Bill, VP of Clinical Development, entered the room clutching a cup of black coffee. Noticing Charles’s evident distress, he took a deep breath. “Charles,” he began cautiously, “I sense you have concerns with our latest design.”
Charles looked up, meeting Bill’s gaze. “Bill,” he replied, “it’s not the design per se. It’s the lack of consideration for the patient experience. Some of these visits are back-to-back, and the procedures? Far too many in a short timeframe. How do we expect patients to commit to this? It’s our job to ensure patient safety and comfort while also achieving our goals.”
Bill sipped his coffee, pausing for a moment. “Charles, I understand. But we designed this to gather as much data as possible. We’re pushing boundaries here; this drug has the potential to revolutionize treatment in its area. We need comprehensive data to back its efficacy.”
Charles sighed, “I get it, Bill. Data drives decisions. But at what cost? Our recruitment targets are already steep. Add to that a challenging protocol, and we might struggle even more. There’s a middle ground here; we just need to find it.”
Aligning competing interests is essential for ensuring efficient and successful strategic planning, especially in complex environments like clinical development. Here’s a framework that you can use to facilitate conversations and align on competing interests:
Step 1: Define your audience: You will want to ensure the right voices are in the room. Think carefully about who needs to participate in the conversation. Identify key stakeholders from clinical development, clinical operations, and any other departments that might be involved. You want to strike a balance between having enough people to get cross-functional input, but no so many people that you cant align and make decisions.
Step 2: Define the shared objectives: Start by identifying and articulating the shared objectives between clinical development and clinical operations. This usually revolves around things like patient well-being, scientific discovery, and successful product development. Defining shared objectives up front allows you to start from ‘common ground’ before you go straight into the disagreements
Step 3: Lay out the key issues: Then you will want to capture the core concerns of each department. This will drive transparency and keep distractions to a minimum. For clinical development, the key concerns might be:
- Robust Data Collection: Clinical development is laser-focused on designing trials that yield comprehensive, meaningful data. This often involves a complex study design with various endpoints, patient subgroups, and possibly multiple arms. However, the concern is that overly simplistic designs might not capture the depth of data needed for regulatory approvals or to position the drug effectively in the market.
- Scientific Rigor: To ensure the study’s findings are valid and reliable, clinical development wants to maintain a high level of scientific rigor, often leading to intricate protocols. Another concern is that compromising on this could jeopardize the integrity of the trial’s outcomes.\
- Adapting to New Findings: As the trial progresses, new scientific discoveries or interim analyses might drive changes in the study. At iss ue having the flexibility to adapt without causing significant disruptions.
For clinical operations, the key concerns might be:
- Patient Recruitment & Retention: Complex protocols can deter patients, making recruitment challenging. Once enrolled, demanding protocols can lead to higher dropout rates. They concern is that trials that take too long to recruit or have high dropout rates can extend timelines and inflate costs.
- Operational Execution: Smoothly running a trial involves coordination across sites, managing logistics, ensuring compliance, and more. Complex protocols can strain these processes. Another concern is that inefficiencies or mistakes in execution can lead to delays, increased costs, and even jeopardize the trial’s validity.
- Stakeholder Communication: The clinical operations team often serves as the primary communication bridge between the company and trial sites, regulatory bodies, or CROs. A clear, manageable protocol facilitates this communication. Clinops wants to mitigate against ambiguities or overly complex designs can muddy communications, leading to misalignments or errors.
Step 4: Align on what you need to solve for: As the sides lay out their issues and concerns, it becomes easier to create a ‘middle path’ of shared goals:
- Balanced Trial Design: A design that captures necessary data without overcomplicating the process for participants or execution teams.
- Clear Communication Channels: Structures that ensure both departments understand each other’s concerns and constraints, promoting mutual support.
- Flexible Protocols: While maintaining scientific rigor, designing protocols that can adapt to unforeseen challenges without major upheavals.
- Collaborative Problem Solving: Encouraging a culture where both teams work together to address challenges, leveraging the strengths of each department.
This 4-step process can help bridge the gaps that often happen between development and operations, but a focus on framing the key issues, separating the important from the non-important, and creating a path forward can help break the logjam.