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Data-backed decisions ease enrollment, PRO panelists say

By Nick Taylor , 27-Sep-2011

Clinical trial enrollment can be accelerated by better understanding patients and using EHRs to inform protocol design, panelists told an Outsourcing-Pharma conference.

On Monday biopharm companies, contract research organisations (CROs) and patient enrollment agencies gathered in Boston, Massachusetts for Patient Recruitment Outsourcing 2011.

Christopher Sleat, chief marketing officer at Inclinix, kicked off the event by discussing the value of in-field enrollment teams. Placing a member of staff at a trial site can increase enrollment fourfold, Sleat said, by boosting the likelihood that patients visiting the centre are recruited into the study.

In a wide-ranging question and answer session following the presentation attendees queried how receptive sites are to having another person taking up their time. Sleat said sites will embrace the model when it helps them and the onus is on the in-field recruitment agent to provide value to the healthcare providers.

The model proposed by Sleat makes sure fewer patients visiting a site slip through the net. John Needham, global strategist at Patient Recruitment Strategy, looked at a different part of the enrollment challenge – informing people about a clinical trial.

Assume nothing about patients”, Needham said. Mistakes are made when marketing strategies to inform people about a clinical trial are designed without a sound understanding of the attitudes and emotions of the patient population. Needham advocated conducting online surveys to gain this knowledge.

Sponsors must also understand their vendors, Rikke Winther, divisional director, outsourcing management at H Lundbeck, said. When sponsors and CROs act as one company, are transparent with and share knowledge and expertise patient recruitment is more effective, but implementing this idea is challenging.

The fact is we're not one company”, Winther said. Sponsors and CROs have different goals but by engaging vendors and discussing the clinical trial better results can be achieved.

Joseph Kim, director of clinical operations at Shire, moved further back in the clinical trial process to discuss how better designed protocols can increase enrollment. Using data, such as electronic health records (EHR), to inform protocol design can help companies identify potential recruitment bottlenecks and plan accordingly.

Selling the need for upfront investment to management has been relatively easy, Kim said, as the costs are covered by eliminating even one amendment to the protocol. Recent research from Tufts Center for the Study of Drug Development found that clinical trial protocols are amended 2.3 times on average.

Outsourcing-Pharma will take a closer look at individual sessions, and discussions from the second day, in the coming week.

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