Are digital therapeutics really effective? Are they safe?
Effectiveness and safety of digital therapeutics are extremely important factors to be assessed.
The brief answer is yes, since by definition a digital therapeutic must be evidence-based.
But what define a proper evidence? And how can we be sure that a specific health claim is supported by evidence?
The gold standard for evidence generation in medicine are randomized controlled trials (RCTs). And obviously every claim must be assessed and proven. The same must be true for DTx and digital health in general.
What are randomized controlled trials?
In these clinical studies the needed results are obtained evaluating the experimental intervention comparing to a control group (undergoing placebo or another, already approved, active treatment). Clinical trial participants are subdivided between experimental or control groups randomly. Randomization prevents selection bias by distributing randomly patients’ characteristics that may influence the outcome (even the unknown ones), so that any difference can be explained only by the treatment.
This approach to demonstrate efficacy and safety remains the gold standard also for the upcoming digital therapeutics solutions.
Are clinical trials results reliable? Where could we see these results?
Every clinical study to be reliable must have a good design and must be adequately-powered in statistical terms (enough participants included). To check all these details and their ethical aspects, clinical studies are conducted only after proper authorization by institutional review boards/ethics committees.
In addition, to prevent “publication bias”, studies must be listed on a proper trial registry (centralized, searchable databases like https://clinicaltrials.gov/ or https://www.clinicaltrialsregister.eu/) prior of the beginning. Publication bias is the risk that just positive results will be published, discarding the negative ones. With official registers we can have a more comprehensive understanding on past and ongoing experimentations. In addition, wasteful repetitions are avoided and fraud and errors could also be prevented. All trial results must indeed be published on these platforms.
Another mechanism of control is peer-reviewing.
Indeed, to be considered by the international scientific community, researches must be published on reputable scientific journals. These journals, in addition to the editors’ work, use peer-reviewing to guarantee the quality of their publications. (In this process the received research is subject to the scrutiny of others who are experts in the same field)
From clinical trials to the real world
In addition to that, the Digital Therapeutics Alliance encourages conducting analysis and application of real world evidence and product performance data to optimize the product for better engagement, implementation, and adherence and ensure continued safety and effectiveness.
Indeed, every interaction with digital products may be easily tracked, informing/suggesting possible refinements able to increase users’ engagement and adoption and, thus, health outcomes.
This opportunity further increases the potential of digital therapeutics.