Life Science Leader Magazine Supplements

CRO Guide 2016

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LIFESCIENCELEADER.COM THE CRO LEADERSHIP AWARDS 2016 7 ing access to that data would again make her feel very uncomfortable with the decisions she would be forced to make. "We looked at our clinical trials systems and other systems that were available to us," she notes. "I don't think clinical operations had been the focus of high-end technologies in the past, and as a result you find many disparate systems that do not link or overlap in any way. I think this situation is common across the industry, and yet companies still need to collect data from these systems. When the infor- mation you need resides in two different places, it is not straightforward to get that information in a timely manner and know that it is accurate." The Search For An Umbrella Solution To try to simplify the duplicative data that existed, Roche's late-stage clinical opera- tions group, which is headed by Sanders, launched a program titled Trials and Related Information Systems (TARIS) to try to make sense of the linked and relat- ed systems. She acknowledges this effort has taken a lot of resources, and it will take some time to realize the full benefits, but feels that it will all be worthwhile if the end result is a single source of reliable, pertinent data that can be accessed and analyzed at different levels. "One of the goals is to create an infor- mation layer that is an umbrella for all of our clinical trials systems," she says. "If someone wants information, they will not have to go to different systems to get it. In my role, I want to know how we are performing relative to our goals. To do that, I should not have to go to different systems and call on five different CROs. I should be able to see that information on this information layer, because all of the data is being fed directly into it. And we are not set up to capture the basis of that prediction for future reference." Take Individual Experience Out Of The Equation Roche is a huge organization, and Sanders has a staff of over 2,500 individuals work- ing in clinical operations and conducting clinical trials across 60 countries. The size of the organization complicates the importance of the decisions she often has to make with incomplete information. "We are making decisions that have a sig- nificant impact on both clinical operations and the company as a whole," she says. "When a company commits to planning for a certain number of programs, those timelines are based on information from the clinical operations group. But too often those decisions are not based on informa- tion that is easy to analyze or quantify. As someone who is the head of global clinical operations, I can tell you those decisions can make me feel very uncomfortable." Sanders is quick to point out that the source of the information does not make it wrong or mean the decisions based on it are incorrect. She stresses again that often the information is coming from brilliant people with a lot of experience performing trials. But as someone who has come into her position from a technical and scientific perspective, she felt the company — and the industry — could do better. If a method could be devised that would apply scientific, quantitative, and highly tech- nical scientific methodologies to the decision-making process, those decisions would no longer need to be dependent on the experience of select individuals. The first thing she wanted to do was look at what information was available to her. She knew she would need to look at solid data to accurately see what was going on, and she also knew that not hav- hen working in the biomet- rics space, Sanders was used to having clean, manageable, and analyzable data that could be used for modeling and predictions to assess and raise a program's probability of success. She has found that in clinical operations she also has to deal with a lot of data, not just about patients, but about the clinical trials themselves. "The data tells us how many trials are running, where they are, who is running them, how long it takes to run a clinical trial in certain countries, and information on how long it takes to recruit a patient in a specific area. All of this information is extremely quantifiable and valuable to the conduct of a study." But her experience working in clinical operations also has allowed her to look beyond the data. She has found that a lot of the information used in the decision- making process is not data captured in a system or in an evaluable format. It is information and knowledge that exists in the minds of the team members. While there is certainly value in that information, especially when coming from a clinical trials expert with extensive experience, the information is still a snapshot. It is one data point and, as Sanders likes to point out, scientists and statisticians never rely on one data point. "I think this is true throughout the industry," she says. "We have all of this learned information, but it is dispersed throughout the company, and it is not in a format that is analyzable. Additionally, the decisions we make based on this information do not have confidence intervals. One of my most experienced team members might tell me we should be able to recruit a certain study in 24 months. But we have no consistent and quantifiable way of reflecting how sure or confident we are in that prediction, and W

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