Clinical Trials

The process of obtaining approval for a new medication takes years. Clinical trials are one of the most important steps in the approval process.

What is a Clinical Trial?

A clinical trial is a series of research studies in which people volunteer to receive a treatment (such as a drug) and be observed for its effects-both in terms of its safety and its effectiveness.
  • Any type of treatment can be tested in a clinical trial. Most clinical trials look at a specific illness; however, many evaluate new medical procedures or even preventive measures.
  • Before a clinical trial can begin with humans, it is first tested extensively in the laboratory and in animals.
  • Clinical trials are carefully supervised, monitored, and documented. The applicable regulatory authority must grant approval to conduct testing in humans, and clinical trials are overseen by an independent review body. 

How are clinical trials conducted?

CSL conducts clinical trials in accordance with the current Guideline for Good Clinical Practice (GCP) of the International Conference on Harmonisation (ICH). GCP is an international ethical and scientific quality standard for designing, conducting and reporting studies that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of study subjects are protected and that the clinical trial data are credible. Compliance with this standard also ensures that CSL conducts clinical trials consistent with the principles that have originated in the Declaration of Helsinki.

Current Studies

Bleeding Disorders
Hereditary Angioedema
Perioperative Bleeding
Therapeutic Proteins

Condition Additional Trial Information

Chronic Inflammatory Demyelinating Polyneuropathy

Extension Study of Maintenance Treatment With Subcutaneous Immunoglobulin (IgPro20) for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

> Learn More

Hemophilia A

An Open-label Safety and Efficacy Study of Recombinant FVIII in Patients With Severe Hemophilia A.

> Learn More

Congenital Fibrinogen Deficiency

An Observational Cohort Study of the Safety and Efficacy of Fibrinogen Concentrate, Human (FCH) in Subjects With Congenital Fibrinogen Deficiency

> Learn More

Primary Immune Deficiency

Study of Immune Deficiency Patients Treated With Subcutaneous Immunoglobulin (IgPro20, Hizentra®) on Weekly and Biweekly Schedules

> Learn More

Other inflammatory or immune system disorders

Dose escalation, placebo-controlled phase 1 study to assess the safety and tolerability of CSL324 in healthy adults

> Learn More

Page 1 of 2 Last

Trial Phases

Following a positive outcome in preclinical testing, the sponsoring organisation (usually a drug manufacturer) will seek approval to conduct clinical trials. Once approval has been granted, the sponsor will usually complete three phases of clinical testing in order for the applicable regulatory authority to approve the new treatment. An optional fourth phase typically follows approval. 

Apprentice Laboratory Technician, David Rüfenacht, tests a water sample at CSL Behring’s manufacturing facility in Bern  For each phase of a clinical trial, the sponsor collaborates with physicians to conduct the clinical trial, prepares a plan (or protocol) that describes the clinical trial, and submits detailed paperwork to the applicable regulatory authority and independent review board to obtain approval to conduct the trial.

Phase I-The process of testing an investigational drug on a small number of subjects to establish that it is safe for use in humans.  

Phase II-The process of testing an investigational drug on a small number of subjects to show it is generally safe and effective in treating or preventing a specific condition or illness.

Phase III-The process of testing an investigational drug on a larger population of subjects to show that it is safe and effective in treating or preventing a specific condition or illness.

Phase IV-The process of testing an approved drug in order to determine additional information.

© 2017 CSL Limited