Frequently asked questions

The campaign is being launched to increase public awareness of the importance of randomised clinical trials in Scotland. These are the research trials that give the most reliable information on how best to treat medical conditions. We hope that by being better informed about randomised clinical trials the public will be more willing to take part in them. This will help doctors improve the care they can give their patients now, and in the future.

The commonest way a medical research trial is run is to give a new treatment to some patients and compare the results they get with another group of patients given an older type of treatment or possibly a ‘dummy’ treatment, called a placebo. However, human beings are all different and we have to ensure that each group in the trial contains a similar evenly balanced ‘mixture’. If we don’t do this and the group who gets one treatment is different from the group who gets the alternative treatment then the results of the research can be biased. A randomised clinical trial assigns the participants randomly to the treatment groups being investigated. The play of chance results in the two treatment groups being comparable. This means that any difference in the outcome experienced by the people taking the different treatments is down to the treatment they received and nothing else.

Random allocation of different treatments within the context of a research study is the most effective way to establish robust evidence as to how best to treat patients.

Doctors decide how to treat patients based on evidence from clinical trials. Prior to running such a trial there is uncertainty as to which treatments works best (if we knew which treatment was best we would not do a trial). Randomised clinical trials give the most reliable evidence and so are seen as the gold standard type of clinical trial.

A placebo is a fake or dummy treatment. A common example is a tablet containing no active medicine but which looks exactly like the tablet containing the medicine being tested. It allows researchers to make allowance for the 'placebo effect'. This is a psychological response where people feel better even though the treatment they are receiving is inactive. By comparing people’s responses to the placebo and to the treatment being tested, researchers can tell whether the treatment has any real benefit over and above the placebo effect. Treatments can also be compared with other treatments that represent usual care to tell if a newer treatment is better, the same or worse than established treatments.

Most clinical trials need participants who already have the medical condition under study. Various guidelines are built in to the trial concerning the criteria people need to meet to be eligible. The exact details are specific to each study but in general many more people would be eligible for a clinical trial than ever apply for one.

No, but it is necessary to be able to give informed consent. Some trials enter only certain age groups, for example some only study older people. The details vary from trial to trial.

By participating in a randomised clinical trial patients are helping establish robust evidence as to the best way to treat a certain condition or illness, for themselves and for future generations. Taking part in the trial itself cannot guarantee better treatment although trials often see patients more frequently than normal care. Taking part in a trial is essentially an altruistic act. To some extent it is similar to donating blood. There may be no direct benefit to the patient from donating blood but sometime in the future they may benefit from a donation made by someone else. The only difference with trials is that when the results are known patients in the trial may all be switched to the best treatment.

Some degree of risk is attached to medical treatment and clinical trials just as it is to life in general. The known risks of any clinical trial have to be very clearly set out before anyone is asked to participate. Great importance is given to providing enough information to patients so that they may give their ‘informed consent’ knowing all the facts. Many clinical trials compare treatments that are already being prescribed by doctors and are in common use. In those cases there is already a lot of knowledge about the safety of the treatments and what is being investigated is the best way to use these treatments.

Potential risks always have to be justified in the context of the illness being treated. For example it would be unacceptable to use a new treatment that gave great results for sore throats if that treatment had a high risk of serious side effects. A sore throat is a nuisance but a minor one and does not justify taking a potentially dangerous drug. On the other hand a new treatment for someone with advanced cancer may carry the risk of serious side effects that are felt worth running if the drug also gives good results against the cancer.

Clinical trials must comply with a wide range of strict rules before they are allowed to go ahead. The most important of these rules are to do with patient safety. The study protocol is laid down before the start of the study and spells out exactly what will be done in the study, how it will be done, and why each part of the study is necessary. The same protocol is used by every doctor or research centre taking part in the trial. The patient is protected by careful adherence to the protocol as well as by close monitoring and reporting of all serious adverse events to the investigators.

Participation in clinical trials is always voluntary. People can withdraw at any time without giving a reason and revert to their normal care

Producing detailed information for potential participants is one of the things that researchers have to do when organising a clinical trial, so people should look at this information carefully. Any questions on the trial should be answered by speaking to the research team, or the person’s GP or nurse.

Yes the full results of randomised trials become a matter of public record and the participants are made aware of the conclusions on completion of the study. The best possible outcome of a randomised clinical trial is that it adds to the body of conclusive evidence concerning the most effective way to treat a certain condition or illness.

Patients are not paid to participate in randomised clinical trials.

Early stage clinical trials which test new drugs may use 'patient volunteers' who receive some payment but this is a different situation from randomised clinical trials. Usually trials do reimburse out of pocket travel expenses incurred by patients participating.

Lots of different organisations fund clinical trials. The Department of Health, Medical Research Council, universities, charities and pharmaceutical companies are the main sponsors. No matter which body funds a trial, they are all run to the same high standard.

Most trials have a trial steering group or committee. This ensures the trial is run properly. In the UK, this committee often includes patient representatives as well as the researchers, doctors and nurses who are leading the trial.

They also usually have a data monitoring committee that follows the progress of the trial. The people on this committee are independent. If they think that a trial should not continue they can advise that a trial is stopped.

Information on clinical trials in the UK is collected across a number of databases. For example the UK Clinical Trials Gateway (http://www.controlled-trials.com/ukctr ) currently lists 3810 clinical trials, not all of which are randomised. These range across a very wide range of topics in internal medicine, surgery, psychosocial medicine and public health.

Randomised clinical trials may involve primary care (GP surgeries, community nursing services, etc) secondary care (hospital based) or usually a combination of the two. Randomised Clinical Trials often also involve academic institutions (universities and medical schools). They may be carried out within a wide range of environments, from the in-patient hospital ward to anywhere in the community, depending on the nature of the trial.

See answer to Q 16. There are several other databases, such as Cancer Research UK’s clinical trials list at
http://www.cancerhelp.org.uk/trials/trials/.

www.getrandomised.org will list an increasing amount of information on randomised clinical trials in Scotland and the rest of the UK.

The four Scottish Universities – University of Dundee, University of Glasgow, University of Edinburgh and University of Aberdeen.

Yes, The Chief Scientist Sir John Savill and the Chief Medical Officer Prof Harry Burns have approved the Campaign.

A variety of methods are used but mostly it is doctors asking patients if they would like to participate Sometimes people with a particular condition seek out for themselves information on clinical trials potentially relevant to them, but this can be difficult for the lay person to do. Links to help people become informed about randomised clinical trials going on in the UK will be added progressively to the Get Randomised campaign web site, www.getrandomised.org.