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Portfolio‑Level Moves That Make Trials More Representative

Most conversations about clinical trial diversity happen study by study. A protocol struggles to recruit, a post‑hoc review reveals under‑representation in key subgroups, or a particular trial draws public or regulatory criticism. Teams rally, fix what they can, and move on. The next study repeats many of the same mistakes.

Senior clinical development leaders operate at a different altitude. They are responsible not just for individual trials, but for portfolios of programmes that share infrastructure, risk, and reputation. For them, the question is less “How do we save this one protocol?” and more “How do we build an approach to inclusion that works across our pipeline?”

This article outlines a practical inclusion playbook at the portfolio level. It is aimed at leaders who want inclusive clinical trials to be the default, not an exception, and who recognise that the same forces that cause recruitment failure also undermine the external validity and commercial value of their evidence base.

Why inclusion needs a portfolio lens

From a portfolio perspective, health equity is not an isolated ethical issue. It is a set of recurring risks that cut across programmes. Delayed recruitment in one trial may be manageable in isolation. Repeated across multiple assets, it becomes a systemic threat to timelines, budget, and competitiveness. Under‑representation of underserved groups in a single study may be framed as a limitation. Across an entire evidence base, it becomes a challenge to the credibility of your development strategy.

Looking portfolio‑wide also changes how you think about investment. It rarely makes sense to build bespoke inclusion solutions for each trial from scratch. You want reusable components: data, relationships, processes, and tools that can be applied across indications and phases. You want to avoid a situation in which each team negotiates its own approach to patient engagement, community partnerships, and diversity planning, with no shared language or measurement.

From this vantage point, inclusion becomes a matter of infrastructure and governance. It is about setting expectations, providing assets that teams can draw on, and building feedback loops so that lessons from one study inform the next. It is about moving from a world in which each protocol is a one‑off experiment in inclusive design to one in which there is a clear, evolving playbook.

Element 1: A shared definition and standard for inclusive trial design

The first move in any inclusion playbook is to define what inclusive trial design means in your organisation. Without a shared standard, each team will interpret inclusion differently, and it will be difficult to measure or improve performance across a portfolio.

A practical starting point is to adopt a concise internal definition of a health equity‑ready protocol. For example, you might say that a protocol is health equity‑ready if:

• Eligibility criteria have been reviewed for disproportionate impact on underserved groups, and any such impact is justified and documented.

• • Visit schedules and procedure burdens have been assessed against the real‑world lives of target populations, with alternatives considered where necessary.

• Site selection criteria include consideration of access, trust, and cultural competence, not just volume and infrastructure.

• Community engagement and support plans exist for high‑priority underserved groups.

• Regulatory expectations on diversity and patient experience data have been considered at protocol stage, not retrospectively.

This kind of standard can be accompanied by a simple checklist and scorecard, such as the one described in your existing health equity white paper. The details will vary by organisation, but the effect is the same: you create a reference point that teams can design toward and reviewers can assess against.

Once the standard exists, it needs to be embedded in governance. That means making health equity readiness a standing item in protocol review committees, development governance boards, and portfolio reviews. It also means clarifying who is accountable for ensuring that inclusion has been considered and documented. Without this, inclusion will continue to be seen as an aspiration rather than a requirement.

Element 2: A reusable inclusion data layer across programmes

The second element of a portfolio‑level playbook is a reusable inclusion data layer. Rather than commissioning one‑off studies of lived experience for individual trials and leaving the results buried in slide decks, you create a structured, cumulative dataset that can serve multiple programmes over time.

In practice, this often means building cohorts or panels of participants from underserved communities across indications, and gathering both qualitative and quantitative lived‑experience data from them in a way that is linked to social determinants of health. It means standardising the way you code and store insights so that they can be queried by indication, geography, demographic group, barrier type, and design lever.

For example, you might want to be able to answer questions such as:

• What have we learned about transport and scheduling barriers for people with heart failure in the UK and Europe?

• How do people living with NASH in low‑income settings describe the impact of biopsy requirements and fasting visits on their daily lives?

• Which site characteristics have participants from specific communities identified as building or undermining trust?

Over time, this inclusion data layer becomes a strategic asset. It grows with each programme, giving you a richer understanding of how real‑world lives intersect with trial design. It also differentiates you from organisations that approach each trial in isolation, because you can show regulators, partners, and internal stakeholders that your approach to inclusion is cumulative, not episodic.

From a portfolio perspective, this layer can be prioritised. You do not need to build exhaustive lived‑experience datasets for every possible indication at once. You can focus first on areas where underserved burden is high and where your pipeline is most exposed, then extend coverage as capacity and need dictate.

Element 3: Portfolio‑level metrics and dashboards for inclusion

Just as you track timelines, budgets, and key operational indicators across a portfolio, an inclusion playbook requires metrics that allow you to see patterns, progress, and risk.

