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:
- The MTAA Standard Clinical Investigation Research Agreement - Updated July 2017
- The MTAA Standard Indemnity Form for a clinical investigation
- The MTAA Indemnity Form for HREC review only
- The MTAA Compensation Guidelines
Clinical Investigation Research Agreements (CIRAs) for Clinical Research Organisations (CROs) will be made available soon. There are no specific CIRAs for Collaborative/Research Groups (CRGs) being developed at this time.
Companies and other sponsors of clinical trials may start to use the updated CIRA templates from 1 July 2017.
There is no need to revise the CIRA for any clinical trial which has already been submitted to an HREC for review, or for any clinical trial that has commenced.
Between 1 July 2017 and 30 September 2017 companies and other sponsors of clinical trials may choose to either use the current versions of the CIRA templates or newly-released versions for clinical trial projects. Both are acceptable.
For all new clinical trials for which submissions to HRECs will be made on or after 1 October 2017, the new CIRA templates must be used.
In relation to any amendments to the template CIRAs that have previously been approved by the SEBS for inclusion in Schedule 7, these amendment clauses do not need to be re-approved. This includes if there is a change to the number of the relevant clause – companies and other sponsors may simply change the numbering as required, retaining the same wording as previously approved by the SEBS committee.
The agreements are made available as unlocked MS Word Documents. In using the standard CIRAs note in particular that: “Any textual change to the body of this Agreement is to be ignored, and reference instead had to the standard form, as amended by Schedule 7 by way of Special Conditions”.
Once updated, the previous versions of the CIRA templates will be archived and can be accessed here.
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:
- 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).
- 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.
- 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.