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?

• 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

Condition	Additional Trial Information
Anticoagulant Reversal	Efficacy and Safety Study of BERIPLEX® P/N Compared With Plasma in Patients on Anticoagulant Therapy Who Require Emergency Surgery or Invasive Intervention > Learn More
Congenital Fibrinogen Deficiency	Fibrinogen Concentrate (Human) − Efficacy and Safety Study > Learn More
Emphysema Caused by API Deficiency	Study of Zemaira i.v. Administration in Subjects Who Completed a 2-Year Controlled Study With This Treatment and Have Emphysema Due to alpha1 -Proteinase Inhibitor Deficiency. > Learn More
Emphysema Caused by API Deficiency	Zemaira in Subjects With Emphysema Due to Alpha1-Proteinase Inhibitor (API) Deficiency > Learn More
Healthy	A Safety and Pharmacokinetics Study of a Recombinant Fusion Protein Linking Coagulation Factor VIIa With Albumin (rVIIa-FP) in Healthy Male Volunteers > Learn More

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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. 

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.