Phesi, a global provider of patient-centric data software and services, has partnered with Krystelis, a provider of medical writing and clinical trial transparency services, to launch its new Diversity, Equity, and Inclusion (DEI) Data Service.
A 2022 Phesi data analysis discovered 42% of US cancer trial cohorts do not include African American patients, and almost half – 48% – have no Hispanic American patients. In a further 2023 analysis on a subset of data from 22.4 million patients, Phesi discovered only 10.2 million female patients, meaning 45% of data were collected from women.
The new service harnesses data from Phesi, and uses Krystelis’ writing services to empower sponsors to improve diversity from the trial planning stage onwards. Enabling sponsors to minimise costly protocol amendments (at an average cost of $500,000/amendment) and to meet new global DEI rules from regulators including the FDA – ensuring any therapeutic is efficacious for all intended patient populations.
“Our new DEI Data Service was born of a real need for a more innovative solution to address the lack of diversity in clinical trials,” said Dr Gen Li, founder and CEO of Phesi. “Without diverse patient cohorts that accurately reflect the patient population a drug is intended for, we cannot ensure that drugs will be fully safe or effective. It’s clear the industry needs a new approach to deliver more equitable treatments, and our partnership with Krystelis will deliver this. The new service is the latest in our steps to disrupt clinical development and will enable clients to develop smarter trials and deliver faster cures.”
Dr Pooja Phogat, co-founder and co-CEO of Krystelis, said: “The new service will make the development process easier for sponsors and help them to ensure they are meeting new, more stringent, regulatory requirements. It also has the potential to save sponsors millions of dollars and months of time, enabling them to bring more effective drugs to market, faster.”
Otis Johnson, Principal Consultant, Trial Equity, said: “With the FDA issuing guidance to address failings in clinical trial diversity, sponsors are under increasing pressure to improve protocol design. It’s great to see companies like Phesi and Krystelis delivering practical solutions and services to help companies meet these new regulations quickly and effectively. Using data to improve inclusion in clinical trials brings us a step closer to a clinical development industry that benefits all patients.”