An evidence-based approach to planning during protocol development is key to successful patient recruitment according to Joseph Kim, director of clinical operations at Shire Pharmaceuticals.
Kim spoke with Outsourcing-pharma.com ahead of his presentation at Patient Recruitment Outsourcing 2011 next month and suggested that, in terms of patient recruitment, the pharmaceutical industry has not always been good at using data.
He explained that assumptions about patient populations made during protocol development can determine inclusion and exclusion criteria despite the lack of supporting data.
Instead, Kim said that drug companies need to define the benefits of a more evidence based approach, citing the high cost of protocol amendments as a useful metric. Then, he continued, they need to adopt a create approach to data collection and analysis.
CRO role and need for investment
Kim also suggested that contract research organisations (CROs) can play an important role in the protocol development process if they can successfully move from the traditional survey-based approach to feasibility to a more data-focused model.
“They [CROs] are the builder to the [pharma] architect and the architect needs to know how realistic its designs are.”
One of the hurdles CROs face in introducing this sort of initiative is that a data-focused approach requires investment which, according to Kim, contractors are sometimes reluctant to do unless such spending generated revenue.
Kim will be covering this and various other aspects of patient recruitment during his presentation at Patient recruitment Outsourcing 2011 in September. Sign up and attend this Outsourcing-pharma.com event here .