Added 'Symptom Improvement' to COVID-19 Treatment Efficacy Criteria

Introducing 'Adaptive Design' Undergoing Mid-Term Analysis in IDMC

Food and Drug Safety Ministry CI (Photo by Food and Drug Safety Ministry)

[Asia Economy Reporter Lee Chun-hee] The Ministry of Food and Drug Safety announced on the 5th that it has published and distributed the ‘Clinical Trial Guidelines for COVID-19 Antiviral Therapeutics Targeting Mild to Moderate Cases,’ which includes content such as adding symptom improvement effects as clinical evaluation indicators in addition to severe prevention effects, to support the rapid development of COVID-19 antiviral therapeutics.

This guideline was prepared to actively promote the ‘Establishment of a Rapid Clinical Support Platform’ to support the development of COVID-19 vaccines and therapeutics, one of the ‘Top 100 Regulatory Innovation Tasks for Food and Drug’ announced last August.

The main content is the addition of new clinical evaluation indicators for clinical trials of therapeutics targeting mild to moderate COVID-19 patients. The existing clinical evaluation indicator was the prevention of severe cases. However, as the number of severe patients has decreased due to additional COVID-19 vaccinations, difficulties in conducting clinical trials have arisen, and it was deemed inevitable to set new indicators that reflect the current status of the COVID-19 infectious disease, leading to the addition of symptom improvement effects as a new evaluation indicator.

Additionally, the guidelines allow for the introduction of an adaptive design that enables appropriate changes to the number of trial subjects based on interim analysis results when preparing clinical trial protocols. This involves forming an Independent Data Monitoring Committee (IDMC) composed of independent experts to review interim results and recommend clinical modifications, continuation, or termination. Accordingly, if clinical trial protocols are approved in advance, the trial can proceed without additional approval for protocol changes, which is expected to help shorten the duration.

Furthermore, considering that the clinical trials involve infectious patients, the Ministry of Food and Drug Safety added guidance on key considerations and examples for conducting remote clinical trials.

This content was produced with the assistance of AI translation services.