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Clinical trials don’t change fast, but some themes are maturing

Last month I was at the SCOPE EU conference in Barcelona. Here’s what I saw.

Feedback is powerful, and trial participants want to give it. We heard about best practices for collecting patient feedback on protocol design:

  • Ask for feedback early
  • Get a range of input from trial-naïve and experienced patients
  • Consider the caregiver perspective (particularly in rare disease)
  • Collect feedback at a custom point in time for specific protocols
  • Consider asking for ongoing feedback across general therapeutic areas
Data seems more diverse, and easier to access

I hesitated to pull this one out, because ‘data’ is always a focus of content at conferences, but from the sessions I attended it seems data from multiple, diverse sources – real world evidence (RWE), consumer data, electronic health records (EHR) – is increasingly being used to tackle a wider range of challenges, with machine learning techniques helping to wrangle the information towards solutions.

Examples included modelling the root causes of protocol amendments, understanding why sites are not recruiting, and proposing ways to improve diverse and equitable representation in trials. Sponsors can understand how many potential participants they may be excluding due to restrictive inclusion criteria so they can adjust I/E criteria early, and where these potential participants are, so they can consider opening new sites, and sites they may not have used before – which is itself becoming easier, thanks in part to decentralised strategies.

Hybrid strategies are being applied, selectively

A couple of years ago, against the backdrop of COVID, decentralised trials were being touted as a revolution for accessibility and capacity. At the time it was acknowledged that a hybrid approach was more likely to be most appropriate in most cases, and we learned at SCOPE that this is very much today’s reality: practical barriers, including participant concerns around safety and monitoring with DCTs, mean Sponsors are selecting specific remote elements to carry forward into their trials, rather than adopting them wholesale. This provides reassurance to participants that they’re receiving quality of care, without compromising on flexibility with options such as home nursing or self-administration.

Langland has been helping clinical trial sponsors recruit and retain patients for over 20 years. To talk about the power of understanding your patients' trial experience in real-time, please get in touch.

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