Should patients be obliged to take part in research?



VIEWPOINT

Professor Anthony Mathur

Head of Advanced Cardiac Imaging at Barts and the London NHS Trust

Stem cells harbour huge potential for medical advance Not enough patients are volunteering to take part in ground-breaking stem cell research in the UK. In this week's Scrubbing Up, leading heart stem cell scientist, Professor Anthony Mathur, argues that if people want treatment for a heart problem, they should be obliged to take part in the research. Without doubt the future of medicine is dependent on clinical research that, in turn, relies on the willingness of patients to be exposed to new therapies. There exists an unwritten contract between society and medicine which acknowledges the interdependence of the two - the only way that important advances in medicine can be made is with the help of patients volunteering to participate in clinical trials. Unwilling patients However, our experience at a major teaching hospital in London is that as the nature of new treatments becomes more complex, the willingness of our patients to participate in these trials has decreased. Clearly a balance is needed given the tremendous potential benefits these new treatments could deliver for these conditions



Read your comments Our own experience of this phenomenon is the conduct of our stem cell trial designed for patients brought to us as emergencies suffering a heart attack. The possibility of using a patient's own stem cells to repair the damage caused by their heart attack could benefit the thousands of people suffering with this condition each year. Stringent laws and regulations are in place to ensure that trials of such new therapies are carefully conducted and the patient's health protected. Indeed the ethical process dictates that patients are given as much information as reasonable to make an informed decision to consent to the trial. The problem is that in the emergency situation there is an awful lot of information to convey in a short time to obtain 'informed consent'. 'Potential benefits' Clearly a balance is needed, given the tremendous potential benefits these new treatments could deliver for these conditions. In our stem cell trial, brief preliminary consent is obtained as the patient is treated for their heart attack. Invariably, the patient is keen to participate. Patients from more privileged areas are more likely to be recruited to our trial than those from the lower socio-economic environment

However, several hours later, following successful treatment of the heart attack, when the patient is approached to consent in full for the main part of the study, they often decline. Whilst this is understandable, given the relief the person must be feeling having been successfully treated for their heart attack, it creates a problem for the field of medical research which tries to improve on the success of modern medicine. Economic differences A further paradox exists. Patients in less economically privileged parts of the UK are more likely to suffer heart attacks and fare worse with them. Our small experience between two centres recruiting heart attack patients for our stem cell trials - one in the relative economic deprivation of the East End of London, the other in the affluent centre of London - shows that patients from more privileged areas are more likely to be recruited to our trial than those from the lower socio-economic environment. Added to this, is the observation that women in whom heart disease has previously been under-diagnosed, are also less likely to consent to the trials. It is difficult to find a straightforward solution to this dilemma. An individual human being must be given the right to choose whether to participate in medical research. However, there is also the need to advance medical discovery and strict rules and laws exist to protect the patient in this pioneering environment. 'New contract' Maybe a new contract is needed between medicine and society that assumes a default position that says that everyone attending hospital should be involved in medical research, unless they specifically opt out of the process at the time of consent? This approach has already been used in some European countries for organ donation and has led to a quadrupling in consent rates. Whatever the solution, the clinical trials await patiently those willing to put their faith in the system and hope for medical breakthroughs, if not for them, then for the benefit of others.

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