ALYND (A Leading Yonsei Network for Biopharmaceutical R&D), an R&D consulting center under Yonsei University Health System, said it would conduct a synthetic control arm (SCA) study on adult acute lymphoblastic leukemia, jointly with the National Institute of Food and Drug Safety Evaluation’s toxicity evaluation research division.

An SCA study refers to reconstructing patient data to fit the clinical trial conditions and purposes by using actual data collected from electronic medical records and health insurance claims.

A randomized, controlled trial is mainly used to investigate a new treatment’s efficacy and safety.

However, it is difficult to conduct clinical trials involving rare diseases, cancer patients, and pediatric patients because there is a small number of patients, or placebo administration could cause unethical problems.

On the other hand, an SCA trial can reconstruct patient data to resolve this issue. By solving unethical issues, an SCA study can broaden research areas and reduce costs for patient enrollment, testing, and drug administration.

The upcoming study will compare the results of a local trial in adult acute lymphoblastic leukemia patients treated with anticancer therapy to the outcomes of an overseas study in patients treated with Blincyto. The upcoming SCA study will be the nation’s first to use actual data from medical institutions.

ALYND said it planned to verify the validity of the study outcomes through multidisciplinary advisory from the Severance Hospital’s Hematology Department.

Shim Jae-yong, director of ALYND, said with the start of the SCA study on adult acute lymphoblastic leukemia, ALYND will be able to verify the efficacy and safety of various disease treatments through SCA trials.

ALYND specializes in supporting company-led R&D. Since the foundation in 2018, it has been operating SALT PLUS, a consulting program using medical institutions’ resources and cooperation among the industry, academia, and hospitals.