You’ve been asked to create an integrated evidence plan—now what?

For many external healthcare decision-makers, it’s no longer acceptable to commercialize new pharmaceutical interventions exclusively with clinical trial data. Stakeholders now expect a complete evidence package that includes real-world outcomes, health economics, practice- and guideline-informing science, as well as patient-centric data, including quality of life and patient-reported outcomes. In response to this new demand, global biopharmaceutical organizations have formalized a new business process called integrated evidence planning, and it’s most often led by the medical affairs team.

Imagine this scenario: You’ve been tasked with creating an integrated evidence plan (IEP) and have received the company’s 100-page playbook. Understandably, you’re immediately overwhelmed. If your organization is typical, you have about eight to 12 weeks to conduct an analysis; prioritize evidence gaps; gain consensus from global, regional and local stakeholders; align on new concepts for investment; and create legally reviewed deliverables for your senior leadership team’s endorsement and budgeting. And while you’ll likely have last year’s IEP, you will need to track down the final PowerPoint deck and make sure it’s up to date. Who wouldn’t feel stressed?

Thankfully, a step-by-step approach (see Figure 1) can help exceed your organization’s expectations for integrated evidence excellence while making the process manageable for you.

When you’re creating an IEP, you’ll want to include clinical development, health economics and outcome research (HEOR) and real-world evidence (RWE) teams, in addition to medical affairs and translational experts, all who deeply understand the organization’s current book of work and can help design and execute new analyses across the full breadth of evidence-generation activities. It’s also helpful to include your commercial team, as they can share long-term product vision, positioning and insights from healthcare providers and payers. Medical—including medical science liaison leadership—maintains a strong pulse on the future treatment algorithm and understands the need for new scientific disclosures to help address clinical research gaps. Geographic market representation is also important to elucidate insights on local reimbursement considerations.

Scientific communications, safety, advocacy, competitive intelligence, customer insights, portfolio, life cycle strategy and other functions may also contribute to IEP development.

IEP development shouldn’t span multiple months, but we often see timelines slip when they’re not managed closely. As a best practice, aligning the process with your organization’s annual strategic brand planning cycle will garner the most attention from the cross-functional, cross-market team. Teams often start their comprehensive gap analysis before kicking off the IEP as an input to the process. Your timeline and communications at the start can focus on three peak periods of activity during the IEP development cycle.

Assessing the current evidence study catalog: All team members who are currently executing evidence activities should provide a complete status update of the current book of work. After all, evidence generation is a formula (see Figure 2).

Determining evidence gaps: You should seek feedback on your proposed evidence objectives, gaps and open research questions. This will require individual pre-work, plus a group discussion to drive consensus and priority.

Choosing new proposals: After reviewing the book of work, it’s important to determine what new analyses your organization should start in the next 12 months to fulfill your product vision in the short, medium and long term. You should encourage creativity and ingenuity while seeking fit-for-purpose proposals to address gaps. In-scope activities will typically include new interventional and observational research, RWE, HEOR, registries, collaboration studies, areas of interest to inform investigator-sponsored research, post-hoc data mining and more.

A data-driven approach to creating an IEP does not involve clinical data. Instead, we’re referring to a thorough gap analysis that will bring objectivity to your final recommendations. Too often, integrated evidence is overly influenced by persuasive or senior voices in the room. You should aim to bring empirical evidence that highlights the most critical gaps to address.

We recommend starting with in-depth stakeholder interviews. The focus of these meetings is to understand the strength of your organization’s current book of evidence and to uncover forward-looking evidentiary priorities. Using the intelligence garnered from the interviews, you can create a framework and perform a document review. It’s important to examine advisory board summaries, field medical insights, post-congress insights, medical information topic volume, commercial assessments, competitive intelligence and other available sources. Beyond document reviews, companies are leveraging intelligent platforms to scan external publications including PubMed, ClinicalTrials.gov, the Pink Sheet as well as resources from the U.S. Food and Drug Administration and the National Institute for Health and Care Excellence. These resources can help companies analyze the current market situation and clinical unmet needs.

