Clinical trials which include ‘unapproved therapeutic goods’ (products that have not been evaluated by the Therapeutic Goods Administration (TGA) for quality and safety, and have not been entered into the Australian Register of Therapeutic Goods (ARTG) for general marketing), have to be approved under the CTN (Clinical Trial Notification) or the CTX (Clinical Trial Exemption) scheme, due to the products being considered as ‘experimental’.  

Now, if you go with professional CRO agencies like Novotech CRO or any other reputable names, you do not have to worry about it, as they will usually handle such methodologies from scratch. 

CTN (Clinical Trial Notification) 

A notification process. The Human Research Ethics Committee (HREC) reviews the scientific and ethical nature of the proposed clinical trial. The Therapeutic Goods Administration (TGA) is also notified about the clinical trial. 

Submission Process 

  1. The clinical trial sponsor has to notify the Therapeutic Goods Administration about any upcoming planned clinical trials and complete a form with specific information and the required fee. 
  2. The Human Research Ethics Committee (HREC) reviews all aspects of the planned clinical trial (whether the benefits are worth the potential risks and the ethical acceptability of the process). 
  3. HREC monitors the trial to ensure its integrity. 
  4. The approving authority gives the final approval for the trial to go ahead after receiving the necessary feedback from the HREC. 

CTX (Clinical Trial Exemption) 

An approval process. The Therapeutic Goods Administration (TGA) directly reviews the planned clinical trial and must give their approval for the clinical trial to go ahead. 

The CTN pathway is by far the most frequent regulatory pathway in Australia. In general, only what we call a Class 4 biological really has to go through the CTX pathway, and that’s a human somatic cell that’s had major manipulation such as the CAR T-cell in T-cell type therapy.

Submission Process 

  1. A sponsor submits an application to the Therapeutic Goods Administration (TGA) to apply for use of an unapproved product in a clinical trial. 
  2. If the Human Research Ethics Committee (HREC) approves it, the sponsor can carry out the trial.
  3. The TGA must still be notified about every clinical trial that takes place. 

The sponsors for CTN and CTX schemes are responsible for: 

  • Ensuring that Quality Assurance systems are in place. 
  • Gathering all relevant data. 
  • Ensuring that enough medical expertise is on hand for participant care.
  • Trial design. 
  • Record keeping. 
  • Ongoing safety evaluations. 
  • Completion of the Clinical Study Report. 

All clinical trials under the CTN or CTX scheme are carefully reviewed by the Human Research Ethics Committee (HREC) which operates in accordance with the National Statement on Ethical Conduct in Human Research.