Enhancing rural and regional access to clinical trial using the Australasian Teletrial Model (ATM): Experience from MonarchE adjuvant breast cancer trial in Queensland, Australia.

7 Background: Australasian Teletrial Model (ATM) was developed in Australia to enhance rural and regional access to clinical trials using Telehealth. Under this model, trial clusters are established by connecting smaller satellite centers with larger primary sites using telehealth; governed by standard operating procedures and streamlined approval and contractual processes recently developed by the department of health of state of Queensland. Principal Investigator oversight and roles and responsibilities of sites are documented on supervision plans. We describe the implementation of an Eli Lilly’s adjuvant breast cancer trial MonarchE using ATM in Queensland. Methods: Two larger trial sites as primary sites were linked to four smaller centres to form Northern and Goldcoast clusters. This is a descriptive study of implementation research including perspectives of clinical trial staff. Results: Between February 2018-Feb 2019, four new sites and eight new satellite staff acquired clinical trial capabilities locally. Site initiation and regular trial meetings within clusters were conducted via telehealth. 11 patients were enrolled at satellite sites. No protocol violations occurred at any of the sites including documentation and investigator product handling. Staff (six trial nurses, and 10 medical oncologists) welcomed the model for facilitating inter-site collaboration and enhancing trial access to patients. Eli Lilly incurred additional cost for conducting one-off site visits to satellites and managing medication transport to satellites. Staff spent additional time for cluster coordination and development of new processes. Conclusions: Regional sites and their staff can acquire capabilities to offer clinical trials locally using the teletrial model. Consequently, rural patients can gain access to clinical trials closer to home without needing to travel long distances. Staff welcome this model for its many benefits to patients and the system. Initial increase in set-up cost is likely to be offset by better recruitment rates. With maturity, set-up costs and time to coordinate cluster processes are likely to lessen.

Custody Disputes in the Provincial Court of Alberta: A New Judicial Dispute Resolution Model

In Alberta there is no uniform process or guideline for the application of the best interests of the child standard in custody disputes. The author asserts that in the absence of such provisions, the Provincial Court is free to develop its own process. The process for the application of the best interests of the child standard should be flexible so that each case may be treated individually, but, at the same time, follow defined standards. The author suggests that the Court must define community standards so that litigants understand the criteria used in decision-making. For many people, if the process is open and understandable then they are more likely to feel that justice has been done even in the face of an adverse result. The author addresses these process-based concerns by offering a new three stage model for custody dispute resolution. In the first stage the author suggests that details of how the child is functioning in his or her home, neighbourhood, and school should be explicitly outlined in an affidavit. The affidavit should emphasize the community values and child-centred perspective to be used by the Court. In the second, judicial dispute resolution, the author envisages a mediation that incorporates mini-trial procedure with the judge acting as an active participant in a non-adversarial context. If this fails, the presiding judge must step aside in favour of an independent judge and a regular trial will commence.

Mini-Trials in Alberta

The Alberta Court of Queen's Bench has been offering the mini-trial, a specialized dispute resolution process, to litigants and the bar for the last four years. The impetus for this move was the length and time often involved in litigation. The attraction of the mini-trial is that it is a method of expediting dispute resolution and that the costs associated with it are considerably less than those for a regular trial. The author outlines the history of the mini-trial, explaining how it developed in the U.S. as a private dispute resolution mechanism. The Alberta mini-trial is essentially an expanded pre-trial procedure, and is offered by the Court at no cost to participants. There is no rigid, formal procedure to the Alberta mini-trial, and its great strength is in fact flexibility and informality. The only requirement the Court has is that the actual parties must be present for the arguments and at the end of the mini-trial, when the judge gives his or her opinion. The author outlines the key elements of the mini-trial, as they have evolved to date, including the role of the judge and the nature of the actual process. The mini-trial has been enormously successful at encouraging settlements, which have followed or resulted from the mini-trial in over 90 percent of cases. Additionally, both counsel and clients appear to be quite pleased with the process. Despite this success, however, it should be noted that the mini-trial may not be appropriate in all cases. The author describes the types of cases to which the mini-trial both is and is not well-suited. He offers a case study, of a mini-trial over which he presided. This mini-trial was successful and led to a settlement. In closing, the author provides information to interested counsel and parties as to how and when they can access the mini-trial. The article closes with a recommendation that mini-trials always be considered as an option in lawsuits.