The term “strategy” can seem intimidating. But, simply put, a strategy is a choice on how you’re going to tackle a problem or achieve a goal. For example, my family recently sat down to talk about how to get our 12-year-old son to spend less time in front of video games. We decided to have more outdoor family outings and use technology to put a time limit on the computer. This strategy was simple but accomplished our goal.

While an evidence strategy for a product or indication is decidedly more complex than tackling screen time with my pre-teen, the underlying process and goals are quite similar: Identify gaps and determine how to address them. Successful therapies rely on a foundation of evidence to help healthcare providers (HCP), patients, payers, and other stakeholders make informed decisions. An evidence strategy identifies the most important gaps in a therapy’s current evidence — for example, unmet clinical need in a crucial subpopulation — and outlines a plan to close those prioritized gaps. You may hear this referred to as an integrated evidence plan (IEP), integrated evidence strategy (IES), RWE strategy, or similar. The core idea is the same regardless of what you call it.

The rationale for evidence strategies

With finite resources, an effective evidence strategy ensures the right allocation of your time and money to support timely and accurate diagnosis, appropriate use of therapies, and other evidence-informed decisions that lead to improved patient outcomes.

Although good clinical trial planning is a start, it’s not enough. Data analysis conducted by IQVIA has shown that excellent launches are consistently supported by more evidence, and, specifically, more real world evidence (RWE). In three competitive therapeutic areas we researched, IQVIA found that excellent launches had 47% more published RWE than non-excellent launches. And this makes sense. Payers, HCPs, HTA bodies, regulators, and other stakeholders are all looking to evidence beyond clinical trials to:

• Contextualize clinical trial findings
• Understand burden of disease, especially in their populations of interest
• Provide insight on the patient perspective, societal perspective, and other stakeholder needs that are not captured in clinical trial read-outs

Naturally, generating more published RWE alone does not create an excellent launch. It’s not recommended to simply throw money at evidence generation! To ensure your evidence generation is a good use of resources, it is important to plan that evidence out effectively. Going through a cross-functional evidence strategy process aligns your organization around what matters and helps prevent overspending on siloed, duplicative studies.

Best practices for developing evidence strategies

IQVIA has been working with clients for decades to build evidence strategies. At IQVIA Medical Affairs, there are three general phases we go through with clients in developing evidence strategies:

1. We work with a cross-functional team in your organization to identify the evidence needs. It’s important to get input from all key functions and important geographies on those needs.
2. We walk clients through a discussion and prioritization related to those initial needs identified.
3. We assemble a roadmap outlining initial, high-level study concepts. The evidence strategy output and roadmap are then socialized among stakeholders for awareness and next steps.

Note, there are a couple specific methodologies in industry for getting to priority evidence needs, such as challenge and resolution statements, and we customize our support to match client processes. We also recommend externally validating the roadmap and agreed-upon needs. For example, you can validate priority evidence needs or high-level study concepts at an advisory board or by setting up stakeholder interviews for feedback.

Timing is important, and evidence strategy planning that occurs early in clinical development has multiple benefits. Early planning provides the opportunity to think about regulatory pathways, to address key gaps in disease understanding, and to identify issues and implementation barriers that the product may face at launch.

The need to remain flexible

Remaining flexible is crucial in developing an evidence strategy, as even the best-laid plans may need to adapt and evolve. While building the evidence strategy, we encourage people to also discuss potential gaps in patient understandings and potential challenges in the practice of evidence-based medicine for the product or indication. Even though these may not be evidence needs in the strictest definition of the term, they are important to discuss and capture while you have cross-functional input. Following development of the initial evidence strategy, you should maintain a continuous dialogue between teams and external stakeholders to ensure that the evidence strategy remains relevant and effective. We normally recommend updates every 12-18 months, but this depends heavily on the stage of the product and how fast standard of care is changing for the indication. Evidence generation is a long game. While it is important to get to launch with a strong label, a good evidence strategy also contains plans for post-launch studies to support the product’s future.

Conclusions

A strong evidence strategy works alongside a well-crafted clinical development plan. To maximize the impact of an evidence strategy, you should plan early and get cross-functional perspectives to make sure you allocate the right resources to the right areas. In addition, continuously evolving and remaining flexible will ensure you get the evidence you need to support your product at launch and over its entire lifecycle.

A strategy — whether for excessive video gaming or for addressing evidence needs — is simply a choice on how you’re going to tackle a problem or achieve a goal. My colleagues and I work regularly with organizations on evidence strategies and other priorities for Medical Affairs. We’d be happy to answer any questions, learn more about your goals, and support you where helpful in building compelling evidence strategies. Please reach out!