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Are clinical trial volunteers properly protected by current safeguarding mechanisms?

Gene Matthews, Partner

Clinical trials conventionally take place before a new medical product is granted a licence in the UK. They are typically organised by pharmaceutical companies to test the safety, efficacy or side effects of new drugs and medical devices on humans.

The development of new drugs is crucial to us all in society.  The pharmaceutical industry enjoys multi-billion pound profits as a result of developing new products, the majority of which will have been tested on human volunteers. However, given their very nature, things can go wrong and participants have been known to be injured.

Where this happens, it is important to recognise the rights of individuals who become ill or who are injured as part of such development schemes.
 
Claims involving clinical trials are often legally distinct from other types of claim relating to medical treatment. Clinical trials are often run in accordance with the Association of the British Pharmaceutical Industry (“ABPI”) Guidelines. The guidelines require that injuries caused by clinical trial participation are compensated regardless of whether or not any negligence was involved.
 
The ABPI Guidelines make a distinction between Phase I clinical trials and those that are Phases II or III. Phase I clinical trials involve healthy volunteers who, clinically, have nothing to gain from the trial drug because they do not suffer from the condition the drug is being developed to treat. If they suffer side effects, they are entitled to ‘full compensation’. Phase II or III trials involve patients who suffer from the condition that it is hoped the trial drug will treat. They may, therefore, receive some benefit from the trial drug even if they suffer side effects. In those situations, compensation for side effects suffered will be reduced to take account of any benefit gained.
 
However, while they serve to protect volunteers, the ABPI Guidelines are simply guidelines. If a volunteer suffers harm as a result of a clinical trial, there seems to be no requirement that the guidelines are applied fairly and in a timely fashion.
 
Case Study

John (not his real name) took part in a Phase II trial in December 2015 for subjects with Hodgkin Lymphoma.
 
A week after receiving the first infusion of the trial drug, John started experiencing mild symptoms. He received the second infusion of the trial drug in January 2016 after which his condition quickly deteriorated. John was eventually diagnosed with transverse myelitis, an inflammation of both sides of one section of the spinal cord.
 
We received no substantive response from the trial sponsor between October 2016 to December 2017, except to acknowledge receipt of our communication. We then communicated directly with the Insurer between December 2017 and November 2018, and then with the Solicitors between December 2018 to May 2019. No substantial responses were received, and no progress was made to John’s case. 
 
Since our initial communication to the present day, John’s case has been passed between the trial sponsor, their Insurer and their Solicitors, causing delays and continuing the harm our client has suffered.
 
We have since had to protectively issue proceedings on behalf of John to protect his position in respect of limitation and may need to proceed his claim in the courts.

While the ABPI Guidelines have allowed some individuals to obtain compensation, they are not always adhered to and as a result some individuals suffer more harm and distress.  It is an unusual position for the pharmaceutical company that may have harmed an individual to be the same entity that decides when, if and how any compensation should be paid to the injured individual.  It is time this issue is carefully reconsidered by the Government to ensure clinical trial volunteers are properly protected as they intended.    

 

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