WHAT IS A CLINICAL TRIAL?

Once a candidate drug has been tested and characterized in animals, it is ready to be tested in humans and enters the clinical phase of development. Initial clinical studies are usually performed in healthy male volunteers, testing single, followed by multiple, doses of the drug. A proof-of-concept study is conducted to provide the first evidence that a candidate drug might be effective for a disease. At all stages of clinical development, the criteria for continuing to investigate the candidate drug include safety, tolerability, pharmacokinetics, duration of action, efficacy, patient acceptability, and commercial viability at the planned time of launch.

The different phases of clinical trials/studies are described in the table below. Phase 1, 2 and 3 clinical trials are conducted prior to marketing of the drug, while Phase 4 trials are conducted after the drug has received marketing approval.

CLINICAL TRIAL PHASES

Phase Population type Scale
Duration
Main objective

Phase I

 

 

 

Healthy volunteers or patients (if cancer or AIDS is being studied)

 

 

Very small
Days

 

 

Safety
Tolerability
Pharmacodynamics
Pharmacokinetics 

Phase II

 

 

 

 

Patients
(hospitals) 

 

 

 

Small
Weeks

 

 

 

Safety

Tolerability

Proof-of-concept

Dose-ranging/finding
Preliminary efficacy

Phase III

 

 

Patients
(hospital or general practice) 

 

Large
Months 

 

Long-term safety and

efficacy vs competition drugs 

Phase IV 

 

Patients
(general practice) 

 

Very large
Months/years 

 

Long-term safety,

tolerability and efficacy

in real life patients

PARTICIPATION IN ACTELION TRIALS

To find out more about ongoing Actelion studies, please visit the Actelion clinical trial database.

If you are interested in participating in an Actelion clinical trial, please contact your physician.

 

US RESIDENTS

Please note that the information contained in this section of the website is not intended for US residents. Please visit our US webpage.

Please note that the information contained in this section of the website is not intended for US residents. Please visit our US webpage.

Key Account Manager, Sales and Marketing, France 

 

"I love to help people, and that is what we do."