With DPharm 2023 on the horizon and Phesi nominated for the DPharm Idol Disrupt award, we consider the steps the industry can take to modernize clinical development and how sponsors can become a disruptive force for good.
Patient-centric data to plug diversity gaps in clinical trials
Historically, the clinical development industry has failed to truly represent all patient populations in important clinical trials. Last year, a Phesi analysis found that 48% of US cancer trials have no Hispanic or Latin American representation, and 42% do not include a single Black patient. If entire racial and ethnic groups are excluded from clinical trials in important disease areas such as oncology, there is a risk that new drugs could be less effective in these groups and there could be an increased risk of adverse effects.
With the FDA advising sponsors to recruit trial participants from diverse backgrounds and locate investigator sites in areas with higher concentrations of underrepresented patients, sponsors need to incorporate diversity at the earliest stage of protocol design. This will require a patient-centric and data-driven approach. There is already a wealth of data available to give sponsors a comprehensive view of patient cohorts, which can inform the selection of recruitment sites and minimize delays in the approval stages. Look out for more news on this area soon from Phesi.
Dynamic data from similar or identical trials, combined with real-world patient data, can even allow sponsors to produce a digital trial arm and close diversity gaps in ongoing trials. In many disease indications, sponsors can already build digital trial arms drawing on comprehensive and diverse existing datasets that are representative of all races.
Another disruptive innovation that can advance clinical development is Digital Patient Profiles (DPP). With DPPs, sponsors can gain a statistical view of patient characteristics – such as ethnicity, comorbidities, concomitant medications, and outcomes. With this deeper understanding, patient recruitment is more targeted, helping increase diversity and ensure new medicines are safe for all.
A brighter future for clinical development
As the clinical development industry begins to harness DPPs and predictive data analytics, we expect to see other disruptive and transformational use cases being applied in trial design and operations. It will be the sponsors that use existing data and patient records to design smarter and more representative trials that save money while improving patient centricity.
Come and speak to us at DPharm 2023 to discover why disruption in clinical development is vital to reduce patient burden, drive greater inclusivity, and bring better drugs to market, faster.