The Shanghai Mental Health Center (SMHC) has selected Signant Health – formerly CRF Health and Bracket – to provide electronic informed consent (eConsent) for an investigator-led Schizophrenia trial.
The randomized Sequential Therapy for Schizophrenia focusing on Optimizing Model in China (STSOM-C) study will enroll 800 patients across multiple sites. It also will be the first in China to implement Signant’s TrialConsent solution, which was initially launched by CRF Health in May 2016, and incorporates eConsent and electronic clinical outcomes assessment (eCOA) in a single platform.
Stephane Deleger, vice president of business development at Signant Health, said the sponsor will use Signant’s TrialConsent to improve the quality of informed concept forms (ICF). “This is the first eConsent pilot in China and will be of interest to India and Singapore which are also looking towards running pilot studies using this eConsent technology,” said Deleger.
“Moreover, the ground-breaking insights gained from Signant Health’s predictive data analytics and endpoint data quality solutions in neuroscience, is transferrable to other therapeutic areas such as immune-mediated and cardiorespiratory diseases, as well as oncology,” he told us.
As per demand in South East Asia, Deleger said the area is an important emerging market in clinical research, “especially China, with a very large population of tech savvy subjects and a fast-growing economy generating an increasing demand for global R&D tools and expertise.”
Since 2015, there have been several regulatory changes in China that have helped drive growth in the clinical trials market.
“Clinical research has accelerated with focus on reducing time and trial costs to facilitate discovery in Phase I studies to ultimately speed up the entry of new treatments to the market,” said Deleger.
Working with sponsors, research sites, and institutional review boards (IRBs), Deleger added that Signant’s eConsent platform, TrialConsent, provides real-time reporting, monitoring consent status at the study, site, and participant level.
Said Deleger, “With SMHC leading the vanguard digitizing eConsent in this landmark study in China, the proven benefits from global research will encourage further adoption in the Asia Pacific region, and help re-shape interactions with patients, bringing more convenient workflows, and delivering greater returns for sponsors.”