Implementation Showcase

Cloverleaf Strategies

We helped Cloverleaf Strategies bring a complex curriculum to a powerful conclusion with an immersive and engaging capstone simulation that helped participants to synthesize and apply the concepts they had learned.

The Need 

Cloverleaf’s curriculum teaches compound development teams within pharmaceutical companies how to design clinical trials that will maximize differentiation and value when bringing new oncology treatments to market. The decisions these teams make about the design of a clinical drug trial represent billions of dollars in potential revenue.

Cloverleaf Strategies was looking for an immersive and engaging way for participants enrolled in their 10-module curriculum on clinical trial design to practice applying the concepts they had learned. The learners had completed module-specific activities along the way, but they hadn’t had a chance to combine all of the information they’d learned in one seminal experience. Cloverleaf wanted to conclude the course with a memorable and immersive learning experience that would pull all the content together in a realistic and challenging way. The scenarios needed to have enough data and specialized detail to be accepted by a very knowledgeable audience. And, as a capstone event, it would be the final impression of the entire 10-module program.

The Blueline Solution

Our team started by gaining a clear understanding of the various areas of expertise and identifying the best content to achieve the learning objectives in the allocated 3.5-hour timeframe. We reviewed all the content for the 10 workshops, and then interviewed the Subject Matter Expert (SME) faculty for each module to distill their vast knowledge and expertise down to the core essentials that members of the clinical team would need to incorporate while making strategic decisions for trial design. 

The ultimate challenge for any drug in development is to create a clinical trial that will show that it has sufficient value in the treatment of the target patient to get regulatory approval, to get physicians to prescribe it, patients to use it, and payors to pay for it. There are numerous decisions that need to be made, such as:

  1. What registration path will you take to optimize likelihood of regulatory and commercial success? 
  2. What patient population for the trial optimizes the potential regulatory and commercial success?
  3. What Control Arm gives you the greatest chance of success?
  4. What will be the primary endpoint you will test for in the trial? What will be secondary endpoints and their hierarchy?
  5. How will you allocate Alpha across the interim and final analysis for your primary and co-primary endpoints?
  6. What size will the trial be? (How many patients?)
  7. What real-world evidence will you seek to gather after launch to address any data gaps from trial or to identify additional opportunities?

These critical decisions in trial design and analysis of trial data can have billions of dollars of impact. 

As a platform to design and deliver the content, Blueline’s ExperienceBUILDERTM provided a practical, hands-on experience with the course’s complex concepts from beginning to end in an engaging and fun way. We designed a 3.5-hour simulation focusing on the aforementioned critical decisions that clinical development teams must make when designing a clinical trial that will support regulatory and market success. Each decision was evaluated/scored on five factors: 

  1. Probability of Success (market and regulatory success)
  2. Speed to Market
  3. Differentiation and Value (in the marketplace)
  4. Size of Population
  5. Cost of Development

Prior to experiencing the simulation, learners were notified that there would be a competitive element—knowing that they’d be competing against their peers encouraged them to brush up on key concepts they had covered over the previous months. After every decision, each team of learners received specific feedback on how their choice impacted the five measures via live scoring relative to best practices. The competitive element brought about by the leaderboard and live scoring ensured that every member of every team stayed fully engaged. 

The Result

The ExperienceBUILDER platform provided a cost-effective way to create an immersive simulation that generated the kinds of discussions and decisions that actual clinical trial teams face. Whether learners are collaborating in-person or virtually, the platform provides for all participants to have a consistent experience. 

The Cloverleaf Strategies team appreciated our collaborative approach and flexibility as we went through a number of iterations of the initial design outline and script. This cooperative design and development process helped Cloverleaf Strategies identify the core elements from a long and detailed curriculum and to define the most salient decisions learners would need to make to maximize the simulation’s value and impact. 

To date, post-training participant surveys have revealed that:

  • 90% of participants would definitely recommend the simulation to a colleague

90% of participants believe the concepts covered are directly applicable to their role

  • 90% of participants are now very confident in their ability to shape the clinical development of their asset

A selection of comments from learners:

  • “Fantastic way to end the training and reinforce prior learnings!”
  • “It is absolutely a critical part of the training, and far and away the most powerful component. It exposed areas that were weaker for me and indeed the others on my team.”
  • “It was the perfect way to complete the training.”

“It pulled together all the information we learned over the last seven months. I also learned a lot from the discussion with my colleagues. We have all had different experiences in our careers. The collective knowledge was incredible, and working through our decisions insightful.”

We have since created a demo version of the simulation for Cloverleaf to use with prospects, providing the ultimate flexibility to showcase the aspects that are most relevant to potential prospects.

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