We'd love to inform you on what a clinical study actually is. Learn more about the phases of a clinical study below.
PHASES OF A CLINICAL STUDY
To assess the initial safety of an investigational drug in a small number of participants (usually 6-10).
To evaluate safety further by testing it on a larger group of participation (usually 20-300).
To assess safety and efficacy on larger number of participants; tested against any existing treatments (300 - 3,000).
To collect information about safety and efficacy in a "real-world" setting following a drug's approval for use.
There are risks of taking part in any clinical study, some of which are listed down:
Thousands of people all around the world take part in clinical studies every year. Without them, new treatments simply cannot be developed. After all, the results of such studies must be submitted to various regulatory bodies to prove they are both safe and effective. So without this information, no new medication scan be approved.
There are many reasons people take part in a clinical study, some of which are listed below:
In general, you will be first asked to read and sign an informed consent form. This describes what will happen and when. Once this is signed, the study team will carry out some assessments to check that you and the study are a good fit. If you are, you will be assigned a regimen of study drugs. You'll also be asked to come to a study clinic for health checks. Theses clinics are often hospitals or research centers. However, every study is different. SO the number of visits and time between them will be different from study to study.
A placebo is a dummy drug that contains no active ingredients. Many clinical studies are "placebo-controlled". This means that some participants receive the investigational drug and some receive a placebo. Researchers can then compare the results from those taking the investigational drug to those taking a placebo. This helps them to see whether any differences between the groups are due to the investigational drug or some other factor.
Placebo-controlled studies are usually "double-blind". This means that neither the participant nor the study doctor know which study drug they are receiving. However, healthcare staff can find out in case of an emergency.
No. All study-related drugs and assessments will be provided at no cost to participants. Some people find traveling to and from the study site for their visits a bit of an inconvenience. Although this isn't technically a "risk" it's something worth considering before you decide to take part.
And finally . . .
Of course, taking part in a clinical study is a personal decision and no one has to join if they don't want to. It's also important to know that if participants join a study and then change their mind, they can leave at any time without any impact on the study.
ClinCloud clinical research is a state-of-the art clinical trials research facility located in the Orlando, Florida metropolitan area reaching a diverse population of 2.77 million.
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