Clinical trial error claims
Our medical negligence solicitors specialise in pursuing claims relating to clinical trials negligence. Our experienced team has won many of these claims, recovering substantial damages for our clients on a 'no win, no fee' basis.
If you or a loved one has been injured as a result of a clinical trial and believe that you may have a legal claim, contact us for advice.
Call Freephone 0800 358 3848
If you or your family have suffered due to error in a clinical trial, our specialist team of solicitors can help you recover the compensation you and your family deserve, Call us today or start your claim online and we will call you back.
What are clinical trials?
Clinical trials take place before a new drug is granted a license in the UK. The new drug must go through several stages of clinical trials (known as phases) before a license can be granted. Clinical trials may also take place when a new combination of drugs is being tested in comparison with a licensed drugs to see if improved results can be achieved. Clinical trials will either involve healthy volunteers or ill patients.
Clinical trials aim to ensure that a new treatment is safe. They are also used to discover any side effects associated with a new treatment, and whether the new treatment positively benefits the health of ill patients. Clinical trials will also compare the newly developed treatment with the best known treatment available in the UK to help determine which treatment works better.
Before a clinical trial can take place in the UK for a new drug, the manufacturer must obtain clinical trial authorisation (CTA) from the Medicine Healthcare Regulatory Authority (MHRA). Once clinical trial authorisation has been obtained for a new drug, a clinical trial can then be commissioned to medical/academic institutions, as well specialist clinical research companies.
There are four phases of a clinical trial of a new drug:
This phase involves looking at whether a drug is safe, if it has any side effects and the appropriate dosage to prescribe. Clinical researchers will often recruit a small number of healthy volunteers for Phase I research.
This phase of the trial tests the new drug on a group of ill patients to see if it has any positive effects on their health. Phase II trials look intensely at safety issues.
These trials only take place when Phase I and II trials have suggested that a new drug may be beneficial to ill patients. Phase III tests the new drug in larger groups of ill patients, which is more representative of the patient population. This phase also compares the new treatment with the best known treatment available in the UK to help decide which treatment works better.
Phase IV happens after a drug has been licensed. This involves the assessment of the long term terms risks and benefits of the drug.
Compensation in clinical trials
Compensation in clinical trials is governed by the EU Clinical Trials Directive implemented in the UK by the Medicine for Human Use (Clinical Trials) Regulations 2004.
Neither this Directive nor the UK Regulations require no fault compensation in clinical trials but the Association of British Pharmaceutical Industry Guidelines for medical experiments in non patient human volunteers (March 1988) offer such a compensation scheme at the manufacturers discretion.
In the event that compensation under an such an indemnity cannot be agreed, then the injured patients will have redress either at common law in a claim for negligence or alternatively in relation to the defective product under the Consumer Protection Act 1987.
Factors which are unknown which will have a bearing on this failed medical trial will be
- The relationship of the clinical trial to the non human experimental protocol to date
- The nature of the protocol approved by the relevant Research Ethics Committee
- The question of whether or not the clinicians supervising the trial adhered sufficiently closely to the protocol
- Whether there was some drug effect even when that protocol was wholly adhered to, which was incapable of being anticipated by the manufacturer
For further information or if you believe you have suffered as a result of a clinical trial, please contact us.
Contact us on freephone 0800 358 3848
Or start your claim online.
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