Clinical Trial Claims *
Clinical trials are research studies which are carried out on people in order to answer questions on how the body could respond or react to new medication, treatments and medical devices. This medical research is carried out when a new medication or drug has reached the final stages of testing and is just about to be taken into the market. This testing is used to ensure that this new medication is safe for use and also allows manufacturers to determine if there are any side effects associated with its use. This clinical research cannot take place until it has been authorized by a healthcare authority.
In most cases, it is people from the age of eighteen who can take part in clinical trials, people usually volunteer for this. Participants do not have to be healthy to take part. In some cases there are certain criteria which you must meet before you can participate. This can be a specific age group, weight bracket or general health of a person. If you have sustained an injury or developed an illness as a result of participation in a clinical trial you may be entitled to make a claim * . It is important to note that this is also the case if you have volunteered to take part. Although most of these trials are carried out in a safe manner there is still a change that an injury or illness may be sustained. Many of these illnesses are unavoidable as this can often go with the nature of clinical trials and testing. Injuries which can be sustained will vary and can have different effect on individuals who are taking part.
Clinical Trial Phases
In most cases there are four main phases associated with clinical trials.
- In the first phase the safety of the drug is tested. In most cases it is tested on healthy participants in order to monitor the negative side effects which the drug may have. At this stage the correct dosages can also be assessed.
- The second stage is when the medication is tested on sick patients. This allows them to assess if the drug improves the health of a patient. In order to assess this, the participant will need to have the illness which the drug can be used to treat.
- At this stage the new medication is tested on larger groups of sick patients in order to compare it with drugs which are already on the market. This is used to show the effectiveness of the new drug and to determine which works better.
- This is the final phase of clinical trials which is carried out when the drug has received a licence. This stage of testing looks at long-term side effects and benefits associated with the medication.
Health Products Regulatory Authority (HPRA)
The role of the HPRA is to protect and enhance the health of the public through the regulation of medicines, medical devices and any other health products. They are also responsible for the assessment of clinical trials relating to medical products in Ireland. Currently in Ireland, clinical trials are governed by the European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004. These regulations state that in order for a clinical trial to take place it must first be authorised by the HPRA to ensure that it follows the correct procedures along with health and safety regulations. Outlined in these regulations is the steps which must be taken in order to request a clinical trial and also how it should be carried out to ensure the health and safety of all participants and volunteers.
- Deterioration of existing medical condition
- Severe side effects leading to injury and illness
- Development of an illness as a result of medication tested
- Incorrect treatment given to those who are unwell
TELL US ABOUT YOUR CASE
If you would like more information on this topic or the process of making a claim for clinical trial errors *, feel free to contact our solicitors on 01 649 9900 or email email@example.com for a confidential discussion.
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