Clinical trials, by their very nature, involve an element of risk for both those undertaking or sponsoring the trial and those participating in it. These are after all, trials involving for example, combinations of pharmaceutical products not used in that combination, novel surgical techniques or drugs which have not been tried on human subjects previously. We consider some key medico legal issues arising from compensation claims associated with such trials.

Legal Background

It is essential that those designing the trial have adequate insurance. This protection not only offers security to those carrying out the trial that any losses or claims will be covered but also participants will know that any injury suffered will be properly compensated.  It is important to recognise need for participants to volunteer for clinical trials in order to achieve continued medical developments.

The Association of British Pharmaceutical Industry (ABPI) issued Guidelines upon how compensation for clinical trials should be handled. Because of the inherent risks involved, the majority of injuries will arise when there has not been any negligence on the part of the doctors or organisation running the trial. The normal tort regime of claims in negligence is therefore not sufficient to protect participants.  Likewise, claims are unable to follow the normal product liability claims route because products in a trial phase will not be deemed to be “defective”, because, by their nature, they are not yet fully tried and tested. 

The “no fault compensation scheme”

The ABPI Guidelines therefore outline a “no-fault compensation scheme”.  This means that there is no need for a participant who has suffered from an injury to show that this injury was as a result of negligence or a defective product. Instead they simply show that the injury was suffered as a result of their participation in the trial. All investigations are centred on causation, i.e. whether the injuries which are said to have been caused by the trial, were in fact caused by the trial or whether there is another explanation for these e.g. an underlying clinical condition. 

 There are some important exceptions and caveats within the guidelines, such as, if the side effect is something that has been consented for then this will, in certain circumstances, avoid the payment of damages, or minimise any payable. This is applicable on the consideration of two points;

1. the seriousness of the condition being treated and the potential benefit of treatment; and
2. the risks of the side effect.

The Guidelines specifically state that “… flexibility is required given the particular patient’s circumstances.  As an extreme example, there may be a patient suffering from a serious or life-threatening disease who is warned of a certain defined risk of adverse reaction.  Participation in the trial is then based on an expectation that the benefit/risk ratio associated with participation may be better than that associated with alternative treatment.  It is, therefore, reasonable that the patient accepts the high risk and should not expect compensation for the occurrence of the adverse reaction of which he or she was told”. 

Therefore, if the condition that the trial is seeking to address is serious, and the potential benefits of participating are significant, then the participant has to accept an element of risk. 

What does this mean for clinical trials?

This means that the consenting process for clinical trials is particularly important.  Whilst some side effects and symptoms are simply not going to be known, there will be many cases where the trial extends upon others, or uses combinations of drugs already well known. In such cases:

• risks should be clearly outlined and considered both in writing and in written discussions with participants;

• participants should be given adequate opportunity to consider the literature and discuss this with the trial team and their own treating clinicians;

• Those undertaking the trial must carefully consider the participants themselves and whether greater consideration needs to be given to the consenting process, i.e. what is their background and health history and will any side effects have a greater impact on this cohort of patients.  This may be a cohort of patients because they suffer an illness that the trial is attempting to treat, or it may be specific to an individual. 

Avoid ambiguity

Another challenge with clinical trials is the distance between the organisation sponsoring and managing the trial, and the treatment locations.  A trial may be sponsored and run by one organisation, but undertaken at various sites, such as hospitals, across the UK (or wider).  It is essential that trial policies and procedures, including participant eligibility criteria, are tightly drafted to avoid any doubt regarding what is expected of those remote sites.  Any ambiguity will create scope for variation at sites, which increases the risk of participant injury – as well as potentially undermining the study results.   

Key Practical Considerations

In summary whilst there will always be an element of risk in a clinical trial, all organisations should consider:

1. Who is the participant? – What is their history and what are their health needs;
2. Does this apply to the whole cohort or just a single patient;
3. What is the trial? – What are the potential benefits and what are the potential risks;
4. Does the participant understand the benefits and risks; how has this consent been obtained, and how has this been evidenced;
5. Where is the trial taking place, and who is undertaking this at participating sites; and
6. Are the policies and procedures in place tightly drafted so no variation from the trial can occur and all non-eligible patients are excluded

How can Capsticks help?

Capsticks advises underwriters, insurance brokers and a range of universities and medical and pharmaceutical organisations carrying out clinical trials on claims for compensation. For further information contact Majid Hassan or Ed Mellor.