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| home > epc > autumn 2003 > establishing the patient recruitment algorithm - should we apply a more heuristic approach? |
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European Pharmaceutical Contractor
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The continuing series of articles offering advice on how to improve the recruitment of patients into clinical trials confirms that patient recruitment remains one of the key challenges faced by the pharmaceutical industry. A critical and objective look at the topic might provide us with some clues as to why this should be so. Is it just a case of throwing solutions (and money) at the problem, or do we need to change the way we look at the whole issue?
Patient Recruitment and Retention in the Project Planning Stage
Clinical drug development seems to be all about numbers. Typically, a trial may begin with a proposition:
“Our new drug should show a 10 per cent improvement in efficacy compared to the gold standard and to demonstrate this, we must enrol 720 patients into our Phase III trial and produce evaluable data on 600 of them. Drug development timelines dictate that we complete enrolment within 12 months”.
An optimum number of investigator sites, let’s say 30, from which all the patients must be recruited will be determined so that by the time the study goals are filtered down to each Clinical Research Associate (CRA), he or she will be targeted with enrolling 24 patients in each of his sites within a 12 month period. Instinctively, the CRA sets himself an average enrolment target of two patients per site per month and plots a linear graph of planned recruitment over time (Figure 1).
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Industry Events |
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4th Annual Patient Recruitment and Retention in Clinical Trials
13-15 October 2008, Amsterdam
Patient recruitment
is now consuming thirty percent of clinical trial time - more time than any
other clinical trial activity - and almost half of all trial delays result from
patient recruitment problems.
As the
recruiting culture becomes more sophisticated and the forces affecting patient
enrollment grow more numerous and complex, pharmaceutical companies are
striving to discover new strategies to facilitate enrollment in clinical
trials.
With
increasing industry pressure to develop, test and market greater numbers of new
drugs faster, pharmaceutical companies need to perform clinical trials as
quickly as possible. Inefficient patient recruitment processes is a formidable
barrier to pharmaceutical companies' success in launching new products.
Improving the patient recruitment process is imperative to avoid wasted
investments and eliminate costly delays in bringing new drugs to market --
today and even more so in the not-so-distant future. Improved patient
recruitment presents one of the largest opportunities for pharmaceutical
companies to eliminate delays in clinical trials, thereby making it possible to
reduce time to market. With patent time limits and large overheads
meaning that any delays in the development timeline can be disastrous, a good
understanding of how to successfully recruit patients for trials is vital for
any company looking to succeed.
More info >> |
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