any questions that patients might have.
A less obvious, but nevertheless important benefit of taking part in a study is the friendships that can be made. If a study is a long one then patients can get to know the medical staff and other patients quite well. Needless to say, this means that there are plenty of opportunities for making new friends. Being able to have a chat with someone who has the same condition and completely understands what you’re going through can be extremely helpful and supportive to people, and can help to make patients feel more positive about their condition too.
What are the drawbacks of taking part in research?
Life is sometimes described as a bit of an adventure, and taking part in clinical research can be much the same. It’s because it is research that it’s a journey into the unknown, and you need to bear in mind that the new treatment or new drug being tested isn’t necessarily going to be effective. In certain studies, not everyone is going to be given the new drug or new treatment. This is because it’s important to compare any new treatment with the existing one if there is one. Although there are occasions when it becomes obvious quite quickly whether one treatment is better than another, sometimes it is not until the study is over and the results have been analysed that anyone will know for sure which treatment is better. It’s important to remember that new doesn’t necessarily mean better.
It is possible that some new drugs may have side effects that the clinicians are not expecting or there may be risks attached to having a new treatment. As part of the consent process you will be told all about the new experimental treatment and any known risks involved so when you make your decision about whether or not to take part you know all the facts.
Some people find that it’s a bit of a chore at first having to get into what may be a new routine with their treatment. In certain trials participants have to keep recording things at home and sometimes people find it hard to remember to do this at first when they’re not in the habit of doing it, but on the whole people think that the advantages outweigh any disadvantages. Another possible downside is that it can be a bit stressful for members of your family who will almost certainly want to know all about what’s going on and exactly what’s involved. Occasionally people who’ve been involved in a study wish that they could carry on with research when a trial comes to an end, and they wonder how they’re going to feel when the study is over.
Why should I take part in research?
Most people who take part in research find it a really positive experience, but we know that other people may be put off taking part because they have a fear of the unknown. However, all the existing treatments were new treatments once, and it’s not really going into the unknown because all the information you need to decide whether or not to take part is available before you commit yourself. What’s more, a trial doesn’t last for ever, and you might find that it works out really well for you.
Whatever is being tested might actually help you considerably as well as being of benefit to future generations. But, if the results of the research show that the new treatment doesn’t work any better than an existing one we still need people to agree to take part in further trials because without them we stand no chance of being able to make progress.
So, how about giving it a go?