Patients as Partners US 2026: Expert Insights

The Progress Era of Patient Engagement: Better Input, Better Experience, Better Outcomes

The 13^th Annual Patients as Partners in Clinical Research Conference, held in Boston, MA March 24 through 26, 2026, reflected clear progress: patient partnership and engagement are moving beyond the “why” and into the “how.” This year, the focus shifted meaningfully toward execution: governance, operating models, measurement strategy, and proof that patient input is changing decisions, not just informing conversations. The practical question underneath many sessions was no longer “Should we engage?” but “How do we build a repeatable, compliant, “decision-grade” system that scales across programs and functions?”

Advocacy and industry leaders are also pushing for more structured approaches and better proof of impact, with growing attention on patient experience data as a regulatory and research imperative.

Unfortunately, this is happening while protocol complexity and clinical trial patient burden are continuing to rise. This strengthens the case for urgency, earlier patient involvement in research design, and more disciplined decision-making around what data and endpoints are truly essential. Patients and advocates are also calling for better feedback loops, information, and data sharing, including returning results to patients and the community in timely and meaningful ways.

The Lumanity view is that the organizations that pull ahead will treat patient engagement like any other enterprise capability: owned, governed, measurable, auditable, and designed to influence specific decisions at defined points in the development life cycle. This includes protocol design, trial experience, endpoint strategy (Clinical Outcomes Assessments (COA)/ Patient Reported Outcomes (PRO)/digital), and Patient Experience Data generation and use. This is the moment to create “decision-grade” patient input: engagement designed to gather perspectives, trigger explicit conclusions and traceable decision impact, and to package cross-functional approaches in a way that can scale to budget constraints. Alongside this must be a commitment to do this in lockstep with patient communities and to publish, share, and iterate best practice to push the industry even further forward.

Core insights and takeaways

1) Patient partnership is entering the operating model era

• • Visibility of structures: the conference agenda moved from a broad call to action to share best practice and tangible proof that action is being taken

• • “Frameworks and guardrails” were a recurring theme, including how to operationalize patient voice responsibly

• • Senior roles and formal ownership structures (including C-Suite and Chief Patient Officer positions) are becoming more visible, suggesting the capability is being institutionalized rather than treated as a side initiative

• • Multiple pharma examples acknowledged discomfort and learning curves, with a consistent message: start small, learn fast, find internal advocates, and persist

Lumanity perspective:Patient engagement should be designed like any other business-critical process: owned, governed, measurable, and auditable. Build the “engagement-to-impact trail” that leaders increasingly ask for: what patients said, what changed, and what decision it influenced. Share both successes and lessons learned internally and externally.

2) “Treat patients like colleagues” is a practical reframing

• • The framing of patients as true collaborators landed because it is simple and operational

• • If patients are colleagues, teams must define roles, influence, timing, and feedback loops, and they must manage burden and compensation fairly within compliance constraints

• • It implies shared purpose, mutual respect, and 2-way accountability, not a 1-directional “input request”

Lumanity perspective:

Many organizations can “run engagement.” Fewer can run it consistently across assets/regions with the same quality bar. A colleague-model encourages templates, standards, and defined decision rights.

3) Protocol complexity and data collection are now quantifiably colliding with burden, and early patient input is positioned as a lever

• • Ken Getz shared updated Tufts Center for the Study of Drug Development (CSDD) data illustrating that protocol complexity in Phase 3 pivotal trials has increased meaningfully over the last decade, with a plausible link to retention challenges and other operational issues.

    • • Initiation duration (+27.2%)
    • • Enrollment duration (+36.9%)
    • • Total protocol deviations (+184.6%)
    • • Substantial amendments (+52.2%)
    • • Dropout rates (+105.1%)

• • A key nuance in Getz’s update was moving beyond “complexity” as a vague complaint and quantifying non-core and non-essential data collection:

    • • More than one-third of all data collected comes from non-core and non-essential procedures, contributing ~25% to 30% of total participant and site burden
    • • Participant questionnaires and diaries are disproportionately high sources of non-core and non-essential data
    • • Safety and exploratory/future use were cited as leading reasons why non-core data are collected

Lumanity perspective:

Reducing burden is not only an ethical imperative; it is a performance lever tied to feasibility, retention, and execution risk. Bring patients in at protocol development, not after the design is largely set. Define a burden baseline, set simplification targets, and track whether changes reduce amendments, deviations, and dropout risk.

