Insight: Managing a Global Clinical Trial

June 1, 2010
Lisa Henderson

Lisa Henderson is Editor-in-Chief of Applied Clinical Trials and Pharm Exec. She can be reached at lhenderson@mmhgroup.com.

Applied Clinical Trials

Currently, over 13,000 trials are being conducted in the larger Asian Pacific market, which includes Australia and Japan. South and Central America feature 4,000 clinical trials in place on clinicaltrials.gov. Factor in another emerging region in Eastern and Central Europe, along with the old standbys, United States and Western Europe, and there’s no mistaking everyone could use insight into the globalization of clinical trials.

To provide that insight, Medidata Solutions Worldwide has put together an interesting panel for the DIA session to be held Monday, June 14 at 1:30 to 3:30 pm. Under the Clinical Research and Development/Clinical Supplies track, “Cracking the Globalization Code: How to Do It Smarter, Faster, Better While Conforming to Evolving Regulatory Framework,” features three different sponsors presenting three different models of conducting a global trial.

Sondra Pepe, Client Relations Specialist, Medidata Solutions Worldwide, and session chairperson, spoke to Applied Clinical Trials about the session. “The attendees will receive and understand the setup and management of specific company approaches and how they do that within the global regulatory framework,” said Pepe. “The presenters are going to provide actual examples; hurdles that they have had to overcome.”

The session was designed to be interactive. Each of the three presenters will speak on their model for 20 minutes. From there, the audience will have the chance to ask questions. Pepe is anticipating the audience will be from a cross-section of companies, to complement the panel. The presenters include: Colleen A. Cook, Senior Manager, Vendor Management, for Mitsubishi Tanabe Pharma Development America Inc.; William Candela, MBA, Director, Contract and Grants Management, Bristol-Myers Squibb; and Dex Bilkic, Manager, Contracts and Budgets, Boehringer Ingelheim, Canada. The globalization approaches that they will present are, respectively, using a CRO, regional hub, and centralized operation negotiated outward.

Even with the different models, Pepe said, “In every approach, they do utilize some local knowledge. Even if you are outsourcing, there needs to be some level of local experience. The centralized model has to communicate and be able to overcome those hurdles on a local level. It all comes down to local knowledge.”

Even with the myriad of regulatory authorities and different clinical research regulations on regional and local levels--Candela’s case study will include examples from Brazil--the common theme is creating and maintaining local connections, even in regulatory, according to Pepe.

Another commonality? All of the speakers manage global budgets and have a view of trials conducted internationally. In Pepe’s role as Client Relations Specialist for Medidata, she primarily deals with the budgeting requirements for their clients. From her vantage point, Pepe notes the complexity for the person in charge of global trial budgets and contracts includes changes in standard of care and what is being covered by third party payers. “Yes, we have that in the United States,” noted Pepe. “But in other countries, clinical trial payments are excluded from third party payments.” Again in the local payment structures, “It is absolutely local expertise that helps them with that.”

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