Patient Technology Implementation Framework

• Outline value proposition, risks, and costs
• Consider current status and future goals
• Identify unknowns and data required to develop a business case
• Define measurable endpoints and KPIs with respect to overall program goals
• Define metrics that teams can use in individual studies to contribute to the overall business case
• Develop plan to track and refine business case over time

• Evaluate potential impacts of the PT program on study design (e.g., costs, sourcing, timing, etc.)
• Identify target segments for use of PT (e.g., therapeutic areas, patient populations, geographic regions). Identify stakeholders and the engagements or inputs required with each
• Identify challenges or risks to adopting PT in the program (e.g., unknowns, risks, costs, timing, patient and other stakeholder burdens, resource gaps, organizational barriers). Engage study teams and other stakeholders as applicable
• Develop a plan to address risks and unknowns through additional research, collaborations, proof of concept development, studies, or through other engagement activities (e.g., regulatory or patient engagement)
• Develop guidelines for study teams to coordinate PT implementation & pilot design across studies

• What do you want to achieve, why do you want to achieve it, and why/how can PT help you achieve it?
• Consider goals and impacts from an organizational perspective, program perspective, patient perspective, etc.

• What has been done in the past, either internally or externally in industry or academia?
• What were the reasons for success and failure?
• What is known about patient needs, priorities, and burdens?
• What does meaningful change look like to these patients?
• Pursue engagements as necessary
• What experiences/capabilities exist within the company?
• Identify learnings from past work and gaps (e.g., processes, resources, expertise) that must still be addressed. Should these gaps be filled internally, or should they be outsourced?

Technical Landscape

• This brainstorming activity should focus primarily on potential use cases, endpoints, and approaches, rather than specific technology options. In general, this stage and its accompanying activities usually precede the selection of a technology, to ensure the technology is fit for purpose

Gather directional feedback from patients, sites, caregivers, or other stakeholders

• Methods: Examples include surveys, interviews, advisory boards, market research techniques, and meta-analyses or reviews of past work
• Goals: Collect guidance or perspectives on direction, privacy, burden, and value; identify factors to consider in future testing; identify health-related factors that may impact PT implementation; etc.

• When testing is not feasible for a specific unknown, identify what will not be tested internally and pursue discussions with the technology’s providers, subject matter experts, or others to assess these features of the PT

• Capture both positive and negative insights and use them to refine, improve, or adapt future technology experimentation. Ensure that learnings are shared and accessible to other teams

• Technology proof of concepts often cannot provide a comprehensive assessment of a technology. Rather, they provide directional insights rapidly to enable better and faster decision- making during technology assessment and design
• Care should be taken to structure proof of concepts in such a way that they answer very specific questions and minimize ‘false failures.’ Since a technology’s full suite of features and support may not be implemented in a given proof of concept, an apparent failure of the technology may in fact be due to overly broad or ambiguous proof of concept design. Clearly define success or failure criteria of these assessments. If a technology does not meet success criteria, first ask ‘Can this issue be addressed?’ before discontinuing the use case or technology

• Outline objectives for the PT use case based on the research question, organizational goals and strategy, and the desired benefits of the PT

• Working with PT may require infrastructure or additional team members compared to traditional clinical trial design. Determine what additional expertise or support you may need (e.g., increased IT support, technology specialists, new data management or analytical capabilities, market research or user experience research capabilities), and engage with appropriate groups early in the development process

• Identify target users of the PT. Identify and characterize target patient demographics, therapeutic areas, geographic regions, trial phases, etc. As needed, pursue patient or caregiver engagements to further develop understanding of needs and priorities
• Identify other stakeholders impacted by the PT use case. This may include internal stakeholders, sites, CROs, caregivers, or others
• Consider regulatory implications of the PT and, if appropriate, engage relevant health authorities for feedback
• Identify the drivers and barriers experienced by critical users and stakeholders, and how they may affect PT implementation. As appropriate, engage with these stakeholders to gather insights

• Identify endpoints, functionality, features, and data streams that will be required or desired to achieve study and program goals
• Identify novel considerations that may impact study design or support. This may include user acceptance, IT infrastructure, data management, validation, translation, or other considerations
• Incorporate perspectives and needs from applicable stakeholders to generate additional requirements. Perspectives can be gathered from engagements, research, past learnings, or published work

• Identify potential technologies, vendors, or technology development options that appear fit-for-purpose and warrant further exploration

• Identify assumptions or unknowns with regard to technical feasibility, value proposition, usability, stakeholder perspectives, regulatory considerations, implementation, and scalability. Identify those that must be addressed to meet study or program requirements
• Identify potential challenges associated with scaling the PT from a pilot to more mainstream use
• Identify challenges or risks to adopting PT in the program (e.g., unknowns, risks, costs, timing, stakeholder burdens) using a risk assessment tool such as FMEA. Engage the technology’s users and stakeholders as applicable

• Develop a plan for addressing unknowns, mitigating risks, and establishing the value proposition for the PT, in preparation for both pilots and scaled solutions
• Identify which critical unknowns can be addressed through additional research, engagement with stakeholders, proof of concept testing (as described in the Technology Proof of Concept Stage), or technology pilots (as described in the Technology Pilot Stage)
• For unknowns that can be addressed through technology proof of concept testing, develop methods and approaches to conduct such testing. Set up a process to capture learnings, and use learnings to improve future testing or piloting activities
• Define success criteria for each phase of testing
• Define backup plans, in case PT does not meet desired success criteria

• Determine the desired scope for the use of PT at scale. Some PT may be appropriate for use with all patients, while others may only be appropriate or effective for certain sub-populations
• Assess the level of difficulty with which the PT can be implemented across different geographies, therapeutic areas, or populations. This could be based on the regulatory environment, language, population acceptance of technology, or other factors
• Prioritize potential use cases, geographies, therapeutic areas, or populations, and develop plan for scaling to them over time

• Identify specific factors or measures that speak to the value of the PT. Provide guidance on how to monitor these factors across studies, and to assess the value of the PT over time
• If necessary or possible, estimate scale required to generate the desired returns outlined in the PT strategy

• Ensure the PT and its use case(s) are feasible for all stakeholders. If the pilot produced findings around patient, site, or other stakeholder burden, take steps to address them
• If additional technical capabilities, infrastructure, data streams or features are required for scaled implementation, create a plan to develop them
• Re-evaluate previously identified risks. Ensure they have been mitigated, or that mitigation plans are in place

• Understand impacts on budget and timeline: Based on previous work and ongoing engagement with providers, model or estimate the impacts of the PT on study start-up costs, lead time, and overall study timeline. Consider potential economies of scale, and identify up-front costs associated with growing the PT and infrastructure
• Understand regional or geographical considerations: Factors associated with scaled implementation may include regional variation in regulations, translation requirements, local characteristics of infrastructure or supply chain, and cultural differences impacting PT use
• Solidify data management, storage, and reporting plans at scale: Ensure vendors and systems have all necessary capabilities to support the particular study, and ensure internal teams and systems have all necessary capabilities to manage this data