Emma Law, Head of Clinical Quality Assurance, makes the case for the moral contract that should sit at the heart of every clinical trial.
As someone interested in both quality and ethics in clinical trials, I have increasingly found myself reflecting on how closely and how imperfectly those two domains align.
For instance, too often in research we treat the experience of trial participation as a secondary concern: something to be managed operationally once the science is settled.
But this mindset misses a deeper point. Reducing unnecessary burden on participants is not simply a design preference. It is a moral obligation that should shape every clinical trial.
Clinical trials have become increasingly complex. Nowhere is this more apparent than in the sheer volume of data collected.
It is reported that phase III protocols now collect an average of nearly 5.9 million data points, representing a 283% increase in data elements over the past decade.
This isn’t merely a statistic. It reflects just how much we demand from people who volunteer their time, effort and trust to take part in research.
Some of this growth reflects genuine scientific progress. For complex conditions, more detailed measurements can improve understanding of safety and efficacy.
But much of the additional data is not essential to the core research question. What’s more, it is often never even analysed.
Participants bear the consequences: more visits, longer appointments, additional tests and increased paperwork. These demands are time-consuming and inconvenient, and they can create financial, logistical and psychological strain.
Historically, pragmatic or participant-centred trial designs have been positioned as a progressive alternative to the status quo. The aim is to reduce burden such as unnecessary visits, integrate research into routine care, and leverage real-world data. All of this should benefit the participant.
The problem is, while these designs have gained prominence, they are often viewed as optional enhancements. They are framed as tactics to improve elements of the trial, like recruitment or efficiency, rather than ethical imperatives grounded in our duty to participants.
However, the consequences of failing to reduce burden are not evenly distributed. This is where the issue intersects powerfully with equity, diversity and inclusion.
Complex, rigid protocols disproportionately exclude people whose lives are less flexible, including those with caregiving responsibilities, hourly wage employment, limited access to transport, disabilities, or conditions that make frequent or long visits difficult.
As a result, trial populations often underrepresent racially and ethnically minoritised communities, women, people from lower socioeconomic backgrounds, and older adults.
In other words, burden is not a neutral inconvenience. It functions as a gatekeeper.
The ethical implications of this reality are deeply anchored in well-established frameworks. For instance, the Belmont Report articulates three core principles: respect for persons, beneficence and justice.
Respect for persons requires meaningful informed consent. Yet consent cannot be fully informed if participants underestimate or misunderstand the practical and psychological demands of participation.
This principle also requires research participants to be recognised as individuals with inherent dignity and moral worth and not regarded simply as a means of advancing scientific objectives.
Imposing unnecessary or excessive burdens, such as additional procedures that do not meaningfully contribute to the study’s aims risks exploiting participants, especially when they are motivated by desperation or goodwill.
Beneficence obliges us to minimise harm and maximise benefit. Procedural burden, including time lost at work, travel costs and fatigue, is a form of harm. If we impose it without clear scientific necessity, we fall short of that obligation.
Similarly, justice demands the fair distribution of the burdens and benefits of research. When burdens systematically exclude certain groups, justice is compromised.
For me, this is why the conversation must shift. Reducing burden should not be confined to “pragmatic” trial labels; it should be embedded across all designs.
The question is not whether we can afford to simplify a protocol, but whether we can ethically justify not doing so.
In practical terms, this means considering every data point and procedure at the design stage and retaining only those that are essential to the study’s endpoints and for ensuring participant safety.
It means engaging patients and communities early to understand what participation genuinely entails for them and mitigating against participation barriers.
It means leveraging and implementing pragmatic trial design elements to minimise unnecessary visits and demands. And it means recognising that equity is not achieved through post-hoc adjustments; it must be built into the architecture of the study from the outset.
Quality in clinical trials is often defined by data integrity, participant safety and methodological rigour. I would argue that ethical integrity, expressed through proportionate, inclusive, participant-centred design and a commitment to reducing undue burden belongs in that definition too.
If we take seriously our commitments to the ethical principles of respect, beneficence and justice, then reducing unnecessary burden is not a methodological choice; it is part of our moral contract with those who make research possible.
This article is based on Emma’s paper, “The undue burdens of clinical trial participation: implications for equity, diversity, and inclusion,” first published in Trials.