How to enable a patient with a busy life to enrol in a clinical trial
Enabling apatient with a busy life to enrol in a clinical trial
A new feature for this year’s Pain Clinic was the addition of a case study examining how to enable a patient with a busy life to enrol in a clinical trial.
A 64 year old female with a history of aortic valve replacement. The existing valve was now failing causing extreme fatigue and shortness of breath.
As this lady is the wife of a racehorse trainer, exercising and caring for racehorses every day, plus running a catering service it was essential to return her to full fitness as soon as possible. Her first aortic valve replacement was through open surgery entailing a long recovery period including a stay in intensive care. Following a week in hospital there still remained a lengthy recuperation affecting her lifestyle and ability to work.
Her awareness of her condition and its effect on her ability to function at full capacity meant that she would be interested in research to improve treatment.
However, her work requirements were not compatible with multiple visits to a clinical site. Travel arrangements would be difficult, she was unable to be away from home for trial visits and when working with animals, their care is the priority.
She was fortunate in that her consultant at the Hammersmith was pioneering the TAVI procedure in the UK. She remained awake during the procedure, which also meant that the surgeon could explain every aspect of the procedure. She was discharged 36 hours later.
If trials were available utilising mobile technologies to collect data, and video consultations to minimise visits to a clinic this would enable patients such as this to participate in clinical trials. These are the very people who are needed but the rigid Protocol requirements, numerous site visits and the impact on their work prevent them from enrolling.
This lady is aware that her procedure is new and the data is not available yet on how long her valve will last. She would be happy to take part in trials that were compatible with the demanding requirements of her daily life.
This item created a great deal of discussion. Clinical Trials Europe is fortunate in the wide range of companies exhibiting, and many of these were kind enough to offer practical solutions. As nurses, Olivia and I recognise that many patients that could be enrolled in trials are prevented from doing so by the Protocol requirements and study design. This is detrimental to the quality of data collected.
Problem Solving eBook
Another feature that proved popular was The Pain Clinic Problem Solvingebook. All the hard copies available were quickly snapped up, but you can read the digital version here.