Our ABA DrOmnibus App, launched in October 2016, is still developing and expanding its game content (the latest games, added in May, are based on photos and the new ‘Match the Pictures’ concept) and functionalities: a new layout and the ability to link the therapist’s and the parent’s accounts together to allow them to work together on the app.
In response to market demand, we have also begun preparations for a clinical trial of our app. The goal of the trial is to achieve the world’s first clinically validated and FDA– approved therapeutic application that enhances the effectiveness of behavioral therapy among children with cognitive deficits, including autism spectrum disorders.
We are working on a project of the trial with Proper Medical Writing, a company specializing in designing and coordinating clinical trials for drugs and other medical products. Proper Medical Writing’s portfolio also includes preparing the necessary documentation for CE and FDA certificates or writing and editing and translating medical texts.
We are currently working on the general draft of the trial and its concept and plan. A correct project of a clinical trial is one of its most important stages that has a considerable impact on the final success. Parameters such as the number of patients recruited for the trial, choice of population, period of observation or precise definition of trial aims (in other words, the appropriate formulation of hypotheses) are key factors needed to receive permission for the trial from the Bioethics Committee and the Office for Registration of Medicinal Products, to recruit participants and, in the end, to obtain statistically and clinically significant data that would confirm the app’s effectiveness.
During a series of meetings, the top experts in psychiatry, psychology and behavioral therapy working with a dedicated Proper Medical Writing team will decide on the shape of the planned trial.
Currently, the teams are working on the protocol, which is a formal document that defines the trial in detail and describes its course. It will become an ‘instruction manual’ for the trial once the Bioethics Committee and the Office give their approval.
The next important step will be signing an agreement with the centers at which the recruitment will take place.