Why your company should prepare now for digital IEPs

Evidence generation is a complex task. Here’s what it often looks like today: One organization manages about 20 assets across the late product life cycle—phase 2 to phase 4—each with roughly 150 studies and analyses. This creates a constantly changing portfolio book of work that equates to more than 3,000 in-flight activities. Hundreds of personnel across the medical, health economics and outcomes research (HEOR), real-world evidence (RWE), translational, clinical and biostats functions seek to plan, execute and communicate this book of work that sits across multiple IT systems. Worst of all, the primary source of truth for evidence strategy sits on a flat-file PowerPoint deck.

There’s a better way forward. Evidence generation leads are exploring new, digital platforms for working, which we call integrated evidence planning 2.0. We’ve found digital integrated evidence planning can produce six immediate benefits.

Pharma spends extensive resources and time manually unearthing insights from thousands of publications. It takes thorough and tedious research and advanced skills to generate practical insights from market assessments, disease area overviews, stakeholder needs and systematic literature reviews. It’s necessary to review multiple internal and external data to identify true unmet needs and create differentiated evidence to showcase asset value.

In the coming years, companies stand to benefit from an artificial intelligence (AI)-driven evidence reader that can access a wide repository of evidence studies, as well as internal and external publications. This tool can read and analyze scripts to provide intuitive insights, while comparing studies, providing recommendations on study design and inferring evidence gaps to address. It can also assist in faster, efficient and robust decisions without heavy manual effort. Platform collaboration across functional teams will be easier because this evidence reader provides clipboard functionalities for easy note taking and review.

To craft and deliver a differentiated evidence package in large and midsized companies, a team of typically no fewer than 20 cross-functional, cross-market colleagues collaborate on integrated evidence plans (IEPs). This diverse stakeholder base brings unique insights and expertise, but capturing their perspectives can be time consuming and manually intensive, requiring at least 10 weeks of concentrated effort with multiple follow-ups. One example of this is a global integrated evidence lead who sends a survey to affiliate geographies to assess the importance of data gaps, which then must be analyzed and aggregated.

In integrated evidence planning 2.0, global team members will work together simultaneously to edit gaps and open research questions (ORQs), while proposing new activities. The digital platform can be made available for individual pre-work, along with a live discussion format where integrated evidence leads can drive consensus and priority. There will also be company-wide standardization so that all personnel are creating IEPs using identical terminology, structure and detail capture. This will result in faster, easier, more collaborative and higher quality plans.

There exists a many-to-many relationship between evidence generation activities and the evidence strategy. A phase 4 clinical trial will address multiple gaps across efficacy, safety and quality of life, for instance. And almost every gap will have multiple activities—including RWE, investigator-sponsored research, post-hoc and more—to close the ORQs. But the link between activities and strategy is absent today. As a result, gap analysis is nearly impossible and it’s difficult to answer open questions like these:

• When will the gap be addressed?
• How much will it cost?
• Are our current activities sufficient to materially close the gap?

By linking activities with gaps, digital IEPs will enable users to think critically about whether a gap is wholly or partially addressed. And leaders will be able to search across the portfolio universe of gaps to put investment dollars toward the next gap worth addressing.

Once all IEPs across a company have been digitized, there will be an abundant set of valuable use cases for analyzing those plans. Leaders will be able to assess the evidence mix across franchises, assets, indications and activity type. This will lead to them making more informed decisions about the optimal mix of research, such as company-sponsored, collaborative and investigator-initiated research.

Evidence throughput and productivity will be measured to inform resourcing, optimize processes and identify potential valleys in expected scientific share-of-voice, while also helping to ensure efforts aren’t duplicated. Company benchmarks categorized in an evidence plan by therapy area or phase can be derived and shared for guidance purposes. The overall footprint and expertise in specific scientific questions, such as biomarkers, will be quantifiable. The list of decision-making benefits goes on.

Data visualizations and reporting will be at the top of IEPs and provide important information across all levels of the organization. With a simple click, you can see a three-year time horizon of data maturity across all evidence activities and assess the strength of future clinical messages. This data will inform competitiveness and differentiation.

Through system integration, a digital IEP platform can effectively become the evidence generation control tower. All completed, ongoing, planned and newly proposed studies can exist in the asset’s catalog, which represents the cumulative book of work across the life cycle. Users will be able to rapidly query and manipulate the book of work much faster than they can in the static plans of today. In integrated evidence planning 2.0, we will finally have an IEP that can evolve alongside its assets.

Users will be able to see in real time the status of ongoing activities across clinical, translational, HEOR and medical systems that are linked to the asset-indication evidence strategy. These activities will have assigned functional owners and specific leads who are able to create a clear milestone plan so that deliverables are on time and on budget. For enrolling programs, the number of site initiation visits, active sites, screened patients and more will be visible. Expected congresses and publications can be maintained until the final abstracts are expected, preserving a draft publication skyline. Supporting visualizations will give plan executors the information they need to make informed choices, while franchise and department heads will have superior budget control.

A technology- and data-centric approach, with proper roles-based access, data governance, traceability and an audit trail, is needed to realize this vision.

After an activity is completed, the data is usually reviewed, published and communicated through typical channels. But did that study contribute to changing clinical practices? And what was the return on investment?

Organizations need to start proactively capturing the impact of the evidence they generate. A digital platform makes tracking evidence impact simpler, especially as study owners change roles across a company. For example, you can track where a study’s outputs are included across commercial, medical and access resources. Knowing how broadly data is communicated is one measure of success, but we can also see to what degree a study informed a reimbursement decision or a guideline recommendation.

By the end of the decade, pharmaceutical companies will have the technology to support the end-to-end strategy development, planning and execution of integrated evidence. Early adopters of integrated evidence planning 2.0 will have the opportunity to build a wealth of knowledge about the types of evidence that generate the greatest influence and lead to better decision-making. Advanced analytics, data science and automation will create integrated evidence power users who take advantage of human-augmented features and can query scientific knowledge to inform new study design and evidence priorities. It’s exciting to think of a future where every aspect of integrated evidence planning is enabled by technology and not confined to static files.