What is clinical research?
In clinical research studies, also called clinical trials, people volunteer to receive an investigational medication under closely monitored conditions. The studies are designed to find out if the investigational medication is safe, and if it works. Health authorities use the information from clinical trials to decide whether new medicines should be approved for routine medical use.
Why do people take part?
Participants in a clinical research study may receive an investigational medication before the Health Authorities have decided whether or not to approve the drug for general use. They also play a vital role in advancing treatment options. Without volunteers we would have no new medications.
However, it is important to remember that there may be limited information about how safe the investigational medication is, how it works, and whether it works at all. Participants in clinical trials might not benefit and could possibly even get worse. For this reason, volunteers are carefully screened before taking part and are closely monitored throughout the clinical study.
Some participants value the additional time and support from expert study doctors and nurses during the study visits and assessments and feel that they learn more about their condition.
Importantly, the decision to take part is completely voluntary. If study participants change their minds, they can choose to leave the study at any time, for any reason.
Find out about taking part in our current
and future PH1 clinical research studies.
Clinical research terms
There is a lot of industry jargon when it comes to clinical research. Here are some key terms you should be aware of.
Investigational medication: This is a medicine that’s being studied. Typically, this medication is not yet approved by health authorities for medical use and is not yet available for the condition being studied.
Study site team: This is the team of doctors, nurses, and other professionals who are conducting a clinical research study at a particular clinic or hospital. The doctors are often referred to as “investigators” for the study.
Randomization: The best way to test how well a medication works is to compare it to an alternative treatment, which would be current therapy or a placebo (see definition below). To do this without bias, participants are randomly assigned, like the flip of a coin, to receive either the investigational medication or the alternative treatment.
Placebo: If there are no current therapies, then a placebo, or “dummy medicine,” may be used instead. A placebo looks like the investigational medication but contains only inactive ingredients, such as saline.
Blinded: Sometimes, if patients think they are on a strong medicine, their expectation that they will get better has an impact on their response beyond the actual effect of the medicine. This is called the “placebo effect.” To prevent this placebo effect, in a “blind” clinical research study, participants do not know if they are taking the investigational medication or the alternative medication. In a “double-blind” study, neither the participant nor the study site team knows which treatment is being given.
Protocol: This is a detailed plan that describes how the study site team will administer the investigational medication and monitor its effects. The protocol must be approved by health authorities and ethics committees or institutional review boards (IRBs) to make sure that the interests of participants are protected and the plan is scientifically sound.
Independent ethics committee (IEC) or institutional review board (IRB): This is a committee consisting of both medical experts and members of the general public who review, approve, and monitor all clinical research studies involving people. They have to make sure that studies are conducted in accordance with the relevant regulations, and that the rights and welfare of participants are protected.