Risk-based, centralised trial monitoring wanted by FDA

By Nick Taylor

- Last updated on GMT

The FDA is encouraging sponsors to use innovative approaches to lessen reliance on on-site trial monitoring in draft guidance.

Advances in technology could allow sponsors to monitor clinical trial quality without the need to visit sites frequently, and the US Food and Drug Administration (FDA) has published draft guidance​ to encourage the shift.

FDA encourages greater reliance on centralised monitoring practices than has been the case historically​”, the agency wrote. Reflecting advances since 1996, the draft places greater emphasis on centralised monitoring approaches than ICH (International Conference on Harmonisation) E6.

Flexibility described in ICH E6 seems to support innovative approaches to monitoring, the FDA concluded. In the guidance two innovations are singled out: electronic data capture (EDC); and uses of statistical assessments to find trial sites that need extra training or monitoring are innovations.

The extent to which centralised monitoring is used will depend, to some extent, on access to EDC systems and electronic records. For example, use of an EDC system capable of assessing quality metrics in real-time could help monitors find high-risk trial sites that need close attention.

Centralised transition

When moving to a more centralised monitoring system sponsors should define processes for site record keeping, data entry and reporting to ensure timely access to data and documents. Even after taking these steps it may be wise to perform some on-site monitoring.

If a sponsor intends to rely heavily on centralised monitoring practices, it may still be advisable to conduct at least one on-site monitoring visit per site, preferably early in the conduct of the study, to evaluate site processes and controls for provision of data and source documents​”, the FDA wrote.

For now the FDA predicts on-site monitoring will continue. “We expect that the pharmaceutical and device industries will, for the foreseeable future, continue to use some amount of on-site monitoring​”, the FDA wrote.

Whatever approach is taken should be documented in a monitoring plan. “All sponsor and CRO (contract research organisation) personnel who may be involved with monitoring…should review the plan​”, the FDA wrote.

Transferring to CROs

In a subsection of the guidance the FDA covers transferring monitoring responsibility to a CRO. Sponsors retain responsibility for oversight of work done by the CRO and, as the FDA told Outsourcing-Pharma​, the obligations of transfer should be clearly stated in writing.

A sponsor has to indicate what specific responsibilities they’re transferring to the CRO in writing. Anything that’s not specifically described in writing is deemed to be retained by the sponsor​”, Ann Meeker O’Connell, acting associate director at the FDA, told Outsourcing-Pharma​.

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1 comment

New guideance

Posted by Howard Pinsky,

Thanks for bringing this to my attention.

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