R&D and commercial work together to design trials, says DIA

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‘CROs: look at the entire portfolio, not just the individual project, when planning clinical studies,’ says DIA’s adaptive design scientific working group.

Speaking to Outsourcing-Pharma at this year’s DIA Euromeeting in Denmark, Quintiles’ Zoran Antonijevic – a member of the Drug Information Association’s (DIA) working group – called for a change in paradigm in trial design with decisions at the portfolio level.

He said that by having such segregated R&D (research and development) and commercial teams, CROs (contract research organisations) are blinkered, and cannot achieve an optimal product portfolio.

Antonijevic, senior director of the centre for statistics in drug development and innovation in the US for Quintiles, said: “A narrow look at the individual programs outside of the context of what else is going on in the company is just not the optimal way to go.”

The entire reason companies are making bigger decisions at proof of concept stage, he said, is to free up resources to invest in other studies.

He added: “In order to know what our optimal decision is, we need to know what else we have in the pipeline. We need to look at this more broadly.

“The key is that companies accept this is drug and portfolio development.”

News for Quintiles?

When asked whether Quintiles might offer services in the future to support this kind of development, Antonijevic replied: Absolutely. We have thought leaders, and resources to invest in this.”

However it seems the only hold-up is getting industry to catch-on.

“It’s really a matter of this concept being accepted by the pharmaceutical industry,” he said.

But the future seems bright for the concept; Antonijevic added that he believes this kind of service will hit the market as soon as in the next two years.

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