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Last week, six men were taken seriously ill after volunteering in a clinical drug trial, carried out by Parexel, an American clinical research company. The volunteers were given a new anti inflammatory drug TGN1412 developed by German drug manufacturer TeGenero designed to treat rheumatism and leukaemia. Clinical negligence specialists, Alexander Harris who represent the family of a 28 year old in a critical condition at Northwick Park Hospital explains how clinical drug trials work.

Any newly developed treatment must go through clinical trials before they are granted a license in the UK. Before a license can be grated, a treatment must go through several stages of clinical trials (known as phases), and these will either involve healthy volunteers or ill patients.

The aim of the clinical trial is to ensure the new treatment is safe. It is also used to discover what side effects, if any, the new treatment has, and whether it positively benefits the health of ill patients. The clinical trial 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 be granted in the UK for a new drug, the manufacturer must obtain clinical trial authorisation (CTA) from the Medicine Healthcare Regulatory Authority (MHRA). Before a clinical trial can be authorised, the manufacturer must submit an application with supporting medical and scientific data to the MHRA. They must also obtain a positive opinion from an Ethics Committee, which is independent of the drug industry established and funded by the NHS. The supporting data partly consists of laboratory and animal testing and tests for toxicity. This data is then reviewed by the MHRA to determine whether the drug is scientifically valid and properly researched pre-clinical trial.

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, such as Parexel, whose units for the TGN1412 drug trial were based at Northwick Park hospital. These companies carry out clinical trials on behalf of the drug manufacturer i.e. TeGenero who developed TGN1412.

The clinical trial also has to be conducted in accordance with good clinical practice (GCP). According to the EU Directive 2001/20, article 1, clause 2:

Good clinical practice is a set of internationally recognised ethical and scientific quality requirements which must be observed for designing, conducting, recording and reporting clinical trials that involved participation of human subjects. Compliance with this good practice provides assurances that the rights, safety and well-being of trial subjects are protected, and that the results of clinical trials are credible.

There are four phases of a clinical trial for a new drug. Phase I looks at whether a drug is safe, whether it is has any side effects and what the appropriate dosage is. Clinical researchers will often recruit a small number of healthy volunteers for phase I research. Sometimes phase I research can require volunteers to spend two or three weeks in the research unit. Phase I trials are sometimes called early treatment trials.

Phase II trials test the new drug in a strictly defined group of ill patients to see whether it has any positive effects on their health. Phase II trials also look intensely at safety issues. The Association of the British Pharmaceutical Industry states that Phase II trials will often involve between 100 - 300 patients.

Phase III trials are only permitted when Phase I and II have suggested that a drug might actually be beneficial to ill patients. Phase III trials test the new drug in larger groups of ill patients which is more representative of the patient population. Phase III will also compare the newly developed treatment with the best known treatment available in the UK to help determine which treatment works better. The Association of the British Pharmaceutical Industry states that Phase III trials involved between 1000 - 5000 patients.

Phase IV happens after a drug has been licensed. This involves the assessment of the long term terms risks and benefits of the drug.

Alexander Harris are representing the family of a 28 year o areld in a critical condition following the TGN1412 drug trial.

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