Everything you need to know about clinical trial legislation changes

On 28 April 2026, the Medicines and Healthcare products Regulatory Agency (MHRA) and Health Research Authority introduced what they described as “the largest package of reforms in over 20 years” for clinical trials that will mean “patients benefit from earlier access to the latest innovative medicines”.

The reforms allow for faster set-up of low-risk trials and modification to pre-existing trials to be approved quicker, as well as the use of early data from overseas studies and computer model simulations to predict how new medicines may behave before they are tested in patients. Researchers could simultaneously apply for ethics and regulatory approval for new clinical trials of investigational medicinal products, speeding up the time it takes to set up a trial.

In addition, pharmacists could act as investigators and chief investigators for trials. Under supervision legislation due to come into effect in December 2026, pharmacists will be able to authorise pharmacy technicians to supervise the assembly of investigational medicinal products^​1​.

In its announcement of the reforms, the MHRA said it had already made headway by cutting the time it takes to set up clinical trials from 169 days to 122 days, beating the government’s target of 150 days in its NHS ten-year plan^​2,3​.

At the time the legislation was introduced, then health minister Zubir Ahmed described it as a “landmark moment for patients, researchers and our thriving life science sector”.

What do the reforms mean for patients?

“A key ambition of these reforms is to reduce delays in clinical trial set-up and enable treatments to reach patients sooner,” says Karima Lalji, a primary care pharmacist and research unit manager at Hammersmith and Fulham Partnership Primary Care Network.

“Faster regulatory approvals have the potential to accelerate access to innovative therapies, while allowing researchers to generate evidence more efficiently.” 

However, she warns: “Achieving these ambitions depends not only on regulatory processes but also on having research-ready environments that can identify, recruit and support participants effectively.”

Lalji says the reforms will mean the trials will be more valid and increase participation. “Many patients receive the majority of their ongoing healthcare within primary care, and bringing research into these settings can reduce barriers to participation, improve convenience and support greater diversity within trial populations,” she says.

“Pharmacists can help patients understand research opportunities and provide continuity throughout their research journey.”

Amira Guirguis, chief scientist at the Royal College of Pharmacy, agrees the legislation “will help ensure the evidence generated is relevant to the diverse populations who will ultimately receive these treatments”.

She adds it will be important that faster trial set-up times translate into wider and more equitable access to research opportunities, including for patients in community, primary care and historically underserved settings. 

Joanna Jenkinson, director of research and development policy at the Association of the British Pharmaceutical Industry, describes the legislative changes as “a significant step” for patients.

“The reforms also strengthen transparency, meaning there will be clearer information about trials and their impact, raising the already high standards of transparency that industry adheres to,” she says. 

Paolo Beghini

What do the reforms mean for pharmacists?

The new regulations state that healthcare professionals can act as investigators and chief investigators for trials, as long as they have appropriate qualifications, experiences and training, and are supported by medically trained professionals if they do not have a medical qualification^​1​. This includes pharmacists, doctors, nurses, dentists, optometrists and other professionals registered with the Health and Care Professions Council.

The legislation defines an investigator as “the healthcare professional responsible for the conduct of a trial at that trial location” or if the trial is conducted by a team of healthcare professionals, “the leader responsible for that team”^​1​.

Meanwhile, a chief investigator (CI) is defined as either the investigator for a trial conducted at one location; the person who takes responsibility for the conduct of a trial, whether or not they are an investigator at a particular location; or the investigator who coordinates other investigators at the different investigator sites participating in a multicentre trial^​1​.

Guirguis says while the reforms “recognise the important contribution [pharmacists] can make to research and leading clinical trials”, there must be workforce capacity for pharmacists to take up these roles. 

“As with any significant change, successful implementation will depend on ensuring the workforce has the capacity, training and support needed to take advantage of these opportunities while maintaining the highest standards of patient care.”

Cathrine McKenzie, professor of intensive care pharmacy and honorary consultant pharmacist in critical care at the University of Southampton — and chief investigator of the DELTA-ICU trial — says she hopes the changes mean “more pharmacists lead clinical trials of investigational medicinal products in medicines optimisation [as] medication therapy is very complex, burdensome and can be unnecessary”. 

In the NHS, pharmacists are heavily involved in medicines optimisation teams, in which they are responsible for factors such as problematic polypharmacy, antimicrobial resistance, variation in access to effective treatments, medicines sustainability and the safety of high-risk medicines. 

However, McKenzie believes it will take longer for pharmacists and other non-medical colleagues to become investigators for trials with complex clinical settings or trial designs. “This is because, in my view, when medical doctors become consultants, their role is to lead the clinical decision process for a patient under their clinical care. Non-medics, including consultant pharmacists, feed their view into these clinical decisions. 

“In a CI role, one has to evolve into making decisions — and a lot of them — for sometimes a big randomised controlled trial over many professional groups and [that] impacts all trial participants. I think it takes us longer in our career research, clinical or otherwise, to reach this.” 

What do the reforms mean for pharmacy technicians?

Changes to supervision legislation, due to come into effect on 10 December 2026, mean pharmacists can authorise pharmacy technicians to perform tasks that would otherwise be performed by a pharmacist or under their supervision. Under these changes, both pharmacists and pharmacy technicians must meet other requirements for clinical trials (see Box). 

As a result of the changes, pharmacy technicians will be able to supervise the assembly of investigational medicinal products in clinical trials, if authorised by a pharmacist. 

Lalji says this will allow “the wider pharmacy workforce to contribute to research delivery while pharmacists focus on clinical oversight, participant safety and investigator responsibilities”.

Paolo Beghini

Could new roles for pharmacists be created?

Guirguis says she does not foresee new jobs being created because of the reforms, but rather that they will create “new leadership opportunities”.

However, she adds that “these additional responsibilities should not simply be absorbed into an already stretched workload”. 

“Pharmacy teams will need clear governance, defined roles, appropriate training and protected time to ensure research involvement is safe, sustainable and meaningful,” she says.

Lalji agrees, arguing that the necessary resources must be put in place to allow pharmacists to take on new leadership roles. 

“As pharmacists take on greater investigator responsibilities, it will be important that study budgets reflect the true workload involved in delivering research. This includes recognising activities such as recruitment searches, patient communication, staff training, pharmacy set-up, investigational medicinal product management, governance requirements, data collection and follow-up,” Lalji says.

“In primary care, pharmacists frequently undertake activities that overlap with clinical research practitioner and clinical trial coordinator roles, including identifying eligible participants, supporting screening and recruitment, conducting clinical assessments, coordinating study activities, supporting follow-up and managing research documentation. These activities are essential to successful trial delivery but are not always fully recognised within existing costing models.”

How long will it take for the changes to have an effect?

Guirguis points out the impact of the legislative changes is “unlikely to be immediate”.

“While streamlining approvals should help clinical trials get underway more quickly, research still takes time to recruit participants, generate robust evidence and complete the necessary regulatory processes,” she says.

“These reforms lay the foundations for a more efficient system, with the benefits becoming clearer over time.”

Lalji says that regulatory changes to the clinical trials system “will not transform research delivery” on its own. 

“To fully realise the potential of pharmacist-led clinical trials,” she says, “we need investment in infrastructure, realistic costing and recognition of the roles pharmacists already play within research teams.”