Payers, providers, regulators and other stakeholders are driving demand for comprehensive integrated evidence for new medicines, as they seek additional data outside of what is produced in clinical trials. The future of integrated evidence generation is compelling, with technology making it easier for stakeholders to manage the diverse book of work across all assets in the portfolio. Still, many pharmaceutical companies are in the early stages of determining how they will plan for and generate the required evidence needed to demonstrate a product’s value.
A ZS study conducted in April 2022 confirmed that integrated evidence planning—the process of breaking down functional silos by collectively aligning on critical evidence needs and the best sources of research to address them—is a relatively new focus for many pharma companies. We queried more than 30 leaders at 15 of the world’s top 30 pharma companies and found that 11 of those 15 companies formalized the adoption of integrated evidence within the last three years. After assessing themselves with ZS’s 12-point maturity model (see Figure 1), no company landed in the top third for more than six of the 12 competencies.
This research suggests that integrated evidence capability is relatively nascent, with tremendous opportunities for growth. In the future, and at some pharma companies already, every asset will have an integrated evidence plan (IEP) that details which teams should take what actions to produce this vital evidence. For companies seeking to begin or improve their integrated evidence planning capabilities, the four pillars of ZS’s maturity model—strategy, people, processes and tools—can serve as a useful framework.
Integrated evidence planning offers flexibility. A company can begin an IEP as early as phase 1 or 2 of a clinical trial or wait until recruitment in phase 3. However, our survey found 55% of companies wait until phase 3 to begin IEPs. There are pros and cons associated with waiting to begin an IEP, but we have seen that IEPs are most valuable in the period between when phase 2 top-line results become available and when the product appears in real-world data after its launch. Still, in many cases, key insights gleaned from the IEP process as early as the beginning of phase 2 can significantly shape and improve the development strategy and trial design.
Organizations in the early stages of developing IEPs should ensure integrated evidence is an enterprisewide priority with buy-in from senior leadership. To help build a strong IEP vision for the organization, we recommend conducting pilot studies that can produce small wins and show teams across the company the value of IEPs.
In addition to a strong vision, companies also need a proper governance structure. We found only 47% of companies surveyed have a center of excellence or similar body dedicated to supporting integrated evidence. The first step in taking advantage of the promise of integrated evidence is to ensure you have the right vision and structure in place.
Another challenge in implementing IEPs is the lack of staff dedicated to the process. Most leaders understand integrated evidence is valuable, but it’s often seen as peripheral to the organization’s primary goals. At the leadership level, every company needs accountable integrated evidence owners and a strong project management office to make sure optimal processes are followed across franchises and brands.
Team members involved with IEPs typically support other priorities, such as medical affairs or health economics and outcomes research (HEOR). Our survey found that medical affairs oversees IEPs at 67% of pharma companies (see Figure 2). Medical affairs team members are currently being asked to serve as the bridge between companies’ clinical and commercial teams, but few organizations are offering or encouraging continuing education and professional development around integrated evidence for medical leaders or those leading IEPs.
At the start of an IEP journey, it’s important to have processes in place to guide decision-making, tracking and implementation. Our survey found that about three-fourths of respondents said IEP processes at their respective companies are subjective and qualitative, while 53% said their company manually tracks integrated evidence progress in spreadsheets. Needless to say, there are opportunities for pharma companies to invest in more sophisticated frameworks that formalize the IEP process.
There are two key technology-related factors for companies seeking to advance their IEP capabilities. The first is digitization. Every leader we surveyed cited a lack of robust technology as the main culprit for their IEP operational challenges. About 87% of companies still store IEP-related informational manually, and the platforms and technologies that support integrated evidence fall within individual functions or asset teams. It’s not surprising that almost 80% of respondents said their company lacks a single source of truth that can be accessed by all relevant team members.
While the need for knowledge consolidation and management may seem obvious, only about 27% of the companies surveyed have initiated IEP digitization efforts—and these efforts are often qualitative and lack key performance indicators. Organizations seeking to improve their IEP capabilities should invest in a central evidence catalog supported by dedicated tools so they can collect insights, enhance transparency and promote collaboration.
Tracking the value and impact of IEPs is necessary in the short and long term, but only 47% of companies have a mechanism for valuation measurement. Benchmarking is important for gauging IEP performance and giving leaders the data they need to plan for future IEPs. Mature organizations have piloted a standardized valuation framework and a digitized measurement process for at least some of their assets.
The convergence of an increased need for integrated evidence and the lack of maturity at many organizations creates opportunities for pharma. Even if your company can’t immediately add an IEP for every asset, it’s important to consider actions you can take to increase your company’s maturity.
Some considerations to explore as you advance toward a more-mature integrated evidence practice:
- When in the clinical trial process should we begin IEPs?
- Do we have team members dedicated to IEPs?
- Is there buy-in across the organization?
- Do we have the technology in place to have robust IEPs?
- How should we track our integrated evidence progress and impact?
We believe the answers to these questions can lead you to the right integrated evidence framework for your organization. Now is the time for companies to reexamine their approach and strive to be leaders in this increasingly important field.