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International Clinical Trials

Changing Ways

For many patients across a wide range of therapeutic areas, participation in a clinical trial can provide access to important life-saving medications. However, the efficient conduct of studies has long been complicated by complex protocols, inefficient recruiting methods and logistics that can make participation burdensome, if not impossible. Consequently, numerous trial sponsors, CROs, and clinical services companies are striving to facilitate patient access to studies while also making the trials themselves more patient-centric. In addition to improving recruitment processes and easing the burden of participation, such efforts are largely designed to enhance patient engagement before, during, and after the study.

While the challenges surrounding patient access, retention, and engagement are not new, surmounting these requires new approaches to trial design and administration. Already, some sponsors and CROs are incorporating patient input into study design to align clinical endpoints with patients’ priorities for health outcomes. On the legislative front, citizens and lawmakers in several US states are seeking to pass ‘right to try’ laws intended to enhance access to experimental drugs, especially for terminally ill patients. Nonetheless, such initiatives will not be sufficient unless they are accompanied by efforts that improve the patient experience.

Transportation Resolutions Historically, transportation costs have constituted a very small portion of clinical trial expenses. However, when patients lack reliable transportation, this can lead to noshows and dropouts, which significantly impact study costs and results (1). A National Research Council report identified inadequate transportation as a major contributor to a 30% dropout rate in Phase 3 trials, noting that the problem worsened over the course of lengthy trials (1,2). Factors such as travel distance and intensive trial-related testing schedules are often cited as barriers to participation, especially among patients considered for lengthier trials and the elderly, as well as for those with challenging disease profiles for whom transportation can be very difficult (3).

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Kurt Mussina brings more than 25 years of international business success to his role at Frenova Renal Research, including a record of leadership and achievement structuring and orchestrating global business development teams in the CRO industry. As Vice President, General Manager, he is responsible for building organisational alignment of functions to drive profit and research success. Kurt earned a Bachelor of Science in chemistry from Montclair State University, US, and received his MBA from Duke University, Fuqua School of Business, US.
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