The 2011 Partnerships in Clinical Trials Executive Summary is a richly detailed document for any clinical trial industry professional. In-depth notes taken directly from the 20th Annual Partnerships in Clinical Trials event are available at your fingertips. This week, we highlight the portion reviewing "Reducing Micro-Management of CROs while Maintaining Effective Quality Oversight." In this presnetation, executives from high profile Pharma companies, including Peter Carberry, MD, Senior Vice President, Global Development Operations, Astellas, Wayne Langlois, Vice President and General Manager, Global Clinical Development, Covance, and John Oidtman, VP, Clinical Operations, Emerging Markets, Pfizer discuss the findnigs of the most recent Avoca Gropu Survey, which examines the state of the clinical trial industry and it's key players. Take some time to look at last year's key takeaways and information as we gear up for the March Partnerships in Clinical Trials Event.
Download the executive summary here.
Here is a portion of this featured session from the panel discussion:
Building on the topic, Leuchten asked Oidtman for his take on globalization with regard to quality.
Oidtman: “When I think about quality and globalization, I really target two things: infrastructure and incentives. The first one is something that your organization should be thinking about very seriously: How do you build the infrastructure to support your portfolio in the countries where you want to operate?”
Oidtman noted that results from Avoca’s survey indicated that the countries with the greatest growth opportunities—emerging markets like China, for example—are
also the regions where respondents have the least comfort when it comes to quality. “At Pfizer, infrastructure involves finding ways to increase clinical research understanding and expertise and the ethics that go with it. And then how do we develop sites?”
For instance, Oidtman said Pfizer has worked with the Steve Biko Foundation in Africa—which, according to the data Avoca presented, is the region with the lowest trial quality comfort level—to educate new investigators on how they can run clinical trials ethically. “And the responses we got were, ‘Wow, I didn’t realize you (pharmaceutical companies) are in this with us to develop molecules.’ Up to that point, they had thought of us as the bad guys,” said Oidtman.
Oidtman emphasized that Pfizer is keen on site strategy: Distinguish and prioritize sites that deliver a large number of valuable patients; jettison those that don’t. “We’re seeing a lot of that in emerging markets. So building relationships with sites that you want to target and that will support the portfolio you have is key.