Few functions of project management will remain the same over the next decade. The goal of efficiently managing a project from beginning to end will not change. Some day-to-day tasks will remain the same such as training staff, managing study timelines, tracking milestone deliverables, and managing study budgets. Educational requirements will remain the same. On-the-job training will remain the same as companies already require that staff be technologically savvy. The future of project management is exciting because of what will change. In June 2017, Applied Clinical Trials partnered with SCORR Marketing to develop a survey to outline the changes in clinical research over the past decade, as well as possible trends for the next five years.1 …show more content…
One topic not covered by the survey is the increase in the total number and types of studies being conducted. In 2000, 5,627 studies were registered on www.clinicaltrials.gov. At the end of 2017, 263,398 studies were registered.3 This upward trend will only continue, implying that both Sponsors and CROs will require more PM roles. Also, new treatments are emerging for once untreatable or rare indications. As a result, PMs will be clustered more by therapeutic expertise and develop expertise in these new …show more content…
For example, ICH released the E6 Revision 2 Guidelines in 2016.4 In January 2017, ICH issued a “reflection” paper where they stated that the E8 Guidelines will be revised and that they will soon “renovate” E6R2.5 These guidelines affect both study oversight (Sponsor) and execution (CRO). They affect the PM role as traditional management models have migrated to risk-based ones. For example, studies must now have Key Risk Indicators and Quality Tolerance Limits.6 Project managers will lead the industry into this new and exciting future. References: 1). Henderson, L. (2017, June 1). Perspectives of Past, Present, and Future of Clinical Trials. Retrieved from http://www.appliedclinicaltrialsonline.com/perspectives-past-present-and-future-clinical-trials 2). Survey Report – Clinical Trials: Past, Present and Future (2017). Retrieved from https://www.scorrmarketing.com/wp-content/uploads/2017-Clinical-Trials-Past-Present-and-Future-Survey.pdf. 3). Trends, Charts, and Maps (2018). Retrieved from