A broad critique of how trials are designed
A major international study is making a pointed case that too many randomized clinical trials still fail to produce useful answers, even though the fixes are often straightforward. Reported July 1 by Medical Xpress, the research was published in JAMA Network Open as part of the INFORM project, a program focused on improving the informativeness of randomized trials before funding decisions are finalized.
The study draws on interviews with 55 stakeholders from 16 countries across six continents. Participants included trial investigators, funders, ethicists, regulators, sponsors, and industry representatives. According to the report, the central finding was not that the research community lacks ideas for better trials. It was that there is already broad international agreement on practical steps that could make many studies more informative and less wasteful.
That matters because randomized clinical trials remain one of the foundations of evidence-based medicine. They shape treatment decisions, guidelines, regulatory judgments, and health system spending. But if a trial is poorly designed, unrealistic in its recruitment assumptions, disconnected from patient priorities, or unable to deliver a usable answer, the result is wasted time, money, and participant effort.
The INFORM project’s work is framed around exactly that problem. In the source text, University of Aberdeen professor Shaun Treweek argues that a very large proportion of trials are not informative and therefore represent research waste, including a waste of the goodwill of people who agree to take part. His point is not that trial science is broken beyond repair. It is that many improvements are already well understood and could be implemented more consistently.
What the study says should change
The strongest area of agreement identified in the study concerns scrutiny before money is committed. The report says stakeholders supported stronger scientific review before funding decisions are finalized. That recommendation goes to the core of trial quality. If weaknesses in relevance, feasibility, or design are not addressed early, they become harder and more expensive to fix later.
The study also highlights better planning for recruitment and retention. Those two areas are often decisive. A trial that cannot enroll enough suitable participants, or cannot keep them engaged long enough to generate reliable results, may fail regardless of how promising its scientific question looked on paper. By emphasizing recruitment and retention planning, the stakeholders are effectively calling for trials to be designed around real-world execution rather than ideal assumptions.
Improved training for trial teams is another practical step identified in the report. That recommendation suggests that trial quality depends not only on protocols and funding structures but also on the operational capability of the people running the study. Even a sound design can underperform if teams lack the preparation to manage data collection, participant communication, or day-to-day delivery.
The final major theme in the source material is patient involvement. The study says more meaningful patient participation throughout the research process could improve trial informativeness. That goes beyond treating patients as subjects to enroll. It implies involving them in shaping questions, judging whether study procedures are realistic, and identifying outcomes that would actually matter in practice.
Shared concerns across countries and roles
One of the more notable aspects of the study is the degree of consensus it reports. The interview sample spans different geographies, health systems, and institutional roles, yet the source text says participants showed substantial alignment. Lead author Sarah Prowse, a research fellow at the University of Aberdeen, said what stood out was the amount of shared thinking across very different parts of the research system.
That cross-system agreement strengthens the argument that the barriers are less about a lack of knowledge and more about execution and incentives. Participants, according to the report, emphasized the importance of making studies realistic, relevant, and capable of producing evidence that will genuinely be useful in practice. Those are not abstract ideals. They are design requirements for any trial that hopes to influence care.
The study therefore contributes something slightly different from a typical methodological paper. It is not simply offering one new technique or one narrow criticism. It is mapping a broad, international consensus around the idea that trial informativeness should be treated as an upstream priority, especially before funding is awarded and protocols become difficult to reshape.
Why research waste matters
The phrase “research waste” can sound administrative, but its implications are larger than budgeting. A trial that asks the wrong question, cannot recruit successfully, or produces results of limited practical use may delay better evidence from emerging. It may also consume scarce clinician time, institutional resources, and patient trust. In health systems already under pressure, that cost is not trivial.
The source text makes this ethical dimension explicit. When participants volunteer for a trial, they do so with the expectation that the study is capable of answering an important question. If poor planning undermines that goal, the loss is not only scientific. It also affects the credibility of the broader research enterprise.
That is why the study’s focus on pre-funding review is especially important. Funding decisions often determine which ideas move from concept to implementation. If funders apply stronger expectations around relevance, feasibility, team preparedness, and patient involvement, they may be able to improve trial quality before avoidable weaknesses are locked in.
A reform agenda built on familiar tools
What makes the findings notable is their practicality. The recommendations described in the report do not depend on a radical redesign of the clinical trial system. They point instead to tighter scientific review, more credible planning, better training, and stronger patient engagement. Treweek’s comment in the source text captures the frustration behind that conclusion: these are not exotic fixes, and it is hard to understand why they are not already routine.
That may be the study’s most useful contribution. By showing agreement across investigators, funders, regulators, sponsors, and ethicists, it narrows the space for claiming that expectations are unclear. The message is that many parts of the global research system already recognize what informative trials require.
Whether that consensus translates into change will depend on what funders, institutions, and trial leaders do next. But the study offers a relatively concrete reform agenda: test feasibility before making commitments, train teams to deliver, involve patients in meaningful ways, and set a higher bar for whether a proposed trial is likely to produce evidence that clinicians and patients can actually use.
For a field that underpins medical decision-making, that is not a marginal improvement. It is a call to make every trial count more than it often does now.
This article is based on reporting by Medical Xpress. Read the original article.
Originally published on medicalxpress.com
