Outsourcing-Pharma focus on: Phase IIIB-IV research

CROs to benefit from FDA's push to clear Phase IV backlog

By Kirsty Barnes

- Last updated on GMT

Related tags: Drug companies, Clinical trial

The US Food & Drug Administration's (FDA) drive to clear the
mounting backlog of post-marketing (Phase IV) drug trials signals
good news for the clinical research organisations (CROs) who are
poised to benefit.

Worryingly, 65 per cent of the Phase IV safety studies that pharma companies agree to conduct as a condition of approval of a new drug are not being completed, or are still "pending," and the FDA recently commissioned consultancy firm Booz Allen Hamilton to recommend ways of boosting the completion rate of these studies.

"This is good news for CROs, as anything that increases the focus on the completion of post-marketing studies is good for CROs,"​ Dr Hugo Stephenson, president of Strategic Research Services, Quintiles, told Outsourcing-Pharma.com.

However, Stephenson believes the result of the 12-month Booz Allen investigation will go one of two ways - the introduction of financial penalties for non-compliance; or a complete overhaul of the system - both of which will have different implications for the CROs in the Phase IV business.

The first and most likely outcome involves a recommendation to petition government legislators to allow the FDA to impose financial penalties to those companies not completing the trials within a reasonable time.

"In this scenario, CROs would experience a slight increase in the number of post-marketing studies being started, however, the impact on new business would not be huge,"​ said Stephenson.

"This is because penalties won't address the heart of the problem, which is not that drug companies aren't starting these Phase IV trials, but that they aren't completing them."

The FDA are often unrealistic with the comitment studies that they impose on drug companies, asking for a very academic study without taking into account the practicalities of the trial design or the logistics of conducting the trial, Stephenson said.

"Drug companies then run into difficulties half way through the trial and find they are unable to finish. This is a major problem with the current system,"​ he said.

Stephenson also believes that if the FDA simply imposes financial penalties for late completion, not only does this not address the problem, but could place an extra burden on CROs, who may find their contracts becoming more difficult as they are placed under increasing pressure from drug companies to complete these trials on time, even if the trial design is unworkable from the start.

According to Stephenson, a possible second, and more positive recommendation to the FDA would be to take a more open dialogue approach with drug companies and encourage them to be more proactive in coming up with a trial design that they think is reasonable, and then, before any agreement is finalised, allowing a faseability planning period of 1-2 months.

"This approach would decrease patient recruitment time and shorten the overall length of Phase IV trials. The success rate of these trials would improve dramatically to about 70 per cent,"​ said Stephenson.

"This would be the ideal outcome for CROs, as the faster CROs can burn projects, the better, as roughly the same volume of money would be spent by the drug company on each trial, but over a shorter period of time. In addition, the focus would not only be on increasing the speed of Phase IV trials and return on investment, but also on trial quality and trial outcomes,"​ he said.

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