4) Decision-grade patient experience and input include “no-go” conclusions, especially in PRO and COA work

The conference messaging was explicit that “decision-grade” engagement is not just richer qualitative insight; it is patient input designed to resolve a defined decision. That includes stopping work when the patient community signals a measure is not feasible, not meaningful, or not worth the burden. This challenges a persistent bias in measurement strategy: that progress equals producing a new instrument or “making something work” rather than deciding it should not be pursued.

• • Hearing that an instrument is not a good fit can be more valuable than forcing it or investing in new development

• • This challenges the common belief that “progress” always equals producing a new measure

The conference connected this to the broader burden/complexity reality: trials and data collection continue to grow, so adding measurement “just in case” is no longer benign. Earlier patient engagement is being positioned as a lever to simplify protocols and reduce execution risk, with a stronger call for measurement of impact (not just anecdotes).

• • A disciplined “no go” is an efficiency and quality win. It protects timelines and avoids building endpoints that fail feasibility or relevance tests later

Lumanity perspective:

A disciplined “no go” can be a value driver, not a failure:

• • Prevents downstream feasibility failures (eg, low completion, non-adherence, high site burden)

• • Avoids investing in endpoints that are not meaningful to patients (risking weak interpretability and credibility later)

• • Reduces amendment risk and operational drag by removing low-value measurement before a protocol hardens

• • Make “no go” safe internally: many teams avoid “no go” because it creates friction (eg, with scientific curiosity, legacy endpoints, or cross-functional stakeholders). A practical step is to pre-align that “no go” is a legitimate outcome and define what happens next (alternative endpoint, alternative timing, alternative mode), so teams are not left with a void

5) Digital endpoints should meet the same patient engagement standard as COAs and PROs

• • Digital health technology–supported endpoints are here to stay

• • Patients add value by shaping fit for purpose, feasibility, and meaningfulness, similar to COA development

• • The practical warning was clear: do not treat digital endpoints as tech led and COAs as patient led. Both require patient shaping to be credible and usable

• • The digital sessions reinforced that many sponsors are evaluating if digital technology can create patient engagement and insight that are:

    • • broader and more representative (“more countries, populations, and studies”),
    • • available faster (“on demand”), and
    • • formally connected to decisions from design to delivery (rather than sitting in disconnected reports)

• • Digital endpoints and data capture are especially vulnerable to “quiet failure” modes:

    • • Patients technically enroll but do not adhere to passive/active data capture over time
    • • Devices are accurate, but workflows are annoying; friction drives non-adherence
    • • Measures generate data, but patients don’t experience the endpoint as relevant, so engagement drops
    • • Sites and vendors struggle to support the digital workflow, creating avoidable operational burden

Lumanity perspective:

Don’t let engagement become “tech led” by default. The conference made it clear that digital health technology–supported endpoints are now durable, but they will underperform if patient shaping is treated as optional. Digital endpoints require the same level of patient partnership rigor as PRO/COA development: fit for purpose, feasible, meaningful, and usable in the lived reality of participants.

If you want digital endpoints and engagement at scale, you need patient voice at scale, ideally embedded into core study design tools and governance, not handled as bespoke engagement each time.

6) The generation and value of patient experience data are broadening; patient experience mapping is timely, but scaling depends on commercialization reality

• • There was notable interest in a broader range of patient experience data beyond patient preference data

• • Patient experience mapping is a structured qualitative data collection and visualization method that organizes information about a patient’s healthcare journey (ie, symptom onset, diagnostic processes, treatment pathways) and lived experience factors (ie, emotional health, social support, economic impact, etc). It was positioned as a cross-functional, “living process” spanning R&D, clinical operations, medical affairs, and commercialization, with potential ownership by patient engagement leaders

• • The constraint is practical: budgets often sit elsewhere. Adoption may require modular packaging and a clear buyer

Lumanity perspective:

The science and methodology may be sound, but enterprise adoption hinges on how the work is packaged, funded, and reused across functions. Start with a modular entry point that one function can sponsor. Produce outputs that clearly serve multiple audiences. Make the value story explicit: time efficiency, cost efficiency, fewer internal resources, and reusable assets.

7) The pediatric voice is critical to capture in clinical trials

• • The pediatric voice is critical to capture in clinical trials; pediatric engagement is not “token engagement plus caregivers”

• • The pediatric sessions underscored a key point sponsors sometimes underestimate: the pediatric trial experience is not only a patient experience but often a whole–family system experience, and youth have distinct preferences, constraints, and trust thresholds

• • Children can provide concrete, implementable design input when the engagement format is built for them and when ethics/compliance are treated as trust enabling, not as a barrier

Lumanity perspective:

Burden drives feasibility (especially with school, family schedules, and visit load). Youth willingness depends heavily on study intensity and fit with busy schedules, meaning that “feasible on paper” can be infeasible in real life unless you test it with youth early. Digital strategies can increase acceptability if they match how youth prefer to engage. Youth often prefer app check-ins and app notifications (vs phone calls), suggesting that the “channel strategy” is itself a feasibility lever in pediatric trials.

