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Establishing the Patient Recruitment Algorithm - Should we Apply a more Heuristic Approach?

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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By Tom Ruane, Director of Patient Recruitment & Retention at Quintiles

Tom Ruane has over 14 years' experience in international clinical development activities. Having enjoyed a variety of roles with various pharmaceutical companies and CROs, as well as the National Health Service, he is now Director of the patient recruitment and retention team at Quintiles.

The team maintains a strong focus on identifying potential patient populations, while devising and executing appropriate recruitment and retention strategies for clinical trials. Tom regularly presents at international meetings on the subject of clinical trial patient recruitment.

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Tom Ruane
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