The study – which examined if ethnicity impacts the performance of Alimta as a second-line therapy for lung cancer – created some recruitment hurdles for Lilly, not least of which was the fact that, at first, just 19 per cent of enrolees were from ethnic minority groups.
To address this Lilly took steps - adding sites with large minority populations, translating patient materials into Spanish and providing assistance programmes to ensure that participation ran smoothly – and eventually ended the trial with 49 per cent of enrolees being from ethnic minorities.
Lilly spokeswoman Carla Cox told Outsouring-pharma.com that several partners – including the Acorn Network - played a key role in the process, explaining that: “They continually worked with their investigators to recruit patients and were also active in recruiting additional sites to participate.”
“We chose to partner with organizations which have the expertise in this work. We continue to work closely with those partners and advisors to aid us in our diversity strategy and implementation with initiatives across all of our clinical trials.”
Next steps
Based on this approach Lilly has developed a set of ‘culturally competent’ patient tools, including a Latino Toolkit for clinical sites designed to help investigators recruit participants from ethnic minority groups more effectively in future trial programmes.
Lilly has also sponsored advisory boards and conducted a survey of 241 clinical trial investigators and coordinators to assess the impact of protocol design on participation.
The firm said the results of this survey show that the use of ‘patient navigators’ to guide a participants through the treatment process and taking language and ethnic considerations into account when designing protocols is a must.
Coleman Obasaju, senior medical director at Lilly Oncology, said: "While the study fell short of its planned patient accrual, with only 434 of 1,000 patients enrolled, it proved that minority participation in clinical trials can increase dramatically with targeted interventions," adding that "We will apply these learnings to future trials right from the start."Lilly