Early this month, Chines National Medical Products Administration published guideline1 for applying real-world evidence (RWE) to support drug development as the No.1 announcement of this year. According to this guideline, RWE is to supplement the deficiencies of traditional RCT trials, for example the inability to conduct RCTs in life-threatening diseases that lack effective treatments.
WHO stated that novel coronavirus is outbreaking2, however, according to experts from Shanghai public health clinic center (SHPHC), they are trying to identify new treatment approach to meet the emergency challenge, and one possible solution may be Lopinavir/ritonavir, LPV/r. In the most updated news, a respiratory doctor received LPV/r after affected and reacted positively satisfied. SHPHC also mentioned IFN-β1b, Remdesivir, Cyclophilin inhibitors and other possible candidates, and further shared a publication list about previous research in relevant indications.
We believe that this is an opportunity for manufacturers of these products to take advantage of the newly released policy applying RWE to expand the indications in severe respiratory infections, to verify the clinical effectiveness/efficacy of these products, and to benefit infected patients and public health security.