The biggest barrier to shortening clinical trial data cycle times is not recruitment. It is not having a fancy UI for self-service eCRF forms design. It is not software.
It is not, to paraphrase Medidata, having the ability to Run Your Entire Study On A Unified, Intelligent Platform Built On Life Science’s Largest Database.
It is incompetence in managing a construction project.
That construction project is called designing a clinical trial and the information system for collecting and monitoring data.
For a long time, I thought that this was peculiarly an Israeli problem.
However, conversations with colleagues in the US and Europe suggest that late starts, feet-dragging and time-consuming change requests may be the norm. Collecting too many variables in the data model is the norm. Complex, long forms that make life hard for the site coordinators is the norm, Surfeits of edit checks and thousands of queries are the norm.
Most companies spend little money on project management training and even less money on clinical project strategy development. Most training is on process, regulatory compliance and standard operating procedures.
Rarely, do we see medical device companies spend money on competencies that will help employees construct clinical trial projects more effectively.
There are verbal commitments that are rarely action commitments.
Yet there is a direct linkage between clinical operations team knowledge and corporate revenue growth which is dependent upon delivering innovative drugs and devices to market.
One way management teams can maximise their investments in project training and clinical project strategy development (outsourced or in-sourced) is to link clinical operations team training to study management competency models that management can qualify and measure.
But the development of a clinical team competency model has strategic and operational barriers that must be managed to make it successful.
Clinical trial project management competency model example
Clinical team Competency Setup Considerations
1. Clinical people often think that building the ‘database’ is an art, not a science, and don’t like to be measured in what they perceive is a non-core skill.
2. Your project competency model must include both soft and hard skills training to make it effective.
3. Clinical trial management teams must focus on the competency requirements to make it work and it must be a hands-on approach.
4. You must be able to quantitatively measure the competencies (time to design forms, edit check design, monitoring signals, data cycle time, time spent in meetings, change requests).
5. Competency clinical trial management training programs must be continuous training and educational events, not a one-time event or else the program will fail.
6. The steps of your competency program must be very specific and delineated to make sure it can be delivered and measured.
7. Your clinical operations team must agree that the competencies you are measuring truly help them deliver the study faster (They don’t have to like doing it, just agree that there are required action steps to reduce data cycle times)
8. When implementing your project competencies audits, the certification should be both written and experientially measured to get an accurate reading of the clinical operations team member capabilities.
9. All project competency certification candidates should have the ability to retest to confirm skills growth.
10. Project competency assessments should never be used solely as a management scorecard tool to make employment decisions about clinical operations team members.
To increase your company revenues and clinical project training success, build and deliver project competency models.