Clinical Investigations

MTAA is pleased to announce the release of a dedicated clinical investigation agreement for commercially sponsored studies of medical technology. Previously companies had to use an agreement developed with the pharmaceutical industry in mind that was not always suitable to cover the medical technology industry.

The new agreement has been developed in cooperation with the Victorian Managed Insurance Authority, New South Wales Health, and Queensland Health. The investigation agreement and associated forms have been based on similar documentation developed by Medicines Australia.

An important distinction between clinical study agreements developed for the pharmaceutical and the medical technology industries is the use of the international standard ISO 14155:2003 Parts 1 and 2 for the study of medical technology. The MTAA agreement references this standard. A number of issues in similar agreements released in the UK last year have also been incorporated into the MTAA documentation.

The agreement, forms of indemnity and compensation guidelines are available:

  1. The MTAA Standard Clinical Investigation Research Agreement
  2. The MTAA Standard Indemnity Form for a clinical investigation
  3. The MTAA Indemnity Form for HREC review only
  4. The MTAA Compensation Guidelines

Similar documentation for contract research organisations and studies by collaborative or cooperative research groups will be made available soon.

Clinical Investigations

The clinical investigations pathway for medical technology differs from the clinical trial pathway for medicines. While the clinical trial pathway for medicines typically follows phases I, II, and III (then IV post-market), the clinical investigations pathway for medical technology almost never goes through phase I (use in healthy volunteers). The clinical investigations pathway for medical technology is therefore more appropriately represented by the following stages:

  1. Stage 1 - feasibility or “first in man” (FIM) clinical investigation. This clinical investigation is usually conducted in a small number of patients with the disease to be treated, with assessment of the safety of the medical technology being the main focus of this clinical investigation. This clinical investigation is usually conducted prior to regulatory approval (pre-market).
  2. Stage 2 – pivotal clinical investigation. This clinical investigation is usually conducted in a large number of patients with the disease to be treated, with assessment of performance and safety of the medical technology being the main focus of this clinical investigation.This clinical investigation is also usually conducted prior to regulatory approval (pre-market), with the clinical data from this clinical investigation being mainly used to satisfy pre-market regulatory requirements.
  3. Stage 3 – post-market clinical investigation. This clinical investigation is conducted after satisfying the pre-market regulatory requirements, with the focus being to collect additional clinical data to assess a variety of endpoints, such as long-term performance and safety, health economics, etc.

For more information on clinical investigations, please visit the TGA website.