From the President and CEO: Shift from Helsinki to ICH-GCP Leads to Single World Standard

The Food and Drug Administration (FDA) now allows foreign research sites and the sponsors of the studies conducted in those sites to follow good clinical practice (GCP):

“Accept as support for an IND (Investigational New Drug) or application for marketing approval a well-designed, well-conducted, non-IND foreign clinical study, if it was conducted in accordance with GCP and we are able to validate the data from the study through an onsite inspection, if necessary.”1

In April 2009, FDA replaced the requirement that such studies be conducted in accordance with the Declaration of Helsinki— principally a document of ethical principles rather than performance standards—with a requirement that the studies be conducted in accordance with GCP, approved by FDA in fiscal 2008 contained data from trials conducted outside the U.S., according to the report. More than half of all research participants and research sites were in foreign countries.

Many drug and device manufacturers conducting multiregional clinical trials have been following21 CFR Part 312.120, it stated that the standard of GCP in the revised regulation was consistent with that in ICH-GCP (E6) and was sufficiently flexible to accommodate differences in how countries regulate the conduct of clinical research while helping to ensure adequate and comparable protection of research participants.

ICH-GCP (E6) incorporates the principles of the Declaration of Helsinki into its guideline. In addition, it defines GCP as “an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects.”

The guideline states, “Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.”2

Regulators and industry

ICH brings together regulatory authorities and experts from the pharmaceutical industry to discuss scientific and technical aspects of product registration.

However, unlike the general principles outlined in the Declaration of Helsinki, ICH-GCP provides more detailed operational guidance and has been adopted as a unified standard worldwide. Any country that adopts the guideline follows the same standard.

The purpose of ICH-GCP is to achieve greater harmonization in the interpretation and application of technical guidelines and requirements for product registration, in order to reduce the number of tests or avoid the need to duplicate tests carried out during the research and development of new medicines.

Harmonization more economical

Harmonization is a more economical use of human resources, and it eliminates unnecessary delay in the global development and availability of new medicines by maintaining safeguards on quality, safety, and efficacy and by satisfying regulatory obligations. In fact, ICH-GCP (E6) is now the primary guideline for conducting multinational clinical trials and has provided impetus for the global expansion of industry-sponsored studies.

In order to foster one standard worldwide, AAHRPP accredits human research protection programs to the ICH-GCP (E6) guideline, in addition to local laws, worldwide. Dr. Peter Vasilenko, Vice President of Accreditation at AAHRPP, discusses how to apply the guideline in his column on Page 3.

While some have criticized the use of foreign trials to support marketing applications in the U.S., the fact is that of all the clinical trials sponsored by U.S. and European companies, most are still conducted in the U.S. and Europe. Still, trials are migrating to emerging markets, and that trend is unlikely to change (see accompanying article on Page 1). Thus, it is imperative that those clinical trials are conducted under high ethical standards that build public trust in the research enterprise around the world.

— Marjorie A. Speers, Ph.D.

1 21 CFR 312.120.

2 U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER) Guidance for Industry, “E6 Good Clinical Practice: Consolidated Guidance,” April 1996, p. 6.