Each year, Clinical Trials Day recognises the scientific advances that improve patient care around the world. It is also a chance to step back and reflect on the people and effort that makes these scientific advances possible. This year's Clinical Trials Day theme is the 'Research Rising' campaign, which aims to 'amplify the voice of the clinical trial workforce and honour patient participation'.
The TRIDENT trial
Results from the TRIDENT trial, recently published in The New England Journal of Medicine highlighted how a low-dose triple combination antihypertensive pill significantly reduced recurrent stroke risk following intracerebral haemorrhage. This was a landmark trial that marks an important advance in secondary stroke prevention.
TRIDENT was a multicentre, randomised global trial involving 1,670 participants across 12 countries at 61 sites, designed to evaluate long-term blood pressure management after intracerebral haemorrhage. From the initial grant application to publication, the trial took more than ten years to complete.
Behind the scenes
While the publication captures the science, it cannot fully reflect the scale of the work behind it. The results were built on years of coordination, practical problem‑solving and sustained commitment from a large and diverse team, many who remained involved with the trial for its entire duration.
Managing a long-term global trial
Managing a global trial of this scale over many years requires continuous coordination across multiple domains and regions: development of the protocol and other documents with translations into multiple languages, countless ethics and regulatory submissions, contracts with collaborators and sites, data management and quality, statistics, management of the steering and data safety committees, manufacture and supply of trial medication and labelling in multiple languages, safety and pharmacovigilance, monitoring, engagement with regional and global collaborators, participant recruitment and retention and the list goes on.
The role of the project team
Over the life of a long-term trial, project teams navigate evolving regulations and clinical trial systems, staffing changes, shifting timelines, and unexpected global disruptions, all while maintaining data quality, overseeing participant safety, and trial continuity. The project team is the backbone of the trial creating stability in an environment that is constantly changing.
Over 10 years, the TRIDENT project team established long term partnerships with sites, investigators and regional coordinators, working through operational challenges, onboarding new team members, and maintaining alignment across countries and time zones.
What the publication doesn't show
Many of the day‑to‑day realities of trial management never appear in a manuscript, such as:
- early morning or late-night calls across multiple time zones
- urgent problem-solving to make sure trial medication with the right language labels are where they need to be
- adapting processes rapidly during periods of uncertainty such as COVID-19, and
- making tough decisions about the trial in the face of an ever-increasing challenging funding environment.
Sustaining commitment over time
The success of trials like TRIDENT reflects not only strong academic leadership and trial design, but also the commitment of the project team that supported the trial year after year. It is quite a feat that the TRIDENT trial maintained its original project manager and several team members from start to finish. Working together for such a prolonged period has developed strong bonds and friendship beyond the professional relationship.
Contribution of participants
Above all, the trial reflects the contribution of its participants. Many remained involved for up to seven years. Their willingness to stay engaged speaks to the trust built between participants, investigators, and the site teams. Without that trust, long‑term trials like TRIDENT simply would not be possible.
Lessons learned
The team has learnt several lessons from TRIDENT about long-terms clinical trial management:
- Flexibility matters - we could never have foreseen COVID-19. Long-term trials demand resilience and adaptability.
- Good communication is essential - adapting communication style to different stakeholders is key.
- Relationships are critical to sustain long term momentum. The importance of personal connection cannot be underestimated. Meeting face to face is essential to build this rapport, particularly across countries and cultures.
- Teamwork underpins success - trust, role clarity and shared ownership create a strong team.
Research rising in action
The publication of the TRIDENT trial in The New England Journal of Medicine represents an important scientific achievement. It also provides a practical example of 'Research Rising' in action that behind every successful clinical trial is a large network of dedicated people working quietly behind the scenes coordinating complexity, solving problems, building relationships, and sustaining momentum over many years.
On Clinical Trials Day, it is worth recognising not only the science that advances healthcare, but the project teams, collaborators and participants whose collective dedication and commitment makes that science possible.
Contributors
Ruth Freed and Natalie Espinosa
