International Clinical Trials Day: the patient challenges clinical research still needs to solve

International Clinical Trials Day is a good moment to recognise the people who take part in research. It is also a useful moment to look at a familiar delivery problem from the participant side. 

Recruitment, retention and representativeness are still hard to get right. What is worth revisiting is how often those issues are still driven by the same participant-level friction points: lack of clarity early on, too much burden in the protocol or visit model, and practical barriers that narrow who can realistically take part.  

Recent evidence continues to link higher patient burden with worse operational outcomes, including longer start-up, higher screen failure, and more amendments and deviations. 

1. Lack of clarity weakens the funnel early 

A recurring issue in trial delivery is loss of momentum before screening.  

“Patients may be interested in research, but that does not always translate into action. Participation can still feel unclear in practical terms: what is involved, how demanding it will be, whether it is relevant, and whether it will fit around day-to-day life,” commented Romina Goedde, Head of Patient Engagement, FutureMeds Germany 

Wider literature continues to point to awareness, accessibility and restrictive eligibility as ongoing barriers to participation. 

When expectations are unclear, progression tends to slow. In practice, that can mean: 

• slower movement from outreach to screening  

• lower conversion into consent  

• more time spent on poorly qualified leads  

• greater pressure on sites to recover volume later  

  
  

Clearer early conversations and stronger qualification will not solve recruitment on their own. They do improve the quality and predictability of the funnel. 

2. Participant burden shows up later as protocol and delivery risk 

Protocol complexity has increased materially over time. Since 2005, there has been a 139% increase in procedure quantity, a 214% rise in endpoints and a 600% surge in data points collected. As complexity rises, burden typically rises with it, for both patients and sites. 

That burden does not stay contained within the participant experience. It often shows up later in delivery through: 

• lower recruitment efficiency  

• more drop-off around screening or randomisation  

• weaker retention 

• potential loss to follow up 

• higher deviation risk  

• greater need for recovery action later in the study 

“When participation is difficult to fit around someone’s life, the operational impact usually appears elsewhere in the study. The question is less whether it will surface, but more about how early teams identify it and how realistically they plan for it,” added Martin Johnson, Medical Director, FutureMeds UK 

 3. Access constraints affect who gets into trials 

Local availability, restrictive eligibility and uneven awareness still influence who is realistically able to consider participation in the first place.  

FDA guidance on decentralised clinical trial elements notes that remote and home-based approaches may reduce burden on participants and caregivers, while improving engagement, recruitment, enrollment and retention and supporting a more representative trial population. 

“We know that access constraints can limit enrollment options and make timelines harder to protect,” added Gemma Whiteley, Managing Director at FutureMeds @home. 

"We have all seen how the traditional model, over time, narrows the eventual trial population in ways that affect how confidently stakeholders interpret the data. The question we like to explore with our clients is how well operational assumptions match patient reality”. 

What this means in practice 

These familiar but hard-to-solve challenges continue to affect study performance in very practical ways:  

• unclear expectations weaken early engagement 

• burden shows up later in recruitment, retention and deviations 

• access constraints limit the available pool and can affect representativeness 

“Based on our experience, we continue to see these factors contribute to slower recruitment, greater variability, weaker retention and less room for operational error,”

added Arkadiusz Kasperski, Director of Patient Engagement, FutureMeds Poland. 

“Participant experience and study performance intersect in very practical ways. That is one reason our teams across patient engagement, site operations, @home, feasibility are working on increasing patient access, local visibility and reduce avoidable burden.”  

At FutureMeds, this is one reason our teams across patient engagement, site operations, @home and feasibility focus on practical areas such as: 

• clearer early conversations with patients  

• stronger pre-screening support  

• local awareness activity  

• reducing avoidable burden where the study model allows  

• bringing appropriate elements of research closer to patients where it makes operational sense 

International Clinical Trials Day is a good time to recognise participants. It is also a useful reminder that many familiar study risks still begin with familiar participant barriers. 

When those barriers are addressed earlier and more realistically, the benefits usually surface in recruitment, retention and delivery quality.