Case Study: Epidemiology

Objectives

To examine in a routine clinical practice setting, modalities and conditions of adjustment of doses with the 3 different recombinant human erythropoetins (EPO) treatments in relation to the evolution of biological parameters.

Scope

A retrospective, descriptive observational study including study feasibility, with a 1:1:1 patient distribution and a 3:1 solid vs liquid tumour type in the 3 different EPO treatments available. 600 patients recruited for the interim analyses and 850 patients recruited for the final analyses across France, Germany, Italy, Spain.

Challenges

• Ensuring correct data was collected to maintain ratios
• Investigator selection took more than the anticipated time and resource

Solutions

• Clear status updates and reporting which allowed decisions to be made as to which data was needed
• Additional investigator selection methods were adopted to address the shortfall in a proactive manner
• For this type of study with minimal fee involved, it was more efficient to use countries where facility agreement is not required, i.e. where PI can sign contracts directly, to avoid incurring unnecessary delays
• PACE EDC technology was used which was quick to set up and which benefits from EDC offline access

Outcome

Protocol design was done by PAREXEL who were able to guide and ensure only appropriate protocol data collection points were included using our experience in key EU countries in terms of retrospective data.