A clinical trial is a scientific study involving a new medication, treatment or device. Before a medication is approved, it must first go through phases of a trial. During this stage, participants are often not aware of the drug they are taking. After a phase III trial, the drug will usually move on to the next step, which is a phase IV trial. This stage involves thousands of participants and can last for many years.
During the phases of the trial, the participants receive more attention and tests. These include X-rays and ultrasounds. They may also undergo medical tests. If the drugs do not cure the disease or are associated with harmful side effects, the research team will stop the intervention. In some cases, the trials will end early, so that no one is harmed by the experiment. Once the researchers determine whether or not a drug is effective, they will decide whether or not to continue the study when they might choose to incrementally increase the dosage at safe levels.
During a drug trial, participants may be asked to undergo more doctor visits and tests than usual. The reason for this is to monitor the results of the treatment. The researchers may also ask about possible side effects, which are known as adverse events. Although the symptoms of these side effects are not always fully understood, participants should let the research team know if they experience any unusual symptoms. They will determine whether the side effects are related to the drug.
The sponsoring organisation of a clinical trial may decide to discontinue or delay the trial. This can be extremely disappointing to participants, and prevent them from receiving a new treatment that could cure them. Sometimes, however, the drugs are deemed ineffective and the research continues. This is a complex decision, and the sponsors have to carefully weigh the benefits and risks before the trial is even started. The process can take years. Find out more about what happens to Clinical Trial Volunteers at https://www.trials4us.co.uk
Before a clinical trial, participants must provide written informed consent. The researchers will answer any questions they may have. The consent form will contain several confusing terms and phrases. Make sure you ask questions before signing the form.
Participating in a trial can be a hugely rewarding experience. Depending on the type of trial, what it is involved with and how long it will last, there will undoubtedly be many questions that volunteers will want to ask before signing on the dotted line. These could include finding out how long a volunteer might need to be away from home or work. Will there be any financial remuneration? Will there be information after the trial to find out the results and whether the trial was a success or not?