What the UK’s new clinical trials regime means for pharmacy practice and patient safety

The UK’s new clinical trials regime, which came into force on 28 April 2026, is being positioned as a turning point for how clinical research is run in the UK. Much of the early focus has been on speed and competitiveness, but for pharmacy professionals, the more immediate question is more practical: what does this change mean for pharmacovigilance and patient safety in the day-to-day delivery of clinical trials?

Although the core pharmacovigilance responsibilities of pharmacist professionals remain unchanged, specifically maintaining robust systems to identify, record, report and analyse safety information, the way in which they will monitor and report that information will differ from the previous regime.

One of the most significant structural changes for pharmacy professionals is that they can now formally act as both investigators at site level and as chief investigators across all trial sites. Provided that they are registered with the General Pharmaceutical Council and have the requisite experience and training, pharmacists may now lead clinical trials in their own right. In doing so, their responsibilities extend beyond being a supporting role and will assume direct regulatory responsibility for safety monitoring, adverse event identification and on-site escalation. 

As clinical research continues to extend beyond traditional hospital-based settings, pharmacists will also increasingly encounter trial participants in community and outpatient environments, making the way in which safety information is generated, interpreted and shared directly relevant to clinical decision-making. For example, timely access to reliable safety information can influence a decision to dispense a medicine and related advice to protect their health and wellbeing as well as the integrity of the trial. Such information also supports the identification of emerging safety signals, thereby enabling concerns to be escalated and actioned swiftly.

At the centre of the new regime is a move towards a more interpretive and proactive model of pharmacovigilance^​1​. Sponsors, who take overall responsibility for a trial, are encouraged to embed risk proportionality within their operations, meaning that more professional judgement is expected in how safety data are characterised and reported. This includes assessing emerging safety signals, such as an expected series of adverse events and explaining how risks are being managed as a trial progresses. This marks a clear shift away from standardised reporting towards sponsor-led judgement, with implications for how consistently safety issues are communicated to those supporting care of trial participants.

This is a higher professional standard, which requires that pharmacists’ good clinical practice knowledge is current and properly applied beyond procedural compliance. 

One of the clearest examples of why this is important can be seen in how safety information is reported. The requirement to formally notify investigators — which now includes pharmacists — of all suspected unexpected serious adverse reactions (SUSARs) has been removed. Sponsors retain responsibility for ensuring that relevant safety information is shared, but they now have greater flexibility in how and when that communication takes place. In practice, pharmacists will receive safety information through other means designated by the sponsor, such as ‘Dear Investigator’ letters or ‘Investigator Brochure’ updates — formal sponsor communications used to notify trial sites routinely of important safety developments or updated risk information during a study — rather than a standardised mandatory notification. Pharmacists should proactively engage with their sponsors regarding how and when SUSAR communications will be delivered. 

SUSARs and annual safety reports are also now submitted only to the Medicines and Healthcare products Regulatory Agency (MHRA), regardless of the route through which a trial was approved. Under the previous framework, certain trials required duplicate reporting to both the MHRA and research ethics committees. This is expected to reduce the administrative burden for sponsors as well as creating a more centralised model of oversight.

In practice, this raises an important question: will clinically relevant safety signals always reach frontline teams as quickly and consistently as before? The new regime assumes that sponsor judgement will ensure appropriate escalation, but it reduces the procedural safeguards that previously ensured uniform dissemination.

Another notable operational change is the extension of the written notification period for urgent safety measures from three to seven days, although sponsors must still notify the MHRA within 24 hours of implementing any urgent action to protect participants. This reflects the broader shift towards flexibility and proportionality in reporting requirements as well as alignment with European timelines^​2​.

Importantly, the streamlined elements of the new regime do not extend to safety-related modifications that could significantly affect participant safety or data integrity. These changes continue to require full regulatory review, ensuring that critical safeguards remain in place.

More broadly, the changes are intended to improve the UK’s competitiveness as a location for clinical research. This follows concerns that UK clinical trials had become consistently slow as a result of variable study set-up timelines. In October 2022, an ABPI report revealed that the median time between a clinical trial in the UK applying for regulatory approval and delivering its first dose to a participant rose by 25 days to 247 days between 2018 and 2020, placing the UK seventh among comparator countries^​3​. The report also found that the number of industry clinical trials initiated in the UK per year fell by 41% between 2017 and 2021, with pharmaceutical companies increasingly conducting their trials outside the UK.

The new regime is part of a broader shift towards a more proportionate and flexible approach to regulation. It removes duplication, aligns the UK more closely with international standards, including the EU Clinical Trials Regulation and internationally recognised standards set out by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), and lowers barriers for global sponsors. For example, the ICH E6(R3) guideline states that clinical trial processes and risk mitigation strategies should be proportionate to the risks to participants and the reliability of trial results, and that trial designs should avoid unnecessary complexity.

Faster approval timelines, more predictable processes and closer alignment with international standards reduce friction for sponsors running global trial programmes. This is likely to translate into greater exposure to early-phase and complex trials, including an increase in first-in-human studies. For patients, earlier access to innovative therapies and a greater likelihood that global trials will include UK sites could significantly improve treatment options, particularly in areas of unmet clinical need.

The strengthened requirements around trial registration and the publication of summary results also have practical implications. Greater transparency supports public trust and provides healthcare professionals with improved access to data on the safety and effectiveness of investigational treatments. 

Looking ahead, the full impact of the new regime will become clearer as new studies are initiated under the updated framework. What is already apparent is that safety oversight is becoming more dependent on interpretation and judgment and less on process. As that shift takes hold, pharmacists will play a more active role in bridging the gap between evolving trial data and safe patient care. Their ability to interrogate, contextualise and act on safety information will be critical to ensuring that faster, more flexible clinical research does not come at the expense of patient protection.