Question #1: With external forces like an aging workforce, technology, lack of investment in education and the drug development industry notoriously slow to adapt, describe your vision of what the clinical trials industry will look like in 2025.
The clinical research industry has a tendency to be slow to adopt new technology. It doesn’t seem like that long ago that case report form data was entered on paper 3-part NCR forms. Additionally, the FDA Guidance for Risk Based Monitoring was introduced in 2013, and some sponsors are now finally starting to practice risk based monitoring.
While medicine continues to advance and research is conducted, we need to prepare for and embrace technology. When I envision clinical research in 2025, I…show more content… The Clinical Trial Manager (CTM) is responsible for the execution of the clinical trial and management of the study team. The career history of a CTM usually includes roles such as data entry lead, study coordinator or clinical research associate (CRA). This broad background provides the CTM with the knowledge and experience to act as a resource for the study team.
During the next five years, I anticipate the following three industry changes affecting the role of the CTM:
1. Shorter study startup timelines
I believe the length of an overall study will become longer to demonstrate efficacy and safety, therefore the study startup period will need to become shorter. The clinical trial team will need to employ the assistance of the CTM earlier in the study. The CTM is the link between the sites, CRA and program management. This role is integral to the success of the study and must be utilized from the beginning. The CTM should provide recommendations and contribute to the trial design and associated systems. Suggestions include input on data collection and entry, study related documents and
