CHALLENGES WITH UPTAKE OF YOUR PRODUCT? IMPLEMENTATION SCIENCE COULD BE THE ANSWER
While there are several definitions of implementation science, it is broadly defined as the scientific study of the uptake of research findings and other evidence-based practices put into routine practice. In the last decade, there has been substantial growth of implementation science in healthcare, with manuscript submissions increasing threefold and registered studies with the US Food and Drug Administration and European Medicines Agency seeing a 400 percent increase.
In this blog, Jennifer N. Hill, implementation science research scientist for Evidera, discusses the importance of harnessing the benefits of implementation science and how it can help sponsors to maximize the uptake of their innovations.
WHAT IS THE VALUE PROPOSITION?
Healthcare products are developed in controlled clinical settings, yet they face unexpected obstacles in the real world that can reduce uptake or effectiveness. However, it is not necessary to wait until a product goes to market to understand challenges it might face in real-world settings. By applying rigorous scientific methods to identify barriers and facilitators to the uptake of practices and interventions, implementation science can identify strategies to support accelerated adoption of innovations.
WHAT DOES AN IMPLEMENTATION SCIENCE STUDY LOOK LIKE?
Implementation questions can be considered throughout the development lifecycle, including in the earliest stages during basic research. These questions are ideally answered as part of, or in-tandem, with an ongoing trial but may be collected in a standalone study in-parallel as well. The examples provided below are not intended to be exhaustive, rather illustrative of the type of information that might be gathered at each phase in the development lifecycle to answer implementation-related questions.
During basic research, a study may be undertaken to examine factors impacting practice lab procedures that lead to modifications or deviations and to identify strategies to support best practices in the labs. Findings from this type of study may provide insight into strategic design considerations for Phase I studies.
In Phase I studies, existing information known about barriers to implementation of interventions similar to the one being tested can provide early insights into what the product might expect in subsequent study phases. Phase I studies also provide an opportunity to identify and test strategies to improve engagement and retention in clinical trials, insights which can continued to be tested and refined in later trials.
Phase II study teams may be interested in learning about the barriers to protocol adherence or exploring early questions about feasibility. These studies may also include identification and testing of tailored strategies to support improvements in adherence to protocols based on the barriers identified.
In Phase III a study might focus questions on understanding barriers to implementation of the intervention among clinicians and patients. For example, are there issues with administrative processes or provider awareness or buy-in, and/or are their issues from the patient perspective (e.g., frequency of visits required for treatment)? If barriers exist within the controlled environment of a trial, identifying those barriers, and testing strategies to minimize or mitigate those barriers, provide critical insights to carry into a Phase IV study.
Implementation questions in a Phase IV study may focus on understanding how to replicate the intervention in new implementation settings, barriers to delivery in those settings, and patient-related factors and outcomes in a real-world setting. These studies may also examine cost-effectiveness and sustainability of the intervention in the real-world setting. Insights from these studies can be taken into other settings for scaling the intervention more broadly.
The objectives and design of implementation studies vary depending on the nature of the questions and the phase at which the questions are being asked, and some implementation questions may span phases collecting iterative knowledge along the way that informs and refines an intervention or strategy.
Study designs can be retrospective, prospective or a combination and may involve both primary and secondary data from a variety of stakeholders or other secondary sources (e.g., electronic medical records). Data collected within an implementation study are often complex and may be collected at several different levels (e.g., system, organization, provider, or patient-level). Outcomes may include, but are not limited to, knowledge or attitude change, behavior change, health-related outcomes or changes, process-related changes and policy or system-related changes. Due to the diverse nature of implementation study designs and objectives, a variety of analytic approaches may be used to assess data from various sources.
CASE STUDY: SUCCESSFULLY MOVING FROM AN AT-HOME ORAL TREATMENT TO AN IN-CLINIC INJECTABLE
Two studies, both of patients and providers, one in the United States and one in Europe, were conducted to determine how to most effectively implement a new, long-acting injectable treatment that requires regular visits to the clinic, as opposed to daily oral medication self-administered at home (the current standard of care). Some of this work was conducted prior to product launch!
The sponsor was interested in identifying barriers and facilitators involved in making this treatment shift. Stakeholders offered feedback through surveys, interviews, and facilitation calls. This has allowed the research team and sponsor to better understand who is most suited for the new treatment, what types of clinics and settings may need additional support in implementation, and strategies for patients and clinics to be more successful in the transition to this new treatment. The findings from the studies will be used to help advise and support clinical sites in the effective implementation of this new treatment in a real-world setting (see press release).
Implementation science studies have become increasingly important as healthcare systems look to maximize effectiveness of treatments and care approaches amid resource constraints, increasing costs, and efforts to promote accessibility of treatments to patients (especially in new settings). These studies help to provide insights into what to expect before you reach product launch (early insights collected in earlier stage studies) and what to do when you have those insights entering into the real-world setting (implementation strategies aimed at mitigating or minimizing challenges and barriers).
There is expanding interest in insights gleaned from implementation science studies to support uptake of effective innovations, practices, and products, and that trend is expected to continue. As this interest grows, the need for measures that are developed and tested using established methods to ensure accurate measurement and assessment of processes-related and patient-related outcomes will also continue to grow.