For the first time, China has publicly solicited guidelines for the design of clinical trials of lysomavirus drugs.

On August 7, the Drug Review Center (CDE) of the State Drug Administration issued a notice on public consultation on the Guidelines for the Design of Clinical Trials of Soloma Virus Drugs (Draft for Comments), which mentioned that, in view of the fact that there are no relevant guidelines for the design of clinical trials of solvirus drugs in China, CDE drafted the Guidelines for the Design of Clinical Trials of Solma Virus Drugs on the basis of full investigation of the development of the same varieties at home and abroad and the technical requirements of relevant clinical trials.
lysovirus is a class of viruses that can selectively replicate and lyse tumor cells within tumor cells through different regulatory mechanisms, while minimizing the effects of normal cell growth.
the development of tumor immunotherapy, the therapeutic potential of sol tumor virus drugs in malignant tumors and other diseases has been paid more and more attention.
with the development of tumor virus drugs, it is found that these drugs have more unique consideration points in clinical trial design.
currently ICH and EMA, FDA does not have relevant technical guidelines.
time limit for soliciting opinions shall be 1 month from the date of publication.
Annex 1: Guidelines for the Design of Clinical Trials for SolomaVirus Drugs Annex 2: Guidelines for the Design of Clinical Trials for Soloma Virus Drugs (Draft for Comments) Drafting Note Annex 3: Feedback Form for the Guidelines for the Design of Clinical Trials for Melanoma Virus Drugs (Draft for Comments).