The new UK clinical trials regulations: Where does the new law leave injured trial participants?

On 28 April 2026, the Medicines for Human Use (Clinical Trials) Amendment regulations 2025 came into force, marking the most significant change to the legal regulation of clinical trials in the UK for more than two decades. 

Clinical trials play a vital role in the development of new medicines, medical devices and procedures.  They are regarded by many as one of the only reliable means of testing the safety and efficacy of medical breakthroughs before they are approved for wider use in other patients and producing what the medical industry refers to as “real world data”.   

Last year over one million participants took part in clinical trials across the UK, whether as part of their existing NHS or private healthcare treatment, or as paid medical trial volunteers.  

Since 2004, clinical trials in the UK were regulated by the Medicines for Human Use (Clinical Trials) Regulations 2004, which set out detailed requirements governing trial approval, ethical review, consent, safety reporting and trial sponsor responsibilities. Whilst the 2004 framework was designed primarily to improve the safety of patients involved in these clinical trials, it did not include any provisions about whether and how individuals should be compensated if they were injured as a result of taking part in a clinical trial.  

Whilst adverse events associated with clinical trial participation are considered rare, it should not be forgotten that history has repeatedly shown us that things sadly can and do go wrong for trial volunteers.  Unexpected harms to the patient can arise not just in respect of an adverse reaction or outcome from the novel drug or device itself, but also in respect of how it is administered and any associated treatment or care that goes with it. 

Trial participants are often encouraged to participate with the promise that if they are injured whilst taking part in a clinical trial they would be entitled to compensation without having to prove fault, via what are known the “ABPI Clinical Trial Compensation Guidelines” (“the ABPI Guidelines”).  The ABPI Guidelines suggest that an injured trial participant does not have to prove that the drug or product that harmed them was defective or that they were the subject of any negligence as would be required in a product liability or clinical negligence claim. 

In practice, however, drug companies responding to such claims regularly instruct city lawyers to argue that the ABPI are only voluntary and therefore not legally binding in any way.  Arguments are also regularly run in defence of such claims in respect of whether participation in the trial caused or contributed to the individual’s injuries and losses.  They also point out that a closer reading of the ABPI Guidelines includes provision that no compensation is payable if there was a “reasonable prospect of direct benefit” to the individual. 

This approach can make it even more difficult and daunting for an injured trial participant to seek redress.  It gives rise to the need for them to seek very specialist legal advice to help navigate and understand the novel medicine. These individuals ideally need the help of Solicitors who have both product liability and clinical negligence experience which can be hard to find. 

It is no secret that clinical trials generate large profits.  The ABPI recently reported that clinical trials brought £7.4 billion of gross added value to the UK economy in 2022 with £1.2 billion revenue to the NHS.  Despite these financial results, the ABPI have suggested that the UK needs to do better and that reform to the regulatory system is long overdue if it is to restore its competitiveness with other countries in order to return to one of the top destinations in Europe for the delivery of clinical trials.    

For many years, the 2004 framework attracted criticism within the pharmaceutical industry for being rigid and administratively burdensome, with concerns that it slowed the initiation of trials and placed unnecessary obstacles in the way of medical research. These criticisms eventually caught the ears of the UK government, and a decision was made to commence work in modernising and reforming the existing framework.   

The Medicines for Human Use (Clinical Trials) Amendment regulations 2025 appears to have responded to the industry’s concerns by introducing a new regulatory regime for clinical trials in the UK which is intended to streamline the approval and regulation of trials, reduce duplication between regulatory bodies, and make the UK a more attractive environment for clinical research.  Key elements include: 

• A streamlined approval process for clinical trials: one combined review process which now implements both ethics and regulatory committee approvals. 

• Risk-proportionate regulation, where what are deemed as “low-risk” trials will receive faster approval via automatic authorisation. 

• The requirement for clinical trials to be registered on publicly accessible public registry. 

Very little is yet known about how the new Regulations will work in practice, but the UK government has been clear that these reforms are intended to promote innovation in a more agile system without compromising participant safety.   

It is disappointing, however, that there appears to be no provisions at all relating to whether and if so, how trial participants should be compensated if things go wrong.   Injured individuals therefore have the same legal hurdles to overcome that they have been in place for many decades. 

