International Clinical Trials Day

 

On This Day in History

May 20th marks International Clinical Trials Awareness Day, in commemoration of Dr James Lind, a British naval surgeon, who on or around this day in 1747 set up the first ever clinical trial. Following a lead from a German physician named Johann Bachstrom, James Lind set up a trial in British seamen to try and definitively prove if eating citrus fruits could prevent and treat scurvy, a debilitating condition caused by a lack of vitamin C.

James_Lind_by_Chalmers

Dr James Lind

The sailors of yesteryear would spend many weeks at sea and their diet would compromise mostly meat and carbohydrates as these tended to be a lot less perishable than fruit. As a result sailors would often succumb to scurvy, which if left untreated was fatal. In fact, in those days more sailors died from scurvy than in battle. Needless to say the trial managed by Dr Lind was roaring success and it soon became normal practice to give British sailors lime juice as a vital source of vitamin C.  The rest is history shall we say, as the nickname “limeys” has been “affectionately” used to describe those of British origin ever since.

 

Clinical Trials in The Modern Era

Although things may have moved on from those distant heady sea-faring days, the significance of clinical trials in medical research has never been greater, especially within the field of oncology, with a constant stream of promising drugs and new treatment strategies being continually introduced. A cancer clinical trial is where people/patients volunteer to participate in studies designed to carefully test new drugs or novel innovative methods that have been developed for the treatment, prevention, screening or diagnosis of cancer. These trials can take place in a variety of settings from GP surgeries, hospitals, community clinics or specialised cancer centres such as Velindre in Cardiff, all offering a safe and controlled environment.

Clinical trials are managed in steps, commonly referred to as phases, with each one building from the previous.  The first step known as Phase I access the safety and toxicity of a drug in order to find the right dose that can be taken forward to a Phase II trial. These recruit larger number of patients, often in the region of 60-100, to directly assess the effectiveness of a drug or intervention on disease. If Phase II results prove promising, definitive Phase III trials are then designed so that the true efficacy of promising new treatments can be determined. Phase III trials are often multicentre and global in nature and recruit hundreds of individuals who are then split into groups called treatment arms, where they receive one treatment or another.

The once commonly held, yet misinformed notion that patients involved in clinical cancer trials were essentially no more than guinea pigs, is nowadays literally non-existent, with the majority of patients surveyed stating they would definitely consider participating in a suitable trial if asked. The reality is that the minimum level of care most patients entering clinical trials will receive is the best standard treatment available at the current time for their stage of disease. Unlike those participants in Dr Lind’s pioneering trail for scurvy who were forced to either drink one quart of sea water, or gaggle on sulfuric acid daily, so that true comparisons could be made with those lucky enough to receive oranges and lime juice. Although, I guess in the short-term, those seamen receiving cider in another one of Dr Lind’s six treatment wouldn’t have complained too much.

 

Clinical Trials Unit Velindre

The Clinical Trials team at Velindre

Cancer Clinical Trials in Wales

Clinical trials is a critical component of cancer research and as such the Welsh Government continues to make this a priority area as it encourages all regional health boards in Wales to offer every patient equitable access to relevant clinical trials where appropriate. In recent years Wales has developed a strong platform for the development of oncology related clinical trials with the establishment of the Welsh Clinical Trials Unit at University Hospital of Wales and the growth of the clinical trials unit at Velindre Cancer Centre in Cardiff, which first launced in 1994. More recently the trials centre at Velindre has opened a Phase 1 unit, which offers Welsh cancer patients, early access to the very latest cancer treatments. Before this patients from Wales would have to travel to places such as Birmingham to take part in a brand new exciting trial.

Indeed there has been much to celebrate already, with Wales contributing more patients to the STAMPEDE prostate cancer trial than any other country. A trial overseen by Cancer Research Wales’ very own Professor Malcolm Mason. Hopefully, this will serve to attract future lead academics and pharmaceutical companies to Wales which will serve to benefit Welsh cancer patients.

Professor Malcolm Mason

Professor Malcolm Mason

Cancer Research Wales has been a long-standing supporter of the clinical trials unit at Velindre where it funds specialised research nurses and data managers. Research nurses provide the continued and all important caring and compassionate interface between the patient and the doctor or drug company as they stand side by side with the patient throughout the trial. While data managers, have the no less essential task of collating the masses of information that is generated during a clinical trial. It is only as a result of the continued generosity of our supporters and volunteers across Wales that we are able to provide local oncologists and research nurses with the opportunities to lead practice changing research through local clinical trials.