At minimum, this involves tracking representation by key demographic and socio‑economic categories across trials, compared to the populations affected by the condition in your target markets. It also involves tracking recruitment and retention performance in underserved groups relative to others, so that you can see where particular designs or strategies are associated with better or worse outcomes.

Beyond descriptive statistics, portfolio‑level metrics should include process indicators.

For example:

• What proportion of protocols had a documented health equity review before finalisation?

• How often did lived‑experience data lead to changes in eligibility criteria, visit schedules, or site selection?

• How many trials had formal community engagement plans for high‑priority underserved groups?

These metrics do not exist to name and shame individual teams. They exist to help senior leaders understand where to focus support, where there are pockets of good practice that can be scaled, and where structural changes might be needed in processes or training.

The inclusion playbook can also link these metrics to business outcomes. Over time, it should be possible to see whether trials that meet higher health equity readiness standards are less likely to experience recruitment delays, require certain types of amendments, or face questions from regulators about generalisability and subgroup data. This kind of evidence is powerful in making the case for continued investment and attention.

Element 4: Standard templates for plans that carry across trials

Regulators are increasingly asking for formal plans around diversity and inclusion. These include UK inclusion and diversity plans and US diversity action plans. Rather than drafting these documents afresh for each trial, a portfolio‑level playbook provides standard templates and guidance that teams can adapt.

These templates should do more than capture commitments. They should prompt teams to think through:

• How they have assessed the disease and treatment burden in different populations.

• How they have considered barriers and facilitators for underserved groups in their protocol design.

• Which community partnerships, communication strategies, and support mechanisms they will use.

• How they will monitor enrolment and retention by subgroup and respond if targets are not being met.

By standardising these elements, you reduce duplication of effort and increase the likelihood that plans are grounded in real data and experience, rather than generic aspirations. You also make it easier to compare and learn across trials, since plans share a common structure.

The same applies to internal tools such as health equity risk briefs, site health equity scoring frameworks, and protocol criteria screens. When these are packaged as part of a common toolkit, teams are more likely to use them, and lessons from one project can inform refinements to the tools themselves.

Element 5: Capability building and incentives

No playbook works if people do not have the skills, time, and motivation to use it. Inclusive trial design and the use of lived‑experience data are not niche competencies. They cut across clinical, operational, statistical, and regulatory functions.

At a portfolio level, this suggests three priorities.

First, capability building. This might include training on the principles and practice of working with lived‑experience data, sessions on the regulatory landscape for patient experience and inclusion, and practical workshops on applying health equity criteria screens or interpreting inclusion metrics. It can also involve bringing in lived‑experience experts and community partners to share perspectives directly.

Second, role clarity. Who is responsible for convening or commissioning lived‑experience work? Who is accountable for ensuring health equity readiness is considered at protocol review? How do these responsibilities interact with existing roles in clinical development, operations, and patient engagement? Making this explicit helps prevent inclusion from becoming everybody’s job and nobody’s job.

Third, alignment of incentives. If inclusion is genuinely a strategic priority, it should show up in objectives, performance discussions, and recognition. That does not mean reducing it to a single numeric target. It does mean acknowledging teams that take inclusion seriously, learn from their efforts, and contribute to the evolution of the playbook.

Putting the playbook into practice

A portfolio‑level inclusion playbook is not a static document. It is an evolving set of standards, data assets, tools, and behaviours that should change as you learn what works and as the external landscape shifts.

For senior clinical development leaders, a pragmatic starting point might involve three steps.

First, endorse a clear internal definition of a health equity‑ready protocol and make it part of governance. Second, commit to building a reusable inclusion data layer, starting with one or two high‑priority indications, and ensure that insights from this work are accessible across programmes. Third, introduce a small set of inclusion metrics into portfolio reviews, and use them to identify where support, tools, or process changes are needed.

Over time, this approach can move your organisation from firefighting diversity issues study by study to managing inclusion as a core element of development strategy. It can help you reduce the risk of recruitment failure and unrepresentative evidence and meet evolving expectations on patient experience data not by adding more pressure to individual teams, but by giving them the infrastructure and guidance they need to succeed.

See portfolio‑level health equity risk before it hits your timelines

If you want to turn this inclusion playbook into something concrete for your own pipeline, our white paper “Health equity risk in clinical research: How to see patient recruitment failure before it happens” goes beyond a single‑trial lens. Inside, you will find:

• A structured Health Equity Risk Lens you can apply at protocol and portfolio level

• Examples of how small design changes, informed by lived‑experience data, altered recruitment and retention

• A health equity‑ready protocol checklist and scorecard you can use across programmes

You can download the Health Equity Risk Playbook to pressure‑test your current portfolio and identify where the infrastructure you have is not yet matching the health equity risk you carry.

And if you would like to stay close to the practical side of this, seeing what inclusion infrastructure looks like across a portfolio in heart failure, metabolic disease, oncology, and beyond, you can join Unwritten Dispatches, a weekly newsletter focused on stories from the front line of building Unwritten Health.