By Daniel Limbach Letter from the Editor VIEW on Clinical Services June 2006 Any mature industry would be pleased to have a double-digit annual growth trajectory for a year or two. Kalorama analysts predict that during the next five years, the growth of contract drug development will maintain a rate of 17%, which will translate into a $42 billion market by 2010. Experts interviewed for this month’s Forum backed up this prediction, stating they expect to conduct more clinical trials and outsource more of the tasks to partners. One big factor driving this growth is the globalization of clinical trials. A PharmaVOICE survey revealed that 84% of drug companies now conduct clinical trials outside the United States. According to our respondents, the best opportunities for trials are in India, Eastern Europe, Russia/Ukraine, China, and Latin America. Drug companies are carefully choosing which services they outsource, keeping their core competencies safely inside corporate walls. The most common outsourced services are monitoring, trial management, site recruitment, patient recruitment, and data management. Protocol design, on the other hand, is rarely outsourced. Technology is making greater strides in the clinical spectrum. Companies are turning to tools such as IVRS, ePRO, and EDC to run their trials more efficiently and more accurately. IVRS helps companies achieve better randomization, enrollment, and clinical-supply management. EDC tools help capture and store numerous types of study-related documents. Patients participating in a trial can now document their experiences using PDAs and e-diaries instead of paper-based diaries. Our experts in this month’s Forum recognize the value of these types of tools. They stress, however, that the technologies must facilitate and improve the sharing of information between the various clinical-trial stakeholders. Information integration is one area that helps streamline the clinical process and ensures the project meets its timeline; and time is definitely money in this business. Cutting Edge Information reports that each day a clinical trial is delayed could cost a drug company between $600,000 and $8 million. As the number of clinical trials continues to increase, delays in getting a drug to market will be compounded. As such, choosing the right outsourcing partner has never been more important. Our Forum experts look for established companies with specific knowledge in a therapeutic class and in the types of functions sought. Outsourcing partners also are expected to have expertise in areas such as project management, protocol execution, and record keeping. For sponsors, a strong track record with similar trials is a leading indicator of how well CROs can handle a new trial. Drug companies want to know that their partners can adapt to unexpected events and have the bench strength to maintain the timeline even in cases of staff turnover and other events. They expect their partners to understand the regulatory environment and respect the company’s requirements. Many of the themes discussed in this Forum will be reflected in the 350 sessions and 40 tutorials led by more than 1,000 speakers at this year’s annual Drug Information Association (DIA) meeting in Philadelphia. The DIA is the one conference where professionals who bring new medicines and vaccines to populations around the world gather to learn about best practices and the latest in regulations governing those practices. I look forward to seeing you there. Daniel Limbach Managing Editor Daniel Limbach Please stop by Booth #1100 at the DIA Annual Meeting to say hello.

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