by Mary Kay Sobcinski, Senior Principal Advisor, Clinical Sciences
No matter how short or long a trip, getting from point A to point B always requires planning. Even a routine trip to the grocery store requires knowing where you’re going, how you’re going to get there, and why you’re going. The more complicated the trip, the more complex and critical the planning process is to ensure you arrive at your destination on time, within budget, and that you have the right list or equipment you need to successfully complete your journey.
Define the Roadmap
You can view your clinical strategy similarly: it’s a roadmap outlining your direction, scope, goals, key stops along the way, and what to do when you arrive to accomplish your objectives. A well-defined, thoughtfully-developed clinical strategy will guide both short- and long-term decisions, prioritize objectives, define and allocate resources, and establish your clinical development program timeline.
Innovative devices require innovative clinical strategies to develop the evidence needed to support your goals. Medical device research, while governed by federal regulations, has an element of flexibility that’s not readily seen in pharmaceutical research. There may be unique clinical trial designs or regulatory pathways to consider; don’t lock yourself into thinking “there’s only one way” to do something, resort to checking off boxes for trial design considerations, or follow a formulaic approach.
Define the Corporate Goals
Before you create your clinical strategy, you need to understand the corporate strategy for the product, including reimbursement, regulatory, and marketing goals. Ask your stakeholders: “What defines success for this project? What are our overall objectives and key milestones?”
Be sure you know what the regulators, payers, and market actually want, not what you think each wants. You need to understand stakeholder expectations and then translate those expectations into results.
Understand the Market
Look at the state of the art alternative and competitive therapies for the disease condition(s) you’re targeting to fully understand your market opportunities and barriers. Many sponsors mistakenly think regulatory approval is the #1 or only goal, but this is rarely the case.
A successful clinical strategy considers all of your product and marketing goals and translates them into a robust clinical program plan, inclusive of individual trial design(s): the right endpoints are crafted, the right investigators are selected, the right patients are enrolled, the right data points are collected, and the appropriate statistical methods are planned to ensure regulatory approval, attainment of maximum reimbursement, successful market launch, and ultimately, market adoption.
It’s All in the Planning
As you design your strategy, define what success looks like – for the trial as well as for your overall product and corporate goals.
- Define success and the accompanying objectives to lay the foundation of your strategy.
- Design the strategy itself: identify the unique project criteria and demands, assess the risks to project success, and develop a risk mitigation plan.
- Identify the tactics (actions) you’ll implement to carry out the plan. Layout and plan your resource needs, ensure your timeline is reasonable and feasible, assess risks that may hinder or even prevent project success and identify mitigations to manage them. Once you’ve formulated your goals into an executable strategy with effective tactics, it’s time:
- Operationalize your plan. Along the way, adapt new tactics to overcome challenges and be open to adjusting goals if warranted. Develop the evidence needed to meet your myriad of goals, and ultimately, communicate your results to the stakeholders and the market.
As a trip plan helps assure a successful journey, mapping out your clinical strategy will steer you to your destination: meeting your regulatory, reimbursement, marketing, and corporate goals efficiently and effectively.
RCRI has expert advisors in clinical strategies and can help at whatever stage you are in your planning. Contact Samantha Thrun at email@example.com or 952-224-2260.