A spreadsheet tool like Excel can capture a comprehensive data gaps analysis, as it will be helpful to document the frequency of mentions, the source of the gap, applicable markets, by when the gap needs to be filled, stakeholders of relevance and any other pertinent information.

After identifying potential gaps, you can create a simple internal survey and send it to the full extended team, including all geographic markets, to validate the importance of these gaps and determine a feasible way to address them. For local markets, be sure to use this opportunity to capture local registries and data sources that may have been identified by the country teams.

The synthesis of the interviews, meta-analysis across insights and the survey will provide a solid foundation that the integrated evidence lead can use to substantiate requests for new studies and analyses.

As you work through the integrated evidence planning process, it’s helpful to remember the ultimate goal is to create a differentiating evidence package that will:

• Help to realize the product vision and position
• Address external healthcare decision-maker questions
• Differentiate the asset from other approved and investigational compounds
• Clarify, enhance, validate and reinforce the benefit-risk profile observed in randomized clinical trials, across a broader patient population, under less controlled circumstances, and over the long term
• Shape the treatment of the target disease

We’ve found best-in-class evidence plans usually take a three-to-five-year outlook, but this is sometimes forgotten when a company allocates budget on an annual cycle. Adaptive long-range IEP development is a critical success factor to meet the lofty objectives stated above. Consider this question: What will treatment guidelines look like in five years based on how we introduce our science and product to the marketplace? The answer should be broader than the product simply being the preferred treatment. You should think holistically about diagnosis, ongoing patient assessments, risk stratification, sequencing and more.

As you bring the team together for integrated evidence planning workshops, be sure to capture the big ideas that will span across smaller gaps and help transform the healthcare that surrounds the product.

For better or worse, a comprehensive IEP deliverable is typically a 40-to-80-page PowerPoint deck. This level of detail is needed for a couple reasons. Global, regional and local stakeholders benefit from understanding the future direction of the asset. And the dozens of executing team members will appreciate the level of specificity in the plan to drive the day-to-day workflow. Still, franchise leaders are unlikely to be impressed by this encyclopedia of the current book of work and the line-by-line summary of newly proposed studies.

That’s why we recommend focusing the executive summary on the long-term product vision and how the proposed evidence objectives—if fulfilled—will help the asset reach its full potential. The evidence objectives should summarize the ongoing book of work, along with the most important and highest investment activities that were recently proposed. Additionally, you could plot the key studies across functions on a three-year time horizon, producing a clear story of how your clinical messages and claims will evolve and strengthen. It’s important to be able to clearly explain any expected peaks and valleys in your scientific share of voice, and to note the planned mitigation strategies that will maintain steady evidence dissemination.

A supporting summary should feature a list of prioritized post-hoc data mining that can be produced using existing internal resources. It should also include a one-page summary of on- and off-strategy areas of interest to inform future investigator-sponsored research. In the appendix, you can include the foundational gap analysis, competitive summaries to show how you are filling evidence “white space” and details about how you’re keeping pace with other compounds.

A useful executive summary features contributions from across functions, such as HEOR, RWE, medical and translational; hits on all high-priority gaps; represents a global picture; and showcases innovative tactics, such as imaging studies, digital data collection, artificial intelligence-based work and more.

IEP leads have been given an important responsibility. The future direction of an asset is in your hands to shape and mold with new evidence. Once you’ve created your IEP, it’s vital to regularly update it. Rather than letting it sit on a shelf, it should be considered a mechanism to execute, track and maintain the latest insights.

This checklist should be helpful for any leader developing an IEP.

• Identify the team members who created last year’s plan, as they can provide insight into previous decisions
• Obtain an accurate picture of the current evidence catalogue for all completed, ongoing and planned studies
• Validate evidence objectives and re-prioritize the underlying data gaps that need to be addressed, while considering the latest scientific disclosures and publications
• Identify any new data gaps, considering insights, ad boards, post-congress summaries and local insights across markets
• Brainstorm and drive consensus on any new evidence tactics that should be considered to fulfill data gaps and realize the brand vision and lifecycle management opportunities
• Update areas of interest—on- and off-strategy for a product or disease—to support future investigator-sponsored research