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FDA Plans Effort to Lower Costs of Clinical Trials (1)

Nov. 13, 2018, 4:47 PMUpdated: Nov. 14, 2018, 3:20 AM

The nation’s chief drug regulator wants to scale back the work of a $40 billion clinical trial outsourcing industry that he said is bloating costs without enough additional benefit.

The Food and Drug Administration will roll out a plan to decrease the burden of conducting clinical trials, FDA Commissioner Scott Gottlieb said Nov. 13. Such studies can cost as much as $22 million for an oncology trial used to approve a new drug, for example.

The goal is to “democratize the ability to conduct clinical trials,” he said. This can be achieved by expanding the reach beyond hospitals and universities to smaller sites like community health centers. This would also give more patients access to the trials.

Part of the plan would target contract research organizations like IQVIA, Syneos Health, Parexel International, and PRA Health Sciences, Gottlieb said. Drug and device companies pay these CROs to run their clinical trials. This saves them from establishing the infrastructure and hiring staff to do the work.

Business analyst companies indicate it’s a growing market. The global CRO market was $44.4 billion in 2017, according to the Business Research Company, with the U.S. taking up about a third of that market share. Another report from IGEA Hub estimated the global CRO services market at $36 billion in 2017 with expected growth to $56.3 billion by 2023.

Part of the work of CROs typically includes implementing quality assurance and quality control to ensure the data that come from the clinical trials meet internationally accepted standards of data integrity and quality.

“The QC being applied by CROs, that’s very costly and that’s not doing much to add to the overall data integrity,” Gottlieb said at a Washington Post Live event on cancer. That added layer of work is making it harder to bring clinical trials to sites like community health centers, which provide care to underserved communities. Gottlieb didn’t indicate when the plan would be released.

But Mark Barnes, a research attorney at Ropes & Gray who has set up clinical trials all over the world, said the criticism about increasing costs is not limited to CROs. Those groups are “only doing what pharma and device companies do themselves without CROs.”

Much monitoring of clinical trials, whether done by any party, CROs or industry sponsors themselves, could probably be more risk-calibrated and more efficient. For example, calibrating the level of monitoring based on the risk of the clinical trial could lead to gains in safety, Barnes said.

“But if Gottlieb is going to take this position, he should understand that this goal of ‘perfection in trial monitoring’ is very much the product of FDA’s own expectations of monitoring,” he said.

Trade Group Responds

A spokesman for the trade group representing clinical research organizations (CROs) told Bloomberg Law that Gottlieb’s comments “thoughtfully reflect how clinical trials are evolving and what a digital transformation means for the entire field of clinical research.”

The existence of CROs have led to the democratization of clinical trials by expanding their reach beyond academic medical centers to smaller community hospitals, clinics, and more, Matt Feldman of the Association of Clinical Research Organizations, said.

CROs have been “intensely engaged” with medical product sponsors to develop new, digital paradigms of oversight that supports data integrity and patient safety, he said. “The goal of these collaborations is to reduce the burden of clinical trials on patients and sites, and utilize new technology to further democratize trials,” Feldman said in a Nov. 13 email.

To contact the reporter on this story: Jeannie Baumann in Washington at jbaumann@bloomberglaw.com

To contact the editor responsible for this story: Randy Kubetin at rkubetin@bloomberglaw.com