"As of March, regulatory authorities in Lithuania have mandated that all principal investigators take and pass a GCP course prior to conducting a clinical trial with any pharmaceutical company," says Michelle Metry, head of Merck's global training group. "It is one of the first countries in the region to identify a training need, and the requirements are quite specific. The local regulatory agency expects investigators to obtain a GCP certificate that includes names, place, and date of training, and signature of the sponsor or legal representative," added Metry. "A minimum of eight hours of basic training (four hours for refresher) is required, and the training organization must archive training materials for five years. But the regulation doesn't specifically say that the training needs to be provided by a pharmaceutical company."

Metry explained that Merck has recently put together a global training organization that will, among other things, begin proactively offering nonprotocol-specific functional training to investigative site personnel. "The same curriculum will be offered in the CEE and Asia Pacific regions. Training topics will be determined by feedback from staff based in countries within these regions," she said.

An east wind blows

"Wyeth has a mature clinical research and development organization, particularly in Hungary," said Sheila Ronkin, MD, assistant vice president of clinical development. "Wyeth has created a global network of 15 sites (as of July '07), including two institutions in Hungary, which have agreed to accept a portfolio of Wyeth studies—global Phase II as well as Phase III, IV, and regional trials—under one master contract," she said. "Each of these clinical partners is capable of producing 300 to 500 patients per year, sufficient volume to justify having continuous on-site monitoring. Clinical trial approval times in Hungary are also favorable, allowing trials to start within three to four months."

"At this time Wyeth primarily places studies in Hungary, as well as Poland and the Czech Republic," said Robert Maguire, MD, vice president of clinical development. "Wyeth is also doing more in the Ukraine, Bulgaria, and Russia."

"GCP compliance in the CEE was problematic before 2004. We've seen considerable improvement since then, when the European Trial Directive was published and Wyeth implemented rigorous investigative site assessments and postinitiation compliance visits," said Maguire.

"I think there's a lot of untapped potential, particularly in Russia at this time," added Maguire. "But the country presents several major challenges, including a sluggish regulatory approval process and potential GCP compliance issues. Hospitals also tend to be indication-specific, making them tough to build into a new global network. But I'm optimistic that Russia will end up being a nice place to do clinical trials. Wyeth just established a commercial office in Moscow and has plans to add R&D personnel in the region."

Compliance concerns

For the past five years, Olympia, WA-based Western Institutional Review Board (WIRB) has been partnering with the World Health Organization to build the infrastructure for ethical review in developing countries. WIRB has been providing a six-month fellowship program for mid-career physicians. Two of the 50 fellows to date have been from Eastern Europe, "but we don't do anything on the ground with them," says WIRB President Angela Bowen, MD, citing concerns about political instability and a general lack of authoritative regulatory oversight.