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International Clinical Trials

Human Touch

It is easy to lose sight of the trees when looking at the forest as a whole – just as some life sciences companies can inadvertently lose touch with patients when researching a breakthrough drug. But success depends squarely on the patient and on ensuring ready access to life-altering medications. Delays from slow-moving clinical trials chip away at a patient’s hope for a better tomorrow. Plus, there is no question today that time is money. Pharmaceutical businesses can lose as much as $8 million in revenue for every day that a drug is delayed from reaching the market (1). Due to this relentless time pressure – both for patients and profits – drug studies must progress at high levels of efficiency and precision to help deliver the most effective and up-to-date therapy in a timely fashion.

Recruitment Challenges


About 1.7 million patients participate in 80,000 drug company-sponsored trials globally per year (2). Yet researchers are increasingly struggling “to attract and retain the requested number of patients in order to complete [our] studies on time and within budget,” said Ken Getz, founder of the Center for Information and Study on Clinical Research Participation, a Boston-based non-profit organisation (2). Research results published in Clinical Trials: Journal of the Society for Clinical Trials earlier this year found that pharma firms spend on average more than $300,000 to enrol each participant in a Phase 3 clinical trial, amounting to almost 3% of a study’s total cost (3).

Despite this effort, nearly half of all sites (48%) miss their patient enrolment targets, with 11% of sites in a given study failing to attract a single participant and less than half of all subjects screened for clinical trials actually completing them (see full PDF for Figure 1) (4). While 89% of studies worldwide ultimately meet their recruitment goals, pharma organisations must nearly double their original timelines to achieve that result (5).

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As QuintilesIMS’s Vice President of Medical Affairs, Stewart Rosen develops medical educational models to aid patient health management through the management, training and deployment of medical science liaisons, clinical nurse educators and CTEs. He earned his medical degree from the Universidad Autonoma de Guadalajara, Mexico and completed his clerkship at Jamaica Hospital in Queens, New York.

As Regional Head of Operations, Nicola J Smith is responsible for operational oversight of field medical affairs projects across Europe and emerging markets. With more than 20 years of experience in healthcare, she joined the international team at QuintilesIMS in 2010 to provide leadership on complex multi-country medical affairs projects for both biotech and pharma customers.

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Stewart Rosen
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Nicola J Smith
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