The Ministery of Food and Drug Safety has made the review standards for clinical trials of digital therapeutics more specific. In addition to whether statistically significant changes appear, it directed evaluators to assess whether the change is at a level patients can perceive as improvement.
The National Institute of Food and Drug Safety Evaluation (NIFDS) under the Ministery of Food and Drug Safety revised on the 10th the "guideline for preparing clinical trial protocols for digital therapeutics" for seven indications, including nicotine use disorder, alcohol use disorder, and panic disorder.
The revision reflects cases identified during the actual protocol review process after the Digital Medical Products Act took effect, as well as the latest international trends. The aim is to reduce trial and error developers face when designing clinical trials and to shorten preparation time.
The biggest change is the clarification of criteria for deciding which treatment effects to measure in clinical trials. It adds setting efficacy endpoints based on scientific evidence and defining the "minimum clinically important difference (MCID)." MCID means the minimum amount of change that patients can perceive as "feeling better."
Standards to enhance the reliability of clinical trials were also supplemented. Examples were added to reference when setting multicenter clinical trials and follow-up periods. Related items and terms were also updated to align with the Digital Medical Products Act and its subordinate regulations.
The indications covered by this guideline are seven in total: ▲ nicotine use disorder ▲ alcohol use disorder ▲ panic disorder ▲ depressive disorder ▲ eating disorder ▲ attention-deficit/hyperactivity disorder (ADHD) ▲ mild cognitive impairment.