How to claim compensation for an injury from a clinical trial

If you've been adversely affected as a participant in a clinical trial, you may have grounds for a claim. Compensation can cover any unforeseen injuries or conditions that arise from trial participation, particularly when risks were not fully disclosed.

If your life, or the life of a loved one, has been affected by a clinical trial injury, we can help. You can make a No Win, No Fee compensation claim with the help and support of a specialist clinical negligence solicitor.

With over 13,000 clinical negligence claims a year, you're not alone

Every year, 1,000s of individuals participate in clinical trials across the UK, contributing to medical research and development. While these trials are typically conducted under strict safety standards, there are instances where participants may suffer injuries due to negligence.

Clinical trials are designed to test new treatments, drugs, or medical devices. Despite rigorous protocols, if a trial is negligently managed, it can lead to adverse effects on participants, ranging from mild discomfort to serious health complications.

A breach of the duty owed to patients taking part in a clinical trial can be the basis of a clinical negligence claim, a defective medication claim or a defective medical product claim.

13,511 new clinical negligence claims were referred to NHS Resolution in 2022/23 (resolution.nhs.uk).

Get an impartial opinion

To get impartial advice on whether you have a claim, speak to an injury claim expert on 0800 376 1001.

A brief phone consultation will tell you exactly where you stand. There is no obligation to start a claim.

How long do I have to start a claim?

If your injury is apparent immediately after medical treatment, you will have 3 years to start a claim.

It may be that the negligent procedure happened more than 3 years ago, but your injury was only diagnosed recently, within the last 3 years. If so, you may still be able to make a claim.

What if your injury was diagnosed months or years after treatment?

You may not be immediately aware of your injury. In some cases, months and even years can pass before symptoms appear.

The law allows you to make a medical negligence claim up to three years after the 'date of knowledge' (when you first learned of the injury).

It is recommended that you start a claim as soon as possible, as medical negligence cases can be complex. Starting your claim sooner will give your solicitor more time to gather medical evidence, assess the extent of your injury and to negotiate interim payments and your final compensation amount.

What are clinical trials?

Clinical trials are research studies on humans. They are designed to answer specific questions on how the human may respond or react to new medicines, drugs, treatments, medical devices and food.

A clinical trial is undertaken when there is a new drug or medication which has reached the final stages of testing and is about to be taken to the market.

The main aim of clinical trials is to ensure that new drugs and medicines are safe for use, and to see if there are any side effects.

Before the clinical trial can take place, the Medicine Healthcare Regulatory Authority (MHRA) must authorise the trial. Once the clinical trial has taken place with satisfactory results, the product can be granted a license.

Who takes part in clinical trials?

People usually volunteer for clinical trials.

Volunteers can be healthy or sick, and the trial often requests for volunteers within certain age groups and who fit certain criteria, such as within a certain weight bracket, or smokers and non-smokers.

Some potential claimants are concerned that they are not entitled to compensation because they volunteered. This is not the case.

A compensation claim may be made if a party that owed you a duty of care breached that duty and caused you injury that was reasonably foreseeable.

If you are unsure whether the circumstances of your claim will pass this test, contact a solicitor on 0800 376 1001 for more information.

Clinical trial phases

The four main phases involved in clinical trials are:

• The first phase tests the safety of the drug. Usually the drug is first tested on healthy volunteers to monitor for negative side effects. It will also assess the correct dosage of the drug.
• The drug is then tested on ill patients to see if the health of the patient improves. Ill patients will usually have the illness that the drug is aiming to cure or improve.
• Phase three tests larger groups of ill patients and compares the new drug with those currently in use to assess the effectiveness, and see which one works better.
• The final phase takes place once the drug has received a license, and is intended to look in to long-term risks and side effects, as well as the long-term benefits.

How much compensation can I claim for a clinical trials injury?

The compensation you're eligible to claim for illness or injury caused by a clinical trial depends on:

• the nature and severity of your injury,
• how your injury interferes with your daily activities and job,
• any financial burdens or costs arising from your injury.

General damages are awarded for pain, suffering and loss of amenity (PSLA). Awards for general damages are set by the Judicial College (judiciary.uk) and published in their guidelines for personal injury awards.

Special damages is compensation awarded to cover any financial losses and expenses you incur as a result of your clinical trial injury or negligent medical treatment. These damages aim to put you back in the financial position you would have been in, had your injury not occurred.

Special damages will also cover your medical treatment expenses, that might include corrective treatment and psychological support.

Read more:

A complete list of recoverable losses in a personal injury claim

How is compensation calculated if I have multiple injuries?

Do I qualify for clinical trial injury compensation?

Yes, you can claim compensation for a clinical trials injury or illness, if:

• you were injured in the last 3 years, and;
• another party was to blame, and;
• that party had a legal duty to protect you.

Use our injury claim calculator to find out if you can claim. Alternatively, you can speak to a claims advisor on 0800 376 1001 and find out if you have a claim in minutes.

How long do I have to claim clinical trial injury compensation?

For a clinical trial claim, you usually have 3 years to make a claim from the date you became aware that the harm you suffered was caused by substandard treatment (date of knowledge).

The 3 year limitation period does not apply to minors (under 18s). A parent, guardian or litigation friend can start a claim on a child's behalf up to their 18th birthday and the child has until their 21st birthday to claim for themselves.

Clinical trials injury clinical negligence claims

Clinical negligence is the most common basis for clinical trials injury claims. Click the icon below for details on the claims process.

Medical negligence Other accidents

Sources

Author:
Gaynor Haliday, Legal researcher

About the author

Gaynor Haliday is an experienced legal researcher and published author. She has had numerous articles published in the press and is a legal industry commentator.