To advance science without compromising trial efficiency, we must prioritise simpler user journeys and connected data.
Clinical trials are constantly pushing the boundaries of innovation. Over the past few years, there’s been an explosion of advancements, such as the widespread use of biomarkers in precision medicine, exemplified by initiatives such as Genomics England’s 100,000 Genomes Project, that supports patients with rare diseases and cancer, alongside the increasing integration of real-world and digital device insights.
A large-scale analysis of protocols and other data sources from over 16,000 trials highlighted a trend toward increasing complexity in clinical trials across all the indications evaluated. Complex science often undermines operational efficiency. Over the past seven years, the average number of amendments per protocol increased by 60 per cent. At the same time, the typical time to implement an amendment has almost tripled.
Even making minor changes to a gene therapy trial, such as increasing the number of participants, can significantly impact a study’s success by driving costs up sharply. Overhyped technologies (like decentralised clinical trial solutions) have often fallen short of expectations, leading to lower operational efficiency rather than sought-after improvements.
To avoid a tug-of-war between scientific rigour and operational efficiency, we must focus on the user and data journeys of sites, patients, and sponsors. Simpler everyday experiences with the use of connected data are the foundation to delivering the trials we need rather than what the technology allows.
Helping Sites Remove the Hurdles
Sites have been voicing their concerns for years about the growing technology burden. Common pain points include navigating over 15 portals per study, organising password changes every six to eight weeks, and accommodating each sponsor’s unique definitions, standards, and database setups. Not only do disconnected tools take site staff away from patient care and absorb their time in training, but they also undermine data quality by forcing repeated data entry. Viviënne van de Walle, medical director and founder of PT&R, likens the site experience to being stuck “in a really bad escape room”.
Thankfully, we are turning a corner on delivering better site support. An aspiration of fewer systems will reduce the site admin burden with positive knock-on effects on both patient recruitment and engagement. A better patient experience would then widen access to life-enhancing treatments, particularly in rare diseases. Reflecting on her experiences and needs as a rare disease patient, Helen Shaw, co-founder of the virtual site VCTC, observes: “I see how hard it is to take part in a clinical trial. But patients do want that opportunity to be offered something that they wouldn’t get in their standard care, whether additional MRIs or new medicines.”
Tailoring to Individual Site Needs
Simplifying at a time when science is becoming more complex can feel counterintuitive. But when sites and sponsors shed the legacy systems holding them back, they can finally determine what processes they need to run the trials they want.
Sponsors and CROs (Clinical Research Organisations) are increasingly focused on alleviating a site’s concerns when introducing new systems, even when those systems are ultimately designed to simplify processes. This involves being aligned on shared objectives and working together closely.
All sites are unique, bringing varying levels of technological experience. A ‘one-size-fits-all’ style of interaction is one of the most commonly cited challenges that sites face in their partnerships with sponsors. One clinical trial management software leader notes the impact of this mindset on sites: “Every site can have a different starting point or place of comfort when it comes to implementing technology. The ideal is to remove some of the administrative burden, but sites can have mixed feelings about new technology.”
They add: “Simplifying is a big win. It shows that we’re moving to a mindset of fixing problems instead of just adding more functionality.”
