Developing new treatments and diagnostic tests for infections requires deciding what problems they should solve and how researchers will judge their value. For patients, that value can include getting the correct diagnosis sooner, avoiding unnecessary treatment, and experiencing fewer side effects. Public contributors identified these concerns during the design of PROTECT, a trial evaluating diagnostic technologies to guide antimicrobial treatment.1 The question for developers and funders is how those priorities should influence the research they pursue.
Patient and public involvement (PPI) gives patients, carers, and members of the public a role in shaping research, beyond taking part as study participants. They can help researchers decide which questions to investigate, how to design a study, and which outcomes to measure. In PROTECT, contributors identified outcomes that the researchers subsequently incorporated into the trial’s master protocol.
For developers working on antimicrobial resistance (AMR), meaningful involvement should have a clear connection to development decisions. A team might ask contributors whether its proposed research addresses a treatment problem they consider important, whether its study procedures are acceptable, or whether its planned measurements capture the benefits they want an intervention to deliver. Funders can ask where that input has influenced the proposal and how the team responded.
These questions provide a way to examine patient involvement across research priorities, clinical trials, diagnostics, and treatment development. The relevant tests are whether contributors have an opportunity to influence decisions while those decisions remain open and whether the research team can explain what happened to their advice.
A Historical Gap in the Development Evidence
A systematic review published in Health Expectations in 2017 examined PPI in antimicrobial drug development research. Its searches covered eight databases and English-language publications from 1996–2016.2 Database searching found no studies meeting the search strategy and inclusion criteria; expert recommendation identified one relevant protocol with a brief mention of PPI. The authors concluded that evidence describing its extent, quality, and impact in antimicrobial drug development had not yet appeared in the peer-reviewed literature.
That historical finding establishes the limits of the published evidence available to the review. It does not establish that patients had never contributed to antimicrobial research.
The distinction remains important when interpreting individual projects. Patient involvement in setting priorities, changing a protocol, or improving participant materials provides evidence of influence on research. Establishing effects on clinical outcomes or development timelines requires additional evidence. Developers and funders can assess the research contribution without assuming those further benefits.
Research Priorities as Development Questions
A priority-setting partnership offers a way for patients, carers, and clinicians to identify the unanswered questions they want research to address. The James Lind Alliance’s partnership on chronic and recurrent urinary tract infections (UTIs) used this approach to establish shared priorities for diagnosis, treatment, and care. It covered both children and adults and published its Top 10 research questions in February 2026.3
The highest-ranked question concerned how best to diagnose these infections. The second asked how to treat people who cannot tolerate antibiotics or whose infections have become resistant. Other priorities included pain management, individualized treatment, prevention of recurrence, and whether phage therapy, which uses viruses that destroy bacteria, is effective for chronic and recurrent UTIs. The resulting agenda gives developers and funders specific questions against which to examine a proposed program.
A development proposal can explain which of these priorities an intervention addresses, what the study will measure, and which questions require separate research. For example, a program addressing recurrence should explain how its evaluation will establish whether infections return. Funders can then assess whether the proposed evidence would answer the question that patients, carers, and clinicians identified.
The phage priority makes this relationship particularly clear: the partnership asks whether the treatment is effective, leaving its benefit as a question for research. A development proposal responding to that priority therefore needs to specify the evidence it would generate and how that evidence would address the question.
Diagnostic Trials Can Capture Patient Priorities
The PROTECT study offers a direct example of translating contributors’ concerns into planned measurements. At the protocol-development stage, researchers consulted public contributors about evaluating diagnostic technologies intended to guide antimicrobial treatment and safely reduce unnecessary antibiotic use.1
Contributors identified outcomes that the researchers incorporated into the master protocol, including time to correct diagnosis, admission or readmission to hospital or intensive care, antibiotic use only for the period needed, reduced side effects, and length of hospital stay. Their input connected the proposed evaluation to several aspects of receiving care.
For diagnostic developers, this example prompts a closer examination of the evidence a study is designed to produce. The evaluation plan needs to explain the relationship between the technology’s intended function and the outcomes selected to assess its use. Patient input offers a way to discuss that relationship alongside the scientific and clinical requirements of the protocol.
Contributors also considered deferred consent acceptable when researchers explained its justification and clear patient benefit. They highlighted the need for accessible information, including paper materials and information in minority languages. Their involvement therefore extended to how potential participants would encounter and understand the study.
The publication reports protocol development rather than completed efficacy findings. A funder reviewing comparable work can examine which suggestions entered the protocol and how the team justified its choices.
Consultation and Decision-Making Authority
A German UTI trial comparing an herbal treatment with standard antibiotic treatment established a patient board to discuss research questions, participant materials, recruitment, and dissemination.4 Patients did not participate in final decision-making, and the authors classified the arrangement as consultation.
Patients and researchers nevertheless differed in their assessments of the process. Patients wanted more frequent meetings and more intensive involvement. Researchers considered the patients already intensely involved and viewed the arrangement as beneficial to themselves, the trial, and future research. Patients described personal benefits but also questioned whether their contribution had influenced the trial.
For development teams, the example highlights the importance of explaining who makes decisions, where contributors can influence them, and how researchers will communicate their response. Consultation can serve a clear purpose, but its scope should be understandable to those providing advice.
Funders should assess whether contributors have the influence needed for the role they are asked to perform. A group reviewing participant information has a different task from contributors helping determine research priorities. Describing both simply as “patient involvement” leaves important expectations unresolved.
The German study also shows why a favorable atmosphere or researchers’ satisfaction cannot settle the question of influence. Contributors need an account of what happened to their recommendations, including the reasoning behind choices the team retained.
Involvement Before an Interventional Trial
A sepsis genomics case study published in Research Involvement and Engagement in September 2026 offers an adjacent example from discovery and translational infection research.5 Researchers recruited 14 partners with lived experience of sepsis. The partners helped shape research direction, supported grant applications and plain-language materials, and helped improve the conduct of clinical studies involving long-term collection of patient samples.
The case documents contributions to sepsis research rather than effects on antimicrobial product development or resistant-infection outcomes. Its relevance for developers lies in the opportunity to involve patients before an interventional trial. Early research proposals can identify tasks for which experiential knowledge is useful, including discussion of research direction and how people will encounter sample-collection studies.
Building Involvement into Development Plans
The World Health Organization (WHO) recommends involving patients, survivors, and carers in research prioritization, clinical trial design, and committees evaluating research funding proposals. Its guidance identifies support needs that include financial resources, attention to language and health literacy, mentoring, and accommodation of caring responsibilities.6
Similarly, guidance from Pathways to Antimicrobial Clinical Efficacy (PACE) asks teams to identify where input can influence a project, plan sufficient time and budget, agree on roles and expectations, and understand how feedback informs research priorities and product-development decisions.7 A 2025 commentary published in Nature Communications by Scott-Dearing and colleagues, whose work spans public engagement, patient advocacy, antimicrobial policy, and global health, also emphasizes the time, resources, training, and sustained relationships required to involve the public in developing and testing AMR solutions.8
For developers, these commitments belong alongside the activities contributors will undertake. The plan should identify the decisions they will discuss, assign responsibility for maintaining the relationship, and provide the support needed to engage with the work. Funders can assess why the proposed contributors have appropriate experience, whether their role fits the research task, and how the team will fund their involvement and provide practical support. Recommendations need not produce a change every time, but contributors should receive an explanation of how the team considered their advice.
A funding proposal should identify where patient input can inform development priorities, trial outcomes, or study procedures. The resulting research report should show what contributors recommended, what the team changed, and why it retained other choices.
