FAQ

All clinical trials involving people have guidelines about who can participate. These factors are termed “criteria”, and there are often items that are required for eligibility (inclusion criteria) as well as items that are not wanted (exclusion criteria).  These criteria can include age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.

These criteria are used to identify appropriate participants, promote participants' safety, and ensure that researchers learn the information they need by reducing the influence of other possible factors.

Most clinical trials will require more than one group of participants. Groups are always defined by a characteristic or trait (i.e. criteria). For example, one group may have a disease and the other group doesn’t. Or there may be a cultural study looking for several groups of different cultures. In this sceneria, you will know which group you will be in.

However, sometimes the groups are randomly split into treatment and control groups. This is often referred to as a randomised control study (RCT). In most cases you will not have a say in what group you are in, and often, you will not know which group you are in. Additionally, the researcher may not know what group you are in. This is termed blinding and helps to ensure that the findings are because of the intervention or treatment only, rather than personal bias or the placebo effect.

Every trial is different, and the best way to find out what will happen is to read the participant information sheet and ask questions. However, there are things that are usually expected. Most studies will include measures, and experimental trials will also include an intervention.

Measures are specific for each study, and will be outlined in the participant information sheet. Some studies may simply require participants to undertake a couple of questionnaires, others may require blood sampling. It is important that you understand and know what to expect before you apply to become a part of a study.

An intervention is something that is given to you as part of the study that may or may not change one or more of the outcome measures. For example, an intervention could be a sports drink and the outcome measure is running speed. An intervention could be a new painkiller drug and the outcome measure could be reported pain. It is possible that the intervention you receive is a placebo or sham, and not expected to have an effect.

Some studies may require you to attend follow up sessions, sometimes separated by a period of time.

Once the study is complete, the researchers must collate all the data and run statistical analyses to determine what the outcome was. Once the results are complete, they interpret a conclusion. This is then submitted to a scientific journal for publication. Most studies will offer you the opportunity to have the findings explained to you in a simple language. However, you should understand that the process of analysing the data can take some time, so please be patient with your researcher.

Occasionally, the researcher may be planning a follow up study and will offer if you would like to be a part of this. This is entirely up to you and your decision should only be made after receiving sufficient information on the trial.