Thinking about your research idea
Assessment of the risks and benefits of a new treatment/intervention needs to be based on reliable evidence. The most reliable evidence is best obtained by carrying out randomised controlled trials (RCTs) to compare outcomes of similar groups of participants who receive either the new intervention or the current standard intervention or, if there is no current standard, a placebo (or no active treatment).
Principles of Randomised Controlled Trials (RCTs)
A randomised control trial (RCT) is the best research method to determine whether there is a link between an intervention and an outcome. To look at the safety and effectiveness of an intervention, the evidence a RCT will provide, is the way to go. The most important thing an RCT will do, is reduce bias when testing the effectiveness of a new treatment. Participants will be randomly allocated in a group, either an intervention/experimental group where they will receive what is being assessed or a control group where they will get no intervention (or a placebo). A comparison will then be made between the two groups. Along with testing the effectiveness of a medical intervention, a RCT can also provide information, such as the effects a drug can have.
When designing an RCT you need to consider your research question. PICO is a focused clinical research question that consists of the following concepts;
P - population, patient, problem. Who are the patients you want to investigate?
I - intervention or exposure. What will be provided to the population?, e.g. surgery or services
C - the comparison or control. What can we compare the intervention with?
O - the outcome. What do you want to change or measure?
The trial protocol is the document that describes how a clinical trial will be conducted and ensures the safety of the trial subjects and integrity of the data collected.
Come and talk to us about your trial idea and we can work with you on protocol design to make your trial work for you.