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Clinical Trials Summit

    Clinical Trial Business Insights

    OECT Summit: A Report From Germany

    by Imogen Cheese April 4, 2019
    written by Imogen Cheese

    My Imperial colleague Dan McDonald and I had a whirlwind visit across Europe recently. We visited numerous clients in different countries, and our trip culminated with our attendance at the Operational Excellence in Clinical Trials (OECT) Summit in Frankfurt, Germany on March 14 and 15.

    After a hectic start to our week, with several very early flights, lots of turbulence and a string of canceled flights; we were very much looking forward to having our feet on the ground and the chance to network with familiar and new faces.

    The OECT conference brings together clinical operations executives from a number of countries, especially European, to discuss challenges facing the industry in conducting clinical trials efficiently. While a variety of relevant subjects were covered, there was a particularly strong focus on the issue of delayed trial enrollment and the important role that patient recruitment/engagement has in addressing this age-old problem. While we found all presentations to be timely, interesting, and relevant, there were a few that stood out.

    Marta Garcia Manrique, clinical research director for Servier in the U.K., presented Servier’s major initiative to develop a “patient-in” mindset and operating model. She spoke about the significant effort that is going into influencing a cultural change at the company that will permeate into their clinical trial operating environment. Their view of the patient as a critical partner in the clinical research process is both needed and refreshing. Their approach is detailed and multifaceted according to Marta. She highlighted the need for the buy-in and support from senior and influential company executives and the trickle-down effect they can cause. She also mentioned that this movement is not optional and is transversal across study teams. And that active listening is required in order to develop patient-centric trials and/or support systems for study participants.

    I hope to see Marta down the road to learn how the rollout has progressed and I wonder if this is a replicable model that might be shared in the future. It is certainly exciting to hear of an approach that puts patient-centricity at the forefront of its business goals.

    Frank Berger, head of study budget for Boehringer Ingelheim – Germany, gave an interactive and engaging presentation about monitoring and tracking budget planning. This included how to spot where budgets have gone awry and how to predict where issues might arise.

    When a study fails, much of the focus or blame falls to the protocol being poorly designed or the CRO failing to recruit patients. This makes it appear that the concentration of budget misalignment would be at the start or at the end of the process. Frank’s thought process and methods of analysis displayed techniques to monitor and track with far greater accuracy. By following through each activity that takes place during study initiation, you can understand the cost drivers and improve budget accuracy and spend points far more efficiently.

    It’s always refreshing to attend small to medium-size conferences like the OECT where presentations are much more engaging. Discussion gets promoted, and as Frank showed and encouraged with his use of a flipchart placed in front of his slides, if your perspective changes, you can get a greater perception of the issues at hand.

    My colleague Dan McDonald, vice president at Imperial Clinical Research Services, presented findings from a survey undertaken by Imperial that collected feedback from over 400 COMs at sponsor companies. The survey looked at their roles and responsibilities, what barriers they face, and how patient recruitment fits within their roles.

    The resulting data that Dan shared was insightful. So often the people who we and others in the industry see as being the most influential in the area of study recruitment feel the least capable of affecting and influencing recruitment.

    We are all familiar with initiatives in patient engagement, including shiny and exciting innovations, the use of technology, and direct interaction with patients. But all too often these initiatives are rarely introduced in favor of the familiar, commonplace, and not always cost-effective solutions. We stick to what we know and we don’t challenge the status quo.

    That’s why conferences like OECT are so effective. The conversations and dialogue are not just tick boxes or for speakers to obtain kudos at large industry events. We heard about current issues, how other companies are overcoming hurdles, and then we had plenty of opportunities to analyze, question, and challenge.

    We look forward to being involved in many more of these interactive discussions in 2019 and beyond!

    April 4, 2019 0 comments
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  • Clinical Trial Business Insights

    Report from Montreal: Operational Excellence in Clinical Trials Summit

    by Dan McDonald October 4, 2018
    by Dan McDonald October 4, 2018

    At the Operational Excellence in Clinical Trials Summit meeting in Montreal in September, I had the privilege to serve as keynote speaker and a panelist for several discussions. The conference brought together industry thought leaders in the area of patient engagement, study feasibility, and clinical …

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