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Home : General public : What is a Clinical Trial?
What is a Clinical Trial?
A clinical trial is a research study, the outcome of which is designed to answer specific questions about new therapies, new ways of using existing treatments, as well as better ways to prevent, diagnose or treat diseases. Trials are used to investigate the efficacy, safety, tolerability and cost-effectiveness of a treatment. Trials may also be used to demonstrate a drug’s advantages over other treatments and identify the correct dosage for treatments. The treatment is tested on a sample of patients selected from a specific population.

Why do we need clinical trials?
What are the types of clinical trials?
What are the phases of clinical trials?
What is a blind or masked trial?
Why are patients randomised?
Who sponsors clinical trials?
What is a protocol?
What is a placebo?
What is a control or control group?

Why do we need clinical trials?

A clinical trial is one of the final stages of a long research process. Researchers test new therapies or procedures in a laboratory and in experimental studies. The treatments with the most promising laboratory results are moved into clinical trials. Carefully conducted clinical trials are the fastest and safest ways to find treatments that work in people.Clinical trials require huge financial investments as well as committed resources. To adequately evaluate a treatment, the duration of some trials may run into years, for example the EUROPA study, which was launched in 1997 and concluded in 2003.


What are the types of clinical trials?

Treatment trials are used to test new treatments, combinations of treatments, or new approaches to treatments

Prevention trials may involve medicines, vitamins, minerals, vaccines, or lifestyle changes. These trials are designed to find better ways of preventing disease in people who may be at risk of a disease, or wish to prevent the return of a disease

Screening trials are designed to find the best detection procedure for a disease

Quality of life trials usually involve people who are chronically ill and explore ways to improve different quality of life parameters, such as sleep, mobility and ability to work.


What are the phases of clinical trials?

Clinical trials are conducted in phases, with each phase providing the answers to different questions.

Phase I trials usually involve a group of less than 100 healthy volunteers who will be given a new drug or treatment. The outcome of this trial will determine a safe dosage range, the best dosage method, evaluate safety and identify possible side effects

Phase II trials involve hundreds of participants suffering from a condition relevant to the treatment. These trials further evaluate efficacy and safety of a study drug as well as identifying dose selection. The outcomes of phase II trials will determine the feasibility of evaluations for larger phase III trials

Phase III trials involve thousands of participants suffering from a condition relevant to the treatment and are designed to confirm efficacy, monitor side effects, compare it to standard treatments and collect any further information to assist in the correct usage of the drug. These trials may be multinational and involve many test centres. The EUROPA trial is the largest morbidity-mortality trial ever conducted with an antihypertensive agent specifically in all patients with coronary artery disease. It involved 12,000 patients and spanned 24 countries

Phase IV trials are usually conducted by the manufacturer after the product is approved and involve tens or hundreds of thousands of participants suffering from a condition relevant to the treatment. Additional information, including the drug’s risks, benefit and optimal use will be evaluated



What is a blind or masked trial?

In most clinical trials, a ‘treatment group’ will receive the study drug and a ‘control group’ will receive placebo or standard treatment. In a blinded or masked study, participants are not aware which group they are in. Physicians may also be blinded to the treatment a patient is receiving. This is called a ‘double-blind trial’, and is designed to prevent study bias, as some patients and physicians may expect better results on a study drug and therefore report hopeful signs.


Why are patients randomised?

In trials involving both treatment and control groups, participants may be assigned to either group by chance. This process is called randomisation and is used to avoid study bias and ensure that study results accurately reflect the treatment being tested.


Who sponsors clinical trials?

Sponsorship may come from a variety of organisations or individuals such as physicians, medical institutions, foundations, voluntary groups, pharmaceutical companies and national health institutes. Trials can take place in a variety of locations, such as hospitals, universities, GP surgeries and community clinics.



What is a protocol?

A protocol is a study design or blueprint on which all clinical trials are based. All information concerning the purpose, design, conduct and planned analysis of the trial are included. A protocol will describe what types of people may participate in the trial, the test schedule, procedures, medications, dosages and the length of the study.


What is a placebo?

A placebo is an inactive pill, liquid, or powder that has no treatment value. Placebos are often used as a comparison with experimental treatments to assess the treatment’s effectiveness. A placebo medication will resemble an active treatment in size and composition. In many diseases, the act of ‘taking a pill’ or being involved in a trial may significantly improve symptoms. This is called the ‘placebo effect’. A comparison against a placebo is clinically essential to assess the efficacy and tolerability of the trial medication against the background placebo level of response.


What is a control or control group?

A control is the standard by which experimental observations are measured. In clinical trials, a control group may be given a traditional treatment or a placebo. In the EUROPA trial, the study group received perindopril 8mg/day in addition to existing treatments, while the control group received a placebo in addition to existing medications.


This website is intended for an international audience. Drug related information may refer to unlicensed products or uses which may not be approved in your own country and you should therefore consult your local prescribing information.
This site is published and updated by the EUROPA study investigators. Site last updated March 21st 2006
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