I’ve been working with a wonderful company over the past 9 months to pilot a comprehensive approach to RBM in a model that far exceeds the simple adoption of Risk Indicators. It impacts the entire clinical development effort.
The Project lead and I compared notes recently to better understand (and savor every moment) why our effort has been successful. One common thread we identified were jobs we hated, crushed us, etc. that gave us the skills we needed. These jobs, listed below, did not track traditional career paths for us; we each happened into them—luckily (not our original assessments at the time).
The first is sales. UGHHHHH! We both hated many aspects of the entire sales process but it taught us invaluable skills:
- Provide a compelling value proposition for acceptance to each member of each team. Each person may not get direct value from the “product” but each has to see value for the organization. WIFFM (What’s in it for me) has to be provided to each person on the team—not just the decision makers but the influencers too.
- Communication is key. In sales, you must nurture relationships with all team members, not just one. The team dynamic is extremely important. A cohesive team that feels involved and empowered facilitates success in implementing large change initiatives.
- Selling is Forever. Implementing a significant effort such as RBM requires continuous education and reinforcement of all key selling points so the organization continues to understand the metrics and benefits of the initiative.
The second is data management. I have to admit that early in my career, I was one of “those physicians” that said, “I only care about the tables and analysis, not how the data were collected.” Boy was THAT a mistake!
- Understanding data and how you can use data to better perform remote review is critical for successful RBM implementation. This means more than just the clinical data—it includes analysis of operational data and comparing data across databases. MANA RBM’s approach includes remote trial management; the ability to access data and documents remotely is critical to successful implementation.
- Understanding data and technology allows our team members to rapidly assimilate to RBM and remote trial management. Whether you had to do data review from listings as part of your CRA duties or you worked for a company that required you to do both monitoring and DM, understanding data is a paramount skill.
- Using data visualizations can help staff to synthesize data across multiple data sets to provide enhanced quality oversight. My time in graduate school, at the NIH as a PI, and leading DM groups all contributed to developing our proprietary MANA Method for implementing RBM. Stay tuned, we will announce a publication about this exciting area in the coming weeks!
Finally, my academic teaching experience provided an additional, essential skill set in the successful adoption of RBM. The value of effective training/education cannot be overstated. Establishing, an approach to comprehensively train sites and staff members before study start, including new staff hires after study start, is a significant contributor to better quality and study performance.
The bottom line: what appeared to detour your career or wounded it in the past can ultimately help you bring new insight and success in your chosen field and ultimate goals. Stay Gritty!
Let me hear your RBM stories and the detours that helped you succeed.