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Drug development outsourcing - fix, or failure?

An interesting review by the staff at the Centre for the Study of Drug Development (CSDD) looked at the success, or otherise, of strategic partnerships between drug companies and contract research organizations (CROs).

It shows a picture of mixed results. Although almost half of total development expenditure is outsourced, the deeper relationships forged in recent years have heralded major changes in the drug development process. Examples of studies quoted in the review include:

  • A study of drug companies conducted by the Avoca Group in 2012, found that 20% of companies had ended a strategic relationship with a CRO. In the same study, one-third of drug companies surveyed were dissatisfied with the performance of the CRO and almost one in two felt that the strtategic relationship would never work

  • In 2013, a study conducted by Vantage Partners found that many 'strategic relationships' were not working well and expectations and capabilities were mismatched. One-third of drug companies said that the expected cost and time-savings had not materialized, while over half said that the relationship was failing to provide innovative solutions

  • In the study by Vantage Partners, cultural barriers, poor communication, and failure to achieve organizational buy-in contributed to the problems

Further analysis by CSDD showed that there were problems relating to trust, unrealistic expectations, and fragmentation. Yet are all CROs incompetent, while sponsor companies are models of perfection. Having worked in both, I'd suggest not. Yet the problems persist.

Perhaps it's time to look not at the principle of the strategic relationship, but at the day-to-day practicalities of how to make it work. Perhaps it's time to look at the processes, tools, knowledge and expertise of the joint teams, rathert than conduct another high-level witch hunt.

If you don't send your kids to school ill equipped to succeed, why send an ill-informed CRO off to conduct your studies?

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