Partnering for Good Clinical Practices

The European Medicines Agency (EMEA) and the U.S. FDA are working together to ensure that clinical trials submitted in drug marketing applications in the United States and in Europe are conducted uniformly, appropriately, and ethically, the two agencies reported this month. The Good Clinical Practices (GCP) Initiative begins in September 2009 with an 18-month pilot program for inspecting clinical trial sites and studies.

The global nature of today’s clinical trials makes inspection and oversight a challenge, especially given limited agency budgets. The EMEA-FDA GCP initiative will allow the two agencies to share relevant data to improve inspection coverage and to report the outcomes of those inspections, while still operating within the framework of the confidentiality arrangements established between the European Commission, the EMEA, and the U.S. FDA.

Best practices will be shared, as will EMEA and FDA interpretations of Good Clinical Practices. For instance, strict controls must be in place for clinical drug packaging and labeling processes. Drugs must be packaged and labeled for complete traceability, yet without identifying characteristics that could create bias during the study. Many companies are also employing compliance packaging, even smart packaging with electronic tracking sensors and diaries, to encourage adherence to study regimens. Innovations in clinical trial packaging will be discussed at the upcoming Pharmapack 2010. For details, visit http://www.pharmapack.com.fr/.

At the end of the GCP 18-month initial pilot, the agencies will assess its effectiveness and plan the next phase of the initiative.

“This is another initiative that will further strengthen the very robust relationship between the FDA and the EMEA,” said Murray M. Lumpkin, M.D, Deputy Commissioner for the U.S. FDA’s International Programs. “This will allow both the FDA and the EMEA to leverage each other's GCP inspectional resources so both of us can use our resources to assure more of the clinical trials submitted to both agencies are of the highest quality.”

Pharmaceuticals regulated by the EMEA for the European Union and by the U.S. FDA’s Center for Drug Evaluation and Research in the United States will be the focus of the initiative.

The European Forum for Good Clinical Practice (EFGCP; http://www.efgcp.be/) continues to encourage good clinical practice in all stages of biomedical research throughout Europe. The group is planning a workshop in November 2009, “EFGCP Geriatric Medicines Working Party Workshop,” which will address the needs of older patients, many of whom are excluded from medical research for existing health conditions. “The aging process produces its own specific pathological states and diseases which can only be studied in these populations,” EFGCP writes. “The older participant may also be particularly vulnerable in a number of ways, which may preclude autonomy and dignity thus limiting inclusion in clinical trials and access to the benefits of medical research.”

To read details on Good Clinical Practices from the International Conference on Harmonization, click here. For the U.S. FDA’s documents pertaining to GCP, click here.

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