Clinical trials compensation claims
This guide considers what you need to know about making a clinical trials compensation claim.
It is likely you will be able to claim compensation if you have taken part in a clinical trial that:
- resulted in the worsening or development of illness or injury, and
- the injury was due to the negligence of another party, and
- that party owed you a duty of care
The body responsible for the trial should have insurance in place to cover the cost of compensation claims.
A breach of the duty owed to patients taking part in a clinical trial can amount to clinical negligence, or may relate to defective medication or defective medical products.
Clinical trials are research studies on humans. They are designed to answer specific questions on how the human body 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.
I have a strong claim - why won't a solicitor take it on?
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 612 7456 for more information.
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.
The vast majority of clinical trials are safely administered. By the very nature of clinical trials, however, there remains the possibility that a patient could experience adverse effects.
Determining whether a personal injury claim can be made will depend on the cause of these adverse, injury-causing effects.
Clinical trials regulations
In the UK, the Medicine for Human Use Regulations (2004) implemented the EU Clinical Trials Directive.
The regulations state that there is no automatic compensation scheme available if you have been injured in a medical trial.
However, there are several rules and other pieces of legislation in force that apply to clinical trials and confirm that there may be a claim if the trial is found to have breached these regulations.
A lawyer will consider the regulations governing the trial, and if they have not been adhered to, make an appropriate claim on your behalf.
If a claim cannot be made via this direct route, your lawyer could also consider a clinical negligence claim or a defective product claim. You solicitor will be able to advise you on the best route for you, dependent on your circumstances.
A No Win, No Fee agreement, referred to as a CFA or Conditional Fee Agreement, is the beginning of a personal injury claim.
A CFA details the service the solicitor will provide, and importantly, a percentage-based "success fee". This will be the percentage to be taken from the compensation when the solicitor wins the claim.
You have absolutely no hidden fees when choosing a Quittance solicitor. You can prioritise your rest and recovery, knowing that there will be absolutely nothing to pay at the outset.
A free Compensation Claim Report (CCR) includes an in-depth look at possible compensation, the length of time the claim could take and the chance of achieving a successful outcome.
Your Compensation Claim Report will include much more detail on the key points of your claim.
The amount of compensation you will receive depends on a number of factors. Our medical negligence compensation calculator provides an accurate estimate of your likely compensation.
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About the author
Paul is a member of the Law Society Personal Injury Panel, a member of the Association of Personal Injury Lawyers, and has served as a Deputy District Judge, giving him a uniquely broad understanding of the claims process.
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