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International Clinical Trials

Optimising Outcomes

A patient-reported outcome (PRO) is a measurement based on a report that comes from the patient (ie, study subject) about the status of their health condition without amendment or interpretation of the report by a clinician or anyone else. A PRO can be measured by self-report or interview, provided that the interviewer records only the patient’s response. Symptoms or other unobservable concepts known only to the patient (eg, pain severity or nausea) can only be measured by PRO measures. PROs can also assess the patient perspective on functioning or activities that may also be observable by others, such as quality of life, time to pain progression, and time to deterioration of physical symptoms.

In 2016, the American Society of Clinical Oncology (ASCO) reported the FDA indicated that benefits in PROs can be the basis for full drug approval (1). While this is true and PROs are clearly the best way to collect patient data in clinical trials, the American Medical Association points out that other challenges exist that many oncology studies struggle to overcome: small patient numbers, very sick or terminally ill patients, high failure rates, and single-arm studies unique to the development of new therapies in oncology (2). For this reason, careful thought must go into designing and implementing PRO measures in the oncology clinical trial setting (3).

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Katie Garner is Therapeutic Areas Advisor at CRF Health. She is responsible for providing specific therapeutic advice and supporting the therapeutic, sales, marketing and product development teams. Previously, Katie worked as a Project Manager for a Health Outcomes Consultancy and at the NHS Purchasing and Supply Agencies Centre for evidence-based purchasing. She also worked for the Medicine and Healthcare Products Regulatory Agency as a Senior Medical Device Specialist where she was responsible for the safety and regulation of in vitro diagnostic and contraceptive medical devices.
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Huge boom in Korean Pharma reported at CPhI Korea

Amsterdam, 19th September 2019: The recently-closed CPhI Korea – co-organised by Informa Markets and the Korea Pharmaceutical Traders Association (KPTA) – has seen a surge in growth across domestic and international pharma companies, as well as a sizable rise in overall attendees. As reported earlier this year in the provisional findings of the CPhI Pharma Index[1], Korea has seen a rapid growth in its international reputation (seeing its ‘overall competitiveness’ rise 14% in the last two years), which is now translating into a sizable growth in the market and at the event.
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Industry Events

Clinical Trial Supply New England

24-25 March 2020, Boston, US

Following on from another successful conference Arena International will be returning with full force to Waltham in March to celebrate another edition of the Clinical Trial Supply show. 2020 will gather the key stakeholders in the clinical trials community, including the FDA, US Customs and Border Protection, Biogen, Sanofi, and Blueprint Medicines Corporation. With interactive session formats, fresh content and networking, the event will provide attendees with an unparalleled opportunity for collaboration between players across the whole industry.
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