With the advancement of robotics and artificial intelligence in medicine that we have started to see, it is ever more pertinent that the individual rights of the patient should remain paramount.  If the new Regulations succeed in attracting more clinical trial investment in the UK with the resultant effect that more novel medicines and devices are trialled here, it should not be forgotten that it is the individual trial volunteer at the centre of this process and they should be properly compensated if they are injured as a result of their participation in a clinical trial.  It is, of course, in a clinical trial company’s purview to provide unequivocal guarantees to new trial participants during the consenting process to this effect which could and should be adopted across the board. 

The specialist clinical trials team at Anthony Gold LLP have extensive experience of representing individuals who have been seriously injured in clinical trials.  Previous experience includes: the TGN1412 Northwick Park Drug Trials case, reported widely as the “Elephant Man Drug Trial”  (a Phase I clinical trial for the anti-CD28 monoclonal antibody TGJN1412 which was intended to treat leukaemia and other diseases like rheumatoid arthritis which caused life-threatening cytokine release syndrome in 6 healthy trial volunteers) and other confidential trials including: a new drug for severe Haemophilia A causing widespread neuropathy,  novel medical device for the treatment of macular degeneration causing blindness, novel medical device for small bowel enteroscopy causing oesophageal laceration.

Clinical trial claims – frequently asked questions

Clinical trials are essential to the development of new medicines, treatments and medical devices. They depend on individuals being willing to take part in medical research that may benefit others in the future. 

However, taking part in a clinical trial does not mean you give up your legal rights. If you are injured during a clinical trial, you may be entitled to compensation. 

What is a clinical trial?

A clinical trial is a research study involving patients or healthy volunteers. It is designed to test new medicines, medical devices, treatments or different ways of delivering healthcare. 

Clinical trials are usually run or sponsored by pharmaceutical companies, universities, research institutions or NHS trusts, and must receive regulatory and ethical approval before they begin. 

Can I claim compensation if I am injured during a clinical trial? 

Yes. Being injured during a clinical trial does not prevent you from bringing a claim. 

If injury occurs as a result of negligence — such as poor clinical care, failures in consent, or a failure to follow the approved trial protocol — you may be able to bring a clinical negligence claim in the usual way. 

Do clinical trial participants have the same rights as other patients?

Yes. Clinical trial participants remain patients and are entitled to reasonable standards of care. Doctors, nurses and other healthcare professionals involved in trials continue to owe duties of care. 

Participation in research does not mean that lower standards apply or that injury must simply be accepted. 

What kinds of injuries can give rise to a claim?

Claims may arise where injury results from issues such as failures in consent, inadequate monitoring of side effects, failure to respond to adverse events, departures from the trial protocol, or negligent clinical treatment provided during the trial. 

Not every adverse outcome will amount to negligence, and each claim depends on its specific facts. 

Do I have to prove negligence to obtain compensation?

Not always. There are two principal routes to compensation. 

The first is a clinical negligence claim, where breach of duty and causation must be established. 

The second is through voluntary no-fault compensation schemes, such as those operated under the ABPI Guidelines, which may apply even where negligence cannot be proven. 

Has the law on clinical trials recently changed?

Yes. From 28 April 2026, the UK’s regulatory framework for clinical trials changes for the first time in over 20 years. The new regime is designed to modernise and streamline clinical trials regulation. 

Importantly, these changes do not remove patients’ rights to pursue compensation if they are injured. 

Who can be responsible for a clinical trial injury?

Depending on the circumstances, responsibility may rest with a pharmaceutical company, an NHS trust, individual clinicians, or more than one party. Identifying the correct defendant can be complex and often requires specialist investigation. 

Is there a time limit for bringing a claim?

Yes. Strict time limits apply, usually beginning on the date of injury or the date you became aware that the injury may be related to the clinical trial. Different rules can apply to children or those lacking capacity. 

How Anthony Gold LLP can help

We act exclusively for injured claimants in clinical negligence and serious injury matters. Our team has experience handling complex and unusual claims, including those arising from clinical trials. We provide clear advice, careful investigation and a sensitive, claimant-focused approach.