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CBI gathered industry professionals in early February for two Philadelphia events: the 5th Annual Patient Awareness, Recruitment and Retention for Clinical Trials Conference and the 3rd Annual Clinical Trial Forecasting and Budgeting Conference. Both meetings, which drew a crowd of about 150, ran the same two days inside the downtown Marriott where all talk centered on how to improve the way things are currently done.
Sights Take Center Stage
For recruitment that means taking a step back and rethinking the process of site selection, a process most attendees easily agreed could use tweaking. "Relooking at things will help you figure things out," advised Atul Mahableshwarkar, MD, Senior Director at Takeda Pharmaceuticals, who added that "this is a team effort, not science and operations being separated."
As such, sponsors must work with their CROs closely and early on to capture the kind of data that can inform selection decisions. "CRO/internal feedback is critical," said Rajesh Menon, MS, MBA, Manager, Research and Development, at Takeda. "They have day to day interaction with centers. They intimately understand the personnel as well."
This type of qualitative feedback paired with quantitative data, such as site resources, failure rates, data query resolution capabilities, accomplishes what Conference Co-chair Christine Pierre, President and Chief Executive Officer of RxTrials, described as the key to the entire process: tying together art and science to predict site enrollment.
And it's in this direction-using qualitative and quantitative data-that industry is moving for a more in-depth evaluation, says Gary Lubin, President and Chief Executive Officer of Centerphase. "Predictability is key," he said, and achieved through thorough protocol review and the right partners. Technology like EHRs can help says Lubin, "but it's only as good as the underlying data. It has to be part of the process and not relied upon."
Other improvement ideas offered:
• Scorecards: These can be developed internally and contain ratings on such soft metrics as whether the site staff were motivated. This knowledge, says Menon, is then later applied to "fit" sites for future studies. Scorecards might also prove useful to sites, suggested one attendee, as they can see where they need to improve.
• Quick kills: Although avoiding sites that won't perform is ultimately the goal, there must be a process in place to cut dead sites and fast. Whether it's 30 days or 60 days, sites should be informed upfront before the study begins of the cut off date and dealt with accordingly. For Lubin, that also means duly compensating the sites that do perform.
• Character checklist: There are certain characteristics you want in an investigator, says Arthur Lazarus, MD, Senior Director of Clinical Development at AstraZeneca. Those include: self-motivated, analytical, team player, and excellent record keeper. Avoid over-promisers and doctors who view research as a side business, warned Lazarus, who advised, "You want a PI who understands the budget and timelines and has a track record of completing on time."
Tighter Purse Strings
In today's economy industry has no choice but to become more efficient, Rama K. Rao stressed during the first presentation of the Forecasting and Budgeting Conference. Rao, Executive Director, U.S. R&D Finance, for Novartis, described the perfect storm battling industry: soaring drug development costs ($1.2 billion +), a decreasing ROI, and higher trial costs. In this context, "we need to go from tactical skills to strategic," said Rao, who listed innovation, process improvement, alliances, and outsourcing as the four key areas that should be part of every strategy.
Conference Co-chair Deirdre BeVard, Vice President, Clinical Operations and Data Management, Endo Pharmaceuticals, backed the idea of alliances, pointing out the value in a match of equals. "If we would see CROs as an equally critical partner, like GM looks at brake manufacturers," she said, "we might be able to make better strides." Because when both sides have skin in the game-a popular phrase used throughout the conference-responsibility is shared, which spreads accountability.
Something else that needs to be shared is information. This requires a sledgehammer and some muscle. "Smash silos to plan study budgets," said Kelly Larrabee, RN, MBA, Director, Clinical Services, ClearTrial. In particular, this means breaking down the walls between the clinical operations side and the financial side. Without input from both, it's harder to plan costs and schedules. By involving all teams, sponsors can tighten budget variation.
"Too often it's a hand off," explained Mike Sherman, Chief Financial Officer, Endocyte, referring to the divide between finance and clinical operations. Sherman, a member of the panel that discussed points of view from the small-to-medium sized pharma or biotech, has seen what happens when both sides share a relationship and accountability. Take, for example, when a problem arises with patient recruitment. "[The] first reaction is not: This is a clinical issue," said Sherman. "They are immediately together to figure out consequences of the situation."
Granted, this type of intimacy is easier to come by in a smaller operation, where teams are 50 people strong. But while it might prove harder and require more effort in a larger company, Sherman believes it is possible. In fact, when it comes to budgeting and forecasting, larger organizations could benefit from applying the same kind of hands-on approach employed by smaller companies, where the numbers and timelines are assessed at least weekly. Again, that might be impossible, the panelists agreed, but in today's challenging times it doesn't hurt to rethink strategy.
Editor’s Note: Applied Clinical Trials and CBI are owned by Advanstar Communications.