Phesi, that provides patient-centric data software and services partnered with Krystelis – a provider of medical writing and clinical trial transparency services earlier this month (September 13).
A new diversity, equity and inclusion (DEI) data service will be launched. The service uses data from Phesi Trial Accelerator and Krystelis’ writing services to empower sponsors to improve diversity from the trial planning stage onwards.
The DEI data service, the companies say will enable sponsor to minimize costly protocol amendments (at an average cost of $500,000 per amendment) and to meet new global data DEI rules from regulators, including the US Food and Drug Administration (FDA) ensuring any therapeutic is efficacious for the intended patient populations.
Phesi says its Trial Accelerator is built on data from 90,000 dynamically updated sources, including more than 4,000 disease indications and 70.8 million patients, with detailed data about the race and/or ethnicity of 25.9 million patients.
African Americans not inlcuded in 42% of US cancer trial cohorts
Krystelis says that it provides powerful medical writing capabilities that can deliver diversity-led protocol writing as well as integrated development plans and DEI plans. 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.
Gen Li, founder and CEO of Phesi said: “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.
“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.”
Sponsors can 'embed diversity'
Krystelis’ says its expertise in medical writing services allows sponsors to embed diversity from the planning stage onwards, whether drafting protocols, applications for a new trial, regulatory documents, or applications to market a drug.
The DEI Data Service also leverages Phesi’s digital patient profiles (DPP); each DPP provides a statistical view of patient attributes for a given disease, and provides a granular breakdown of the patient population, including attributes such as age, sex, ethnicity, and comorbidities, among many other key variables.
This insight enables sponsors to identify if a disease has a higher incidence in a particular patient population. For example, prostate cancer (one of the top five most studied disease areas in 2023 to date) has a significantly higher incidence and mortality rate in black men than in white men – which should be reflected in patient cohorts.
Potential to save millions of dollars and months of time
“We are pleased to partner with Phesi to bring greater innovation to the issue of diversity in clinical trials,” Pooja Phogat, co-founder and co-CEO of Krystelis.
“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.”
On the launch of the DEI Data Service was Otis Johnson, principal consultant at 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.”