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5 Aug 2013

Cohort size may have major impact on clinical trial budget

A new report indicates that clinical trial costs are closely tied to patient enrollment.

Pharmaceutical companies planning clinical trials in order to evaluate the efficacy of new drugs can more accurately forecast costs by carefully controlling patient enrolment.

Monitoring and restricting the size of the cohort will allow experimenters to avoid exceeding their budget, thus better enabling continuation of the investigation and investment elsewhere.

Cutting Edge Information released a report entitled Oncology Clinical Trials: Drug Development Resources and Case Studies detailing the link between trial expenses and patient enrolment.

The correlation may be stronger than anticipated, meaning that researchers may not be fully considering the impact of participant recruitment when evaluating costs.

According to the report, a phase 1 clinical trial involving 40 or fewer patients cost on average US$2.7 million, while the expense rockets to US$7.6 million when more people are enrolled.

Research leader at the organisation Ryan McGuire said: "The expected patient enrolment helps a clinical program leader gauge the total cost of the trial."

Since the cohort required to conduct reliable phase 2 and 3 clinical trials tends to be higher, this level of investigation is typically more expensive and budgeting meticulously is crucial.

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