Establishing an efficient operational strategy from the start in order to launch a successful trial Dr. Gerald Grossheinrich-Pitschke Head Clinical Trial Delivery 5th Clinical Trials Innovation Program (CTIP) June 27-28, 2016 - Hamburg, Germany
Disclaimer The views and opinions expressed in the following presentation are those of the individual presenter and should not be attributed to any organization with which the presenter is employed or affiliated Seite 2
From an operational perspective what does succesful mean? Recruitment hits the target What could be the reasons that clinical trials miss the target? The protocol is the basis for a successful clinical trial The Set-up is the second important pillar Typical challenges during Set-up can be linked to: The Do-ability has gaps Feasibility is not well-thought through Planning is too optimistic Do you have the right Outsourcing model? Seite 3
Outsourcing models Outsourcing Strategies and Practices to Improve Efficiency and Performance; Aug 11, 2015; By Mary Jo Lamberti, PhD, Frances Grote, Murray A. Abramson, MD, Kenneth A. Getz; Applied Clinical Trials Seite 4
Drivers for Outsourcing? What are the drivers for outsourcing? Nice Insight survey during 2012-2013; http://www.lifescienceleader.com/doc/strategicoutsourcing-often-means-combining-cros-0001 Seite 5
How to shape collaboration? What can be done to optimize the collaboration between Sponsor and Service Provider (SP)? Sponsors and Service Providers sometimes mention the following as areas which need to be considered: Trust Transparency Communication style Adaption of processes Clear responsibilities Seite 6
How to collaborate best? An outsourcing model should enhance the collaboration between Sponsor and Service Provider. This will improve the relationship and increase performance and efficiency. If this works during the Set-up phase then this will work during the conduct of the trial too. Seite 7
Simplification To simplify the collaboration with your SP carefully think about the Standard Operating Procedures (SOPs) to be used during the clinical trial. Further avenues need to be examined as well, including: Documents Systems Contracting Handovers Seite 8
Communication Service Providers and Sponsors need to be partners during the clinical trial in order to: Discuss on an equal level Increase transparency Exchange of expectations don t forget to document those in - contracts - operational manual - decision logs Seite 9
Innovation Less than half of clinical trials conducted today incorporate some type of innovative component. * * Innovations could be: Usage of online pre-screening before site initiation Using data on site-performance from thousands of trials Usage of electronic Informed Consent Form (eicf) *The 2015 Avoca Report - Clinical Development Innovation www.theavocagroup.com/wp-content/uploads/2016/01/the-2015-avoca-report.pdf Seite 10
Specialization & Training Clinical Research in general has become much more complex than in the past. Therefore, it becomes consistently more important to retain trained and qualified individuals for as long as possible and create specialized groups like a Trial Set-Up Team Seite 11
How to optimize the Set-Up? Leading operational Do-ability for each envisaged country collecting information on: standard of care availability of comparator export/import requirements regulatory requirements patient organizations local treatment guidance Preparation of a well-thought operational feasibility Support selection of potential sites Seite 12
How to optimize the Set-Up? Planning and defining the recruitment strategy involvement of professional patient recruitment organization(s) involvement of patient interest/advocacy groups compensatory (back-up) strategies from beginning clarity on wanted and needed countries Raise awareness of all anticipated risks - develop mitigation strategy before things do not go according to plan Creation of project plan with reasonable milestones Plan your budget don t underestimate the costs Seite 13
Performance Most Key Performance Indicators (KPIs) defined in the literature assess the performance after First Subject In (FSI). However, most critical is the Set-up phase of a clinical trial. A correction of an suboptimal Set-Up after FSI costs a lot of time and money. A bad performance during the Set-Up phase is hard to detect. KPIs could be: % of sites actively contributing to online pre-screening before site initiation % of submissions according to planned target Number of major protocol revisions EUCROF WEBINAR - 21Apr2016 Performance metrics in the collaboration between Sponsor and CRO, Philippe Van der Hofstadt, CEO of B&C Group Antoinette van Dijk, Chair Working Group Education & Training EUCROF Seite 14
Summary GRÜNENTHAL Name der Präsentation Datum Seite 15
Summary How to establish an efficient operational strategy from the start in order to launch a successful trial? The following parameters should be considered: Do-ability (protocol) Feasibility (country & sites) Selection of potential sites Define recruitment strategy incl. back-up strategy Creation of project plan Budget plan Seite 16
Thanks for listening Dr. Gerald Grossheinrich email: gerald.grossheinrich-pitschke[at]grunenthal[dot]com GRÜNENTHAL Name der Präsentation Datum Seite 17