Unlike in the early 1990s, clinical trials are now a well-developed business, with dedicated teams, specialised suppliers and sophisticated technology. Professionalisation has improved participant protection and the reliability of results. Yet, having watched this field develop, I wonder whether we have made trials so difficult to run that some of their benefits are being lost.
Clinical trials are unlikely to die of bureaucracy. But unless we distinguish controls that protect patients and data from processes that merely document compliance, trials risk becoming slower, more expensive and less accessible precisely when technology should be making participation easier.
In Europe, the Clinical Trials Regulation and its Clinical Trials Information System, CTIS, replaced separate national submission routes with a coordinated application and assessment process. This is an important achievement. However, sponsors must still prepare country-specific material, manage document versions, answer questions and meet strict timelines. The next step should be to examine where harmonisation has reduced work and where it has merely reorganised it. Success should be measured in the time needed to open a trial and offer it to patients, alongside the quality of its assessment.
Ethics review illustrates how requirements accumulate. The 1996 Good Clinical Practice guideline already required protocols, consent materials, safety information and evidence of investigator qualifications. Today, reviewers must also understand increasingly complex arrangements involving data, samples, digital tools and external providers. These deserve scrutiny, but its depth should reflect their implications for participants and results. We need proportionate oversight, with attention focused on critical risks rather than the same documentary effort applied to every detail.
Hospitals have also assumed a more explicit institutional role. Trials once closely associated with an individual physician now involve contracts covering staff, facilities, payments, data, insurance and multiple service providers. Each additional party can mean another negotiation before the first patient is enrolled. Responsibilities must remain clear, but routine arrangements should not need to be reinvented for every study. Reusable contractual provisions, parallel preparation and clear decision-making could help research become more integrated into healthcare, while preserving the safeguards specific to experimental treatment.
For patients, the growth in paperwork is most visible at consent. Participation may involve separate choices about optional samples, future research, genetic analyses or digital procedures, followed by further information when the study changes. The aim is to respect autonomy. Yet accumulating pages can obscure the questions patients most need answered: what will happen to me, what are the risks, and can I leave? Future consent should put understandable explanations and meaningful discussion first. Shorter, clearly structured information, with additional detail available, could support informed decisions better than an ever-expanding document. Simplicity must improve understanding without withholding information that matters.
Documentation presents a similar challenge. Trials have always needed reliable records, but today one patient journey may be recorded in hospital notes, electronic case report forms, laboratory systems, electronic diaries and safety databases. Teams must then reconcile information across them. Some duplication serves a specific purpose; some persists because systems cannot exchange data. The goal should be to capture information once and reuse it where appropriate, with traceability, controlled access and checks that it remains fit for purpose. Technology should remove repetitive work and help clinicians see relevant information, rather than give them another system to maintain.
Home visits, remote monitoring and electronic consent could open participation to people who live far away, work, care for others or struggle to travel. Yet a home visit requires trained personnel, agreements, safe handling of samples or medicines, communication with the investigator and reliable records. In my experience, that administrative work can make a clinic visit easier for a site even when travelling brings the patient no clinical benefit. The future should be patient-centred decentralisation: using home visits and remote tools when they reduce burden, while retaining clinic visits when needed or preferred. Practical arrangements must become easier for sites to implement if patients are to benefit.
Cross-border participation exposes another gap. Europe can coordinate the assessment of a multinational trial, yet a patient travelling to another country may still face unresolved questions about language, insurance, payment for ordinary care and follow-up at home. Moving across a border expands potential access without removing the paperwork. The next generation of reform should make participation easier to organise through clear responsibilities, understandable information and workable arrangements between trial sites and the patient’s usual care team. Access should not depend on a patient’s ability to navigate an unfamiliar administrative system alone.
These changes require a different measure of progress. A new platform, procedure or checklist is useful only if it improves protection, reliability or the experience of conducting and participating in research. We should ask investigators and patients where time is lost, test simpler approaches and assess their effects. Removing an unnecessary step deserves as much attention as introducing a new tool. Otherwise, reform risks adding another layer to the processes it was intended to improve.
Every document and approval should earn its place by helping protect a participant, support a clinical decision or make a result trustworthy. When it does none of these, its cost is paid in clinicians’ time and patients’ effort. The future of clinical trials depends on regulation and practice that are proportionate, digitally connected and designed around the people doing the research and receiving the care. Simplicity should become part of how we achieve rigour.