Privacy controls need to be designed, not assumed. Older youth want privacy/consent options around parent visibility; this becomes critical for sensitive concepts captured via e, diaries, or digital endpoints (symptoms, mental health, social functioning).

To credibly claim pediatric patient centricity, especially with digital endpoints, sponsors should treat pediatric voice as an essential design input.

8) The FDA update reinforced continuity and increasing practical structure around Patient-Focused Drug Development (PFDD)

• • There are clear signals that Patient Experience Data are expected to be more systematic, more submission ready, and more consistently integrated across drugs, biologics, and devices

• • PFDD remains a core FDA priority and is explicitly framed as a systematic approach to capturing and incorporating patient experience in development and evaluation

• • The FDA reiterated its role boundaries: it doesn’t develop drugs or run trials, but it does guide, advise, and evaluate, reinforcing that sponsors must own fit-for-purpose patient evidence strategies (with the FDA as an engagement partner)

• • A key execution signal: the FDA highlighted efforts to standardize how Patient Experience Data are packaged and submitted (eg, COA dossier; electronic common technical document (eCTD) technical conformance) alongside PFDD methodological guidance and training, raising expectations for “submission-grade” PED

• • The FDA indicated continuity of PFDD listening mechanisms (including upcoming externally led PFDD meetings) and ongoing work on patient preference study guidance—helpful reassurance amid broader ecosystem uncertainty

• • Rare disease and devices received dedicated attention: the Rare Disease Innovation Hub is positioned as a focal point to accelerate rare disease therapy development and provide a centralized point of contact, while the Center for Devices and Radiological Health (CDRH) reinforced the value of patient voice in benefit–risk, design, and regulatory decision support

• • There was no formal update on DEI guidance or approaches, and sponsors were encouraged to “continue with business as usual and implementation of their own organizational standards”

Additional signals

Feedback loops are becoming table stakes

• • There is growing expectation to return study results to participants in meaningful ways

Representation is being reframed as “good science”

• • Shifts in corporate DEI posture are pushing teams to ground representativeness in scientific validity and evidence quality

Patient burden is also structural and financial

• • Trials are more complex, and data collection demands on patients continue to rise

• • Practical frictions remain, including reimbursement issues

AI is being discussed as a patient centricity enabler

• • AI is being framed as a tool to reduce manual clinical development work, translate scientific evidence into lay summaries, preserve historical memory, and enable more continuous interrogation of data

What leaders should do now

1. Define the operating model: ownership, governance, and practical guardrails, so engagement is repeatable and compliant. Describe a clear upward communication plan for leadership and externally to advocacy partners

2. Build an engagement-to-impact trail: what patients said, what changed, and what decision it influenced, and critically, including a strategy for information and data dissemination to patients and the community

3. Target burden early: pick 1 to 2 protocol design choices and/or potential “non-essential data capture” activities and involve patients at the development stage, evaluate barriers, and then track what changed and what it improved

4. Make patient input decision grade in measurement strategy: add explicit “go” and “no-go” gates in PRO and COA plans, and include the pediatric voice early where relevant

5. Apply the same standard to digital endpoints: validate feasibility and meaningfulness with patients, not just technical performance, and package cross-functional PED work in modular ways that match real budget ownership

Walking out of Patients as Partners this year, what stayed with us most wasn’t a new idea or approach; it was the shift in what people seem willing to hold themselves accountable for. The tone has moved past “We value the patient voice” and toward a harder question: “Can we point to specific choices that changed because patients were involved, and can we do that reliably across programs without it collapsing under real-world constraints?”

At the same time, there was an undercurrent of urgency that felt different than in prior years, more grounded, and frankly more emotional. The broader environment is uncertain, and many teams are operating in “lower-risk” mode; patients and advocates can feel that, and there was a clear message that progress won’t sustain itself on good intentions alone. If we don’t build belief through follow-through (and show, quickly, what changed), we risk stalling right at the moment when we finally have momentum.

What we have learned, again, but with greater clarity, is that the biggest takeaway is still practical: reduce burden earlier, and be disciplined about what’s truly essential; close the loop with participants so engagement doesn’t feel extractive, and design patient input to answer real decision questions (including being willing to call “no go” before we bake in endpoints or approaches that will quietly fail). That thread ran through protocol design, endpoint strategy, digital strategies, engagement partnerships and approaches, and how we are thinking about lived experience and patient evidence more broadly.