Alicia Staley, chief patient officer at Medidata, explains why the next decade holds the promise of smarter, safer, and more inclusive clinical trials.
Thirty years ago, the clinical trial experience was very different from what it is today. Trials were often siloed from standard healthcare, difficult to find, and even harder to join, particularly for those not treated at academic medical centres. For many, including women and ethnic minorities, access was limited or non-existent. In fact, until 1993, women were largely excluded from participating in clinical research unless the trial related specifically to women’s health – a decision that left significant gaps in understanding how drugs affected half the population.
This lack of inclusion had real-world consequences. Widely prescribed medicines were found to metabolise differently in women than men, raising questions around dosage and safety that should have been addressed in earlier trials. Other overlooked areas included how drugs interact with different ethnic backgrounds, leading to further disparities in patient safety and outcomes. This historical oversight highlighted the importance of building diverse, inclusive trials from the outset, not only to ensure fairness but also to safeguard efficacy and safety across all populations.
Thanks to regulatory changes, there has been a major shift in both access and awareness of clinical trials. More recently, the uptake of digital technologies has accelerated the adoption of decentralised and patient-centric trials, enabled by electronic consent, digital platforms, and wearable devices. Participation no longer demands geographic proximity to a trial site or strict adherence to in-person visits. Empowering patients with access, information, and control has been the key focus of the transformation of clinical trials.
Technology as a bridge, not a barrier
Digital health platforms have made trials more accessible and responsive. Patients can now search for trials to participate in from their phones, monitor their eligibility through integrated health records, and engage with their care teams about participation, all from the comfort of their homes. Electronic health records (EHRs), patient portals, and AI-powered tools work in conjunction to match the right patients to the right studies faster, with improved context and data integration.
The shift toward decentralised clinical trials (DCTs) is particularly significant. Through tools like wearable sensors, patients can now contribute high-quality, real-world data on their activity, sleep, and vitals from home, reducing the need for frequent site visits. Electronic consent (eConsent) and remote monitoring allow participation for those who would otherwise be excluded due to distance, disability, or lack of access to childcare and transportation. These tools don’t just lower logistical barriers, but increase inclusivity and enhance safety by delivering continuous data streams to study teams in near-real time.
For individuals managing complex health conditions, this has been game-changing. Clinical trials are now designed to fit into patients’ lives, not disrupt them. This moves us closer to a true frictionless experience. As a result, trials are becoming more representative and, importantly, more humane. This is empathy in action.
Safety first: Managing risk in the digital era
Patient safety remains paramount. With a growing reliance on digital tools, concerns around data integrity, adverse event reporting, and AI interpretation are front and centre. One obvious learning from the pandemic was that while patients embraced decentralised models, many worried about what would happen if something went wrong while participating from home. Who do they call? Where do they go? These are important, ongoing questions for sponsors and regulators to address as DCTs become the norm.
As digital ecosystems grow, so too must the mechanisms that monitor, regulate and protect patient data. Adherence to global regulations, national guidelines and national standards is non-negotiable. Key frameworks like GDPR in the European Union (EU) and comprehensive FDA Guidance in the U.S. provide vital baselines for data protection and the secure implementation of DHTs and decentralised models, especially with AI integration.
The EU AI Act further safeguards patient well-being and data when advanced AI systems are used in high-risk settings. In the UK, the MHRA’s UK Clinical Trial Regulations ensure robust oversight for patient safety and data integrity in the evolving landscape of decentralised trials.
The future of participation: Where ethics meets AI
AI is expected to deepen personalisation in clinical trials. By analysing layers of structured and unstructured data, AI could vastly improve how we match patients to trials, forecast safety risks, and monitor trial performance in real-time. But with these benefits come ethical considerations.
AI must be trained on clean, unbiased data, otherwise it risks continuing the very disparities the industry is working to eliminate. Ensuring a “human in the loop” approach at every stage of the AI lifecycle is vital. Additionally, by making sure the input into AI is watertight in terms of credibility, AI is much more likely to output reliable, usable data.
Finally, responsible AI use also means being transparent. Explaining what AI models are doing, how they make decisions, and ensuring patients understand their role in shaping the future of medicine is critical to success.
AI can support, but can never replace the trust needed to involve more patients, especially those from historically excluded groups. Trust will always come from us, the people – from local community organisations, clinicians, and researchers working hand in hand with patients to address the barriers they face. This is the human in the loop. These partnerships are crucial in making trials genuinely inclusive and empathetic. There is no other way to achieve a patient-centric clinical trial experience.
Rewriting the rules of participation
The clinical trial landscape has come a long way from paper diaries and burdensome, inefficient processes. Today, we are closer than ever to making trials a natural part of everyday healthcare, where participation is a choice, a true care option, and a contribution to the broader advancement of science.
With technology empowering patients to control their data and participation, and AI set to personalise the experience even more, the next decade holds the promise of smarter, safer, and more inclusive trials. But this is only one part of the puzzle – building trust, listening to patients, and collaboration are the real keys to the future of clinical research.
