Evidence-based medicine was introduced in the 1990s as a driver for high-quality patient care. However, this type of intervention is rarely sustained, scaled, or used as intended. In fact, estimates suggest that few evidence-based interventions are adopted into standard practice, and if they are it is often years after initial findings. Moreover, innovative therapies—particularly those that are administered via complex treatment protocols—face barriers to real-world adoption despite proven effectiveness. Implementation science promises to integrate evidence into routine healthcare. In recent years, interest has grown in this nascent field, with many seeing it as a lever for transforming standards of care. It is poorly understood, however.

Overview of Implementation Science

Implementation science aims to promote the integration of evidence-based interventions, including programs, practices, policies, and guidelines, into routine healthcare and public health settings. In contrast to health services or clinical research, implementation science focuses on how interventions are adopted, implemented, and spread. It examines the barriers and facilitators to implementing interventions that have been proven effective and efficacious in clinical settings, accounting for the contextual factors (e.g., intervention characteristics, policy environment, stakeholder perspectives) that may impact successful implementation. Accordingly, the scope of implementation science is broad, targeting patients, providers, health systems, and policymakers, and the approach is multidisciplinary in nature.

The implementation research process follows a standard flow (Figure 1), which begins with identifying a gap between current practice and optimal practice. With input from relevant stakeholders, an intervention is designed to address this gap. At this stage, it is important to include a broad range of perspectives, including providers, patients, researchers, and life sciences companies, to ensure that the l intervention is ultimately accepted and adopted by the intended end users.

Interventions are tested in real-world settings, such as a clinical practice or health system, and evaluated against measure implementation outcomes (e.g., acceptability, adoption, appropriateness, feasibility).

Applications for Life Sciences Across the Product Lifecycle

Though implementation science has been a topic of academic discussion for many years, the application of these methods has been sporadic, as historically no center of ownership for these approaches exist within key stakeholder groups, including life sciences companies. In recent years, life science companies have begun to integrate implementation science procedures across the lifecycle of their products in three primary phases:

• Exploratory: Before launching registrational trials, sponsors have initiated large-scale landscape analyses to examine barriers and facilitators of care within the context of clinical settings. This work has examined both health-system and patient-focused attributes that may limit evidence-based practice. It has generally informed clinical trial programs for therapeutic interventions that have yet to be undertaken.
• Component of Clinical Research: Increasingly, life sciences companies have been experimenting with hybrid implementation designs as part of their clinical development programs. These designs aim to incorporate real-world implementation as a component of more traditional clinical research demonstrating the efficacy of a therapeutic intervention.  These designs extend upon the more traditional work demonstrating the clinical outcomes which can be obtained through a randomized trial by looking additionally at evidence-based interventions, such as clinical decision support tools or shared decision-making aids, that can be used in conjunction with a new therapeutic offering.
• Post-Marketing: Following approval, life sciences companies have often seen stark differences between real-world clinical practice and treatment guidelines that are supported by clinical research.  Manufacturers have partnered with healthcare systems and professional organizations to define these gaps, articulate and develop a solution, and test it in real-world settings for feasibility, usability, and clinical outcomes. A critical success factor in the execution of these studies has been the engagement of multiple stakeholder organizations, including patient advocacy groups, physician stakeholders, and payer organizations.

Avalere’s Approach to Implementation Science

At Avalere, there are four phases through which we go with clients interested in using implementation science approaches to address outcome gaps that align with the approach outlined above.

1. Conduct landscape assessment to identify evidence gaps. We conduct an environmental scan, including a literature review and primary research interviews with patients and providers, to identify how real-world outcomes may differ from those expected under evidence-based care. This can happen before a therapeutic is approved or post-market.
2. Convene experts to address evidence gaps. Using our vast network, we convene national stakeholders to prioritize evidence gaps and define an intervention to address it.
3. Design intervention strategy. Using input from the national stakeholders, we develop an intervention strategy based on the implementation outcomes of interest. These are typically product-agnostic interventions to ensure eventual uptake and acceptability.
4. Implement and evaluate intervention through a partnership with a clinical site. Finally, we partner with a clinical site to implement the intervention and test it with their patient and provider population.

Avalere’s experts help life sciences companies harness implementation science to close the gap between evidence and practice. To learn how Avalere can support you in integrating evidence-based interventions into healthcare and public health settings, connect with us.