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International Clinical Trials

Public Perception

If you asked the ‘man on the street’ which industry they think has a current turnover of over $20 billion per annum, is worldwide, and is expanding at over 5% per annum, few would answer 'outsourced pharmaceutical research'. The total market for clinical trials is perhaps double this, but, for most people outside the development end of the drug industry, clinical trials are invisible – until something goes wrong, of course. Many still remember the press headlines about the TeGenero affair, where, in 2006, a Phase 1 clinical study was conducted for a CD28 superagonist antibody TGN1412 in six human volunteers. After the very first infusion of a dose 500 times smaller than that found safe in animal studies, all six human volunteers faced lifethreatening conditions involving multiple-organ failure for which they were moved to the intensive care unit. Such incidents are extremely rare, one might say fortunately, but fortune plays little part in the safety record of early clinical trials. Indeed, regulations have since been tightened. This is one area where the so-called nanny state has worked. The control of clinical trials in the 21st century has become extremely tight – especially when the situation is compared with how it was in the late 1980s. No legal control of trials existed in the UK and much of the rest of Europe; ethics committee approval was all that was needed, but, even so, very few accidents occurred.

Over the years, patient recruitment and retention have always been a challenge. Elsewhere in this edition, authors comment on patient centricity in trials that may go some way to helping research sites to retain patients once they have been recruited. Public ignorance of trials and their strict regulations are part of the problem. Generally, the first time that a person comes into contact with a trial is when they become a patient. That is hardly the best time to be making a decision that, in Europe at least, is likely to be altruistic or, in the case of trials in life-threatening diseases, a desire to participate in something that might just save your life. In the US, up to 30% of the population do not have a primary care physician and are essentially lost to the traditional recruitment process even though they may get free healthcare (and follow up) as a result of their participation. Clinical researchers also find that patients, once approached to take part in a trial, are often reluctant to enrol because of the data and personal details that they must, by regulation, share with the sponsor. However, most are still willing to share similar data with social media sites and by default ‘friends’ or in the worst case scenario, the hackers of these sites.

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Dr Graham Hughes
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