By Ann Neuer
July 20, 2009 | At last month’s DIA annual meeting in San Diego, I set out in search of the latest trends in the biopharmaceutical industry. To find out what’s happening in the various sectors we cover in eCliniqua, I interviewed myriad attendees, exhibitors, and speakers as I floated around the San Diego Convention Center. My hands were usually full during this exercise, as I was often holding a cup of the excellent steamed chai from the ERT booth in one hand while taking notes with the other.
One of the most interesting trends I saw this year is the growing awareness of the role of the investigative site in successful clinical trial operations. The site is the end user of clinical trial technology, hence the need to better understand how it operates if its performance is to improve. Newly released versions of electronic data capture (EDC) tools boast simplicity as the best way to engage sites in collaborative efforts with sponsors and contract research organizations (CROs) seeking better performance.
There is a growing use of standards for data collection, and more emphasis on data integration across the enterprise, safety issues, and of course, more globalization. The most visible example was the India Pavilion, sponsored by the Federation of Indian Chambers of Commerce and Industry, a topic we will return to in an upcoming issue of eCliniqua.
Carmen Gonzalez, Manager of Strategy and Communications, Healthcare Communications Group, makes a noteworthy observation when she says: “What wasn’t present this year is the growing impact of social media. We know the patients are there, but we need some guideposts so we can do a good job using social media.”
Other snatches of wisdom from DIA 2009 follow:
Making Sites More Successful
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| Steve Powell |
Steve Powell (Senior VP Worldwide Sales/GM International Operations, Phase Forward): “Everyone is battling for the investigator space. The simpler you make it for them, the more beneficial it is for the sponsor running a trial.”
Martin Young (VP Corporate Development and Marketing, Phase Forward): “There’s definitely a lot of pressure on users, both sites and sponsors, so there’s a change in the user paradigm. Because sites used to use systems such as EDC once a week, for example, and now they use it everyday, the pressure is on what they need to do and how the system has to support them.”
Beth Harper (President, Clinical Performance Partners): “There is such a need for communication and information exchange with the sites. They need more information about the protocol upfront to do the right feasibility planning and recruitment planning. They also need more feedback on their performance during the study instead of waiting until the end of the study to hear from the sponsor. Sites want report cards and more transparent communication on how they are doing.”
Joseph Dustin (Business Consultant, Medidata): “It’s all about the end user. Happy sites mean happy sponsors! Now we have companies with communications pathways in place, using standards.”
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| Beth Harper |
Growing Emphasis on Standards
Terek Peterson (Director of Clinical Programming, Octagon Research Solutions): “There is a stabilization of CDISC standards—including SDTM (Study Data Tabulation Model) and ADaM (Analysis Data Model). Some companies are somewhat resistant to adopting standards as it is disruptive to their process, but after years of talking about it, people are adopting standards.”Jim Sockler (Manager Statistical Operations and Programming, Datapharm, Australia): “The trend for data managers is increasing regulation because of the introduction of CDISC standards. With ADaM, we can draw variables from multiple domains and perform the analysis.”
Adverse Events and Safety
Michael Ibara (Head of Pharmacovigilance Information Management, Pfizer): “The ASTER study is a pilot study of 30 doctors at Brigham and Women’s Hospital using a new model for capturing and reporting adverse events (AEs) to the Food and Drug Administration (FDA). ASTER uses electronic prepopulated forms that take less than one minute to complete, and doctors in the study, many of whom have never reported AEs, are reporting them with these easy-to-use forms. The first phase of the pilot is about finished. Once you digitize the data, so many things are possible.”
Data Across the Enterprise
Stephen Bergson (Executive VP, Commercial Operations, Virtify): “We are announcing the upcoming release of Virtx, an integrated software suite that is an end-to-end, Web-based solution for managing content across the enterprise. Enterprise-content compliance allows you to go from R&D or pre-clinical, to the point where you can begin to develop the dossier. You can take elements from the dossier and begin to fill out the label for structured product labeling. You can automatically bring that information into your electronic common technical document (eCTD) publishing. Enterprise content compliance accelerates, reduces costs, and mitigates risk.”
More Globalization and Economic Impact
Carmen Gonzalez (Manager of Strategy and Communications, Healthcare Communications Group): “It’s clear that there is a focus on emerging markets. When it comes to patient recruitment and retention, you have to consider ex-U.S. now. In looking at the overview of the presentations, there is a focus on India, Japan, and Asia, more broadly.”
Dan McDonald (VP, Business Strategy, Excel Life Sciences, a U.S.-based India-focused SMO): “With globalization, companies are becoming more realistic about what the expectation should be in an emerging market. Also, we’re going to see more CRO market consolidation and more mergers and acquisitions as there will be those who can’t stomach the current economic climate. There are now about 170 CROs in India, a country that has been a player for about ten years, and there is no way they can all survive.”