Peter O'Donnell
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By the time you read this, transatlantic cooperation on Good Clinical Practice will have passed a new milestone. As from September
1, 2009, the European Medicines Agency (EMEA) and the US Food and Drug Administration (FDA) will have launched their joint
initiative to collaborate on international Good Clinical Practice (GCP) inspection activities. The two sides will share information
on inspection planning, policy and outcomes, and on the conduct of collaborative inspections.
The justification for this innovation is that it will help protect clinical trial subjects in the face of increasingly globalized
clinical research. As the EMEA says, in defense of the scheme, "in most cases" the same clinical trials are used to support
marketing authorization applications in the European Union and new drug applications and biologics license applications in
the United States.
The scheme has become possible because of confidentiality arrangements that have been established recently between the EU
and the FDA. It will look at GCP-related information contained in applications for scientific advice, orphan medicines designation,
pediatric investigational plans, and marketing authorization or postauthorization activities of significant public health
interest.
Thomas Lönngren, the EMEA's executive director, speaks warmly of "the increasing collaboration" between his agency and the
FDA. He sees this latest move as "an important step to the building of a global regulatory network for supervision of clinical
trials." In any case, limited inspection resources mean that "only a sample of sites and clinical studies can be inspected." So on
a more empirical and local level, the cooperation should certainly save some time and energy, or, as Lönngren puts it: "By
working together in a collaborative and synergistic manner, GCP inspection resources can be used more efficiently." Notably,
the exchanges should make the selection of studies and sites "well informed."
The initiative has been started with an 18-month pilot phase, which will focus only on products regulated by the Center for
Drug Evaluation and Research in the United States and by the EMEA for the centralized procedure. But over time what is envisaged
is the periodic exchange of GCP-related information, collaborative inspections, and systematic mutual alerts on GCP-related
legislation, regulatory guidance, and related documents.
The results expected by the authorities will be streamlined inspection planning, faster and more effective communication of
inspection outcomes, alignment of inspection procedures, and, over time, a closer sharing of interpretation of GCP, allowing
the two sides to "act together to benefit the clinical research process." The cooperation is, says the EMEA, designed to build
mutual understanding of, and confidence in, the GCP inspection processes. Trial sponsors can help too, says the EMEA, by informing
regulators in the United States and EU of a joint filing, which can be coordinated in both regions.
Anyone conducting a clinical trial who is curious to know more about how this is going to work can get real close to the action.
The EMEA and FDA are inviting volunteers to participate in a collaborative inspection during the pilot phase. The opportunity
is there to sign up "to engage in dialogue and planning of joint inspections involving applications that are anticipated to
be submitted fairly simultaneously to both agencies within the next 12 months."
