Saama is pleased to continue our Clinical Trial Excellence for Tomorrow and Beyond blog series, each installment of which will be authored by one of our six new Clinical Board of Advisor members. This week, Scot Harper, Ph.D., President of SLH Group, a life sciences consulting company and previously CEO of Novartis Clinical Operations, address some steps life science industry clinical development executives can take to improve the productivity and performance of their clinical trials in the future.
To get a flavor for how complex clinical trials are to execute and, therefore, why they are so expensive, all one needs to do is review the task list/budget prepared by any CRO for a full-service clinical trial.
To their credit, CROs exhaustively and comprehensively capture what most biopharmaceutical companies historically have not: just how many people/roles/tasks go into the successful execution of a clinical trial. Given this complexity, one of the greatest areas of opportunity in drug development is the streamlining of information flow. This begins with clinical trial planning, protocol development, and country/site selection, all of which can be greatly facilitated by better managing information, in particular separating that which is useful from that which is not.
Throughout the process, there is often great inefficiency in how clinical programs are internally managed. The governance process is greatly hindered by archaic information management that typically goes something like this: trial teams collect and report static information from disparate sources on clinical projects, which they use to populate some sort of standard presentation template, usually several days in advance of some series of project review meetings. By the time the meetings occur, the information is stale and any decisions made are often rendered invalid or incomplete based on what is actually happening.
What would greatly facilitate this process is a single, enterprise-wide clinical project information system, to which all stakeholders have real-time access and from which consistent, real-time reporting is possible. This means much less staff time is spent amassing inaccurate or dated information, and governance meeting time can be spent much more productively, making decisions based upon real-time data.
As a new member of Saama’s Clinical Board of Advisors, I am looking forward to helping Saama refine existing tools which will significantly improve how clinical development programs are managed.
Saama’s Clinical Trial Excellence for Tomorrow and Beyond blog series continues next week with John Fox, Vice President, Global Payroll, Johnson & Johnson and Vice President of Information Technology, Pharmaceuticals Group. Mr. Fox will explore the financial considerations that will drive critical global clinical trial decision-making in the 2020s and beyond.