As in other regulated countries,there can be no short cuts when it comes to preparing for a clinical trial in AUS. Sponsors must without a shadow of a doubt have a nonclinical IND-enabling package of studies that has been conducted according to globally accepted standards in hand prior to the initiation of clinical trials in Australia. The study data must be available and ready to provide to regulators such as the Therapeutic Goods Administration (TGA) in AUS. The TGA requirements for initiation of a clinical trial include the submission of a Clinical Trial Notification (CTN) or Clinical Trial Approval (CTA). The main difference between the CTN and CTA schemes is the TGA’s level of involvement in reviewing the package of nonclinical studies submitted.
One of the primary topics of discussion was about a 43.5% R&D cash back program, which can be applicable to your entire IND-enabling GLP Toxicology package. To learn more about that, click here! Sponsors can still qualify if portion of studies are in the US and the rest in AUS.
Attentive Science continues to support global drug development by performing GLP nonclinical safety studies for the conduct of human clinical trials for pharmaceuticals [ICH M3 (R2)], as well as those that meet ICH S3A, S4, and S7A global guidelines. Hence the “overseas findings” for the R&D incentive program can be eligible for the cash back program when working with Attentive Science and its Australian collaborators. Creation of responsibility matrices is key in ensuring that your CRO and Sponsor relationship succeeds.
Distance/time zones are obviously challenges for Sponsors working with CROs in AUS. However, this challenge can actually be an advantage as long as the Sponsor sets up clear expectations and communication strategies. For projects that Attentive Science and its collaborator Agilex Biolabs are working together on, our Sponsors actually gain a whole day in any week. Our AUS colleagues start work on their Monday, which equates to Sunday evening in the US. Your project therefore has Attentive eyes on it for nearly an additional whole day. For an industry where timelines are critical, gaining an extra day each week of work can be crucial.
The panel also had an interesting conversation about decentralized (direct to patient) clinical trials, which is clearly recognized as a hot topic in our industry. It is certainly not going to be a fit for all purposes, but teletrials are here to stay and a thing to watch out for. The patients’ needs must be kept top of mind for clinical trial enrollment and retention when considering decentralized trials.
Attentive’s collaborative efforts with our Australian colleagues ensures that study Sponsors in North America as well as the APAC region are provided another option to keep the drug development process moving at the speed in which our clients strive for. Call us to learn more.