Principal investigators are often asked by their patients if they can continue to use the investigational product (IP) after the trial is over.
In pharmaceutical and some medical device trials, access to IP following the end of a trial may be a desired outcome for the patient, but not planned for within the clinical trial protocol by the sponsor. However, supply of the product may still be possible through special access pathways. This allows continued use by patients after the completion of the trial, with direct supervision by a prescribing clinician authorized by TGA.
There are 3 pathways:
Extension Clinical Trial
The sponsor may choose to create an extension trial, such that participants consent to roll into the extension trial upon completion of the initial trial. The benefits to the sponsor in this situation is collection of long-term safety and efficacy data. The extension trial, like all clinical trials, requires ethics approval and the TGA is notified through the Clinical Trial Notification (CTN) or Clinical Trial Exemption (CTX) Scheme.
Special Access Scheme (SAS)
The SAS is an arrangement which provides for the import and/or supply of an unapproved therapeutic good for a single patient, on a case by case basis. There are two categories under the SAS:
SAS Category A – This provides for a clinician in cases of emergency to use a device in advance of authorization, and to gain retrospective approval from TGA. SAS A is intended for cases where the patient is seriously ill and in imminent danger of death or serious injury if not treated promptly with the unapproved device.
SAS Category B – Requires advance approval from TGA and is used in non-emergency cases.
Essentially the application is made by the clinician and is assessed by a TGA medical officer. It’s a clinical conversation about the needs of the specific patient.
The authorised prescriber regulations provide a broader authority for a defined medical practitioner (or group of practitioners) to prescribe a specific unapproved product to specific patients who have a specific medical condition. The physician must have expertise in the medical condition being treated, be able to determine the needs of the patient, and commit to monitor the outcome of the therapy – including making adverse event reports under TGA’s IRIS scheme. This pathway is used in cases where a device may be pending regulatory review -as well as in cases of continued use post a clinical trial.
In addition to these regulated pathways, Australia also has a unique provision in its regulations for any person to import a therapeutic good (medicine or device) for their personal use even if the device is not approved for general supply in Australia. This is known as the Personal Import Scheme. Personal importation is where an individual either brings a therapeutic good into Australia on their person or arranges from within Australia for a therapeutic good to be sent to them from an overseas supplier. The criterion is goods must be used by that individual or a member of his/her immediate family, and are not sold or supplied to any other person. In this situation the individual assumes responsibility for any adverse events of the unapproved product. Personal imports are limited to sufficient goods for 3 months usage.
Special access schemes particularly provide flexibility for early supply of unapproved devices in defined circumstances of clinical need.
Want to learn more? Suzanne Williams, Principal of Mobius Medical will be presenting at the Asia Pacific Devices Summit in San Francisco, CA, March 10-11. Suzanne will lead an in-depth session on ‘Clinical Trials Down Under‘. Why not join us and meet Suzanne face to face. The summit features in-depth presentations from leading Asian experts in regulatory, reimbursement, clinical trials and much more. It’s a must attend event for anyone serious about succeeding in Asia. Don’t miss the early bird discount cutoff Register before the 14th Feb and save $495
Suzanne Williams is Principal and the Clinical Director of Mobius Medical, a boutique CRO based in Sydney, Australia. Originally from the United Kingdom and with over 20 years clinical research experience spanning Europe and the US, Suzanne has been engaged in pharma. Medical device and IVD clinical research in Australia for the last 18 years. Suzanne, along with her partners, Stefan Czyniewski and Richard Brookes at Mobius Medical particularly enjoy partnering small to medium sized companies and start-ups providing a highly personalized approach. Suzanne’s role at Mobius involves liaison with industry bodies, pharma and device companies, along with clinical investigational staff to source, design, initiate, resource and project manage a wide variety of clinical trials.