Embattled biotech Karyopharm is looking to move past its recent trial setbacks, penning an expansion to its original 2014 partnership on machine-learning tech and risk-based monitoring techniques for its cancer tests.
It had been using Medidata’s Clinical Cloud platform for the past 3 years, but will now also start using its CSA (Centralized Statistical Analytics) and TSDV (Targeted Source Document Verification) services to help out with its data review process, as well as incorporating modern risk assessment practices into its drug development programs. No financial details of the boosted pact were given.
Ran Frenkel, chief development operations officer at Karyopharm, said: “As we advance our most promising cancer therapies, it is vital that Karyopharm embraces the latest technologies and evolving trends in the clinical trials space. Adopting Medidata’s machine-learning capabilities for centralized monitoring will not only put us in line with the updated ICH E6 R2 guidelines, but will also allow us to view clinical information at a more holistic level, better prioritize trial resources, and maintain data quality and integrity.”
The expanded pact comes amid some trial setbacks for Karyopharm this year, which a month ago saw a phase 2 trial of its big hope candidate selinexor in patients with acute myeloid leukemia deemed destined to fail during an interim analysis. The trial will keep going, but is set to miss its overall survival target.
And just two weeks later, in mid-March, Karyopharm saw all studies for selinexor placed on a partial clinical hold, meaning it can no longer recruit new patients, over the FDA’s demands for more safety details.
The company insisted that this was all down to paperwork errors; and it proved a blip, as just last week the FDA swiftly lifted its halt, although it left lingering questions over how well it was dealing with its trial paperwork.