Clinical trials
There are two compensation schemes available to patients/individuals who sustain an injury after participating in a clinical trial.
When you participate in a clinical trial, you may often wonder about the insurance that will apply in the event that you are unlucky enough to sustain an injury.
Two compensation schemes
No ordinary insurance applies, but there are two compensation schemes that may be relevant. NPE is responsible for both schemes and investigation of claims is free:
- drug insurance scheme
- patient injury scheme
The drug insurance covers injuries caused by the clinical trial, i.e. adverse reactions to the drug, procedures relating to the clinical trial or other related treatment.
The patient injury scheme covers patient injuries sustained during clinical trials and for which treatment failure has occurred.
The schemes may occasionally overlap and it is not always easy to know where a claim belongs. We can help you with this.
Selecting the claim form
If you are unsure which claim form to complete, it would be best if you select NPE's own form or call us for advice. We will ensure the correct investigation of the claim and will involve those responsible for the clinical trial.
Persons who need medical treatment participating in clinical trials
Both healthy persons and patients who are ill participate in clinical trials. Recruitment often takes place as a result of you already being in contact with the health service due to being ill. In such cases, the clinical trial participation will normally form part of the ongoing treatment. If this is the case, and you sustain an adverse reaction injury that you could also have sustained from ordinary treatment, you may not be entitled to any compensation. This will depend on a comprehensive assessment of several factors. According to the law, emphasis must be placed on how important the treatment was to you, whether you had any vested interest in participating in the clinical trial and whether the drug had any positive effect.
If, for example, you have a serious type of cancer and receive treatment by participating in a clinical trial and become cancer-free, you will normally be expected to accept adverse reaction injuries that are known and that you may also have sustained through ordinary treatment.
Healthy persons participating in clinical trials
If you are healthy and participate in a clinical trial without any vested interest in the outcome of the drug treatment, you will normally be entitled to compensation for adverse reaction injuries. If, for example, you have developed an uncomfortable rash that results in costs for e.g. ointment, etc. you would normally receive compensation for this.
Statistically, there is thankfully little additional risk associated with participation in clinical trials compared to receiving ordinary drug treatment. If your claim falls under the drug insurance scheme, you may receive compensation for financial loss from the first krone. However, if your claim falls under the patient injury scheme, the condition for compensation is that you must have suffered a loss of at least NOK 10,000 or have sustained permanent injury of at least 15 percent.