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International Clinical Trials

On the Register

 

Understanding the nuances of setting up an effective global registry is becoming increasingly important, since this kind of study enables manufacturers to gather and analyse data about the actual use of their products in every country where a product is marketed, while meeting stringent new regulatory requirements.

Key regulatory bodies in the EU and the US have passed legislation that has resulted in more regulations and greater governance, intensifying the pharmaceutical industry’s emphasis on drug safety (1,2). The requirements include greater focus on post-approval studies to address risk assessment and risk minimisation.

Registries – databases used to collect patient information for specific purposes – are among the types of studies used more and more to address these safety issues. Registries are often long-term in nature, therefore it is critical to consider a number of design factors, such as ensuring that objectives are well-defined with a justifiable purpose, calculating an appropriate sample size with representative patients registered, and creating clear, comprehensive plans for follow-up and patient retention. The protocol and operational plans should map out how best to facilitate communications with – and data collection from – patients and physicians.

VALUE AND FUNCTION OF REGISTRIES

In post-approval studies – such as registries, observational studies, surveillance programmes and large streamlined studies – data are gathered under real-world conditions, using larger, more heterogeneous populations than in controlled, randomised clinical trials (RCTs). With strict enrolment criteria, RCTs exclude subjects based on such demographic factors as age, gender and ethnicity, as well as health issues, such as co-medication and co-morbidity.


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Kim Maguire is Clinical Program Director at United BioSource Corporation, where she oversees the direction and design of late stage programmes. With over 17 years of experience in clinical research, Kim has extensive knowledge of a variety of therapeutic areas in both Phase IIIb and IV programmes and risk management programmes. She has been responsible for designing and delivering several programmes which have been designed to meet FDA and EMEA mandates for post approval regulatory commitments for risk assessment and risk minimisation, including performance-linked access systems, pregnancy exposure registries, and drug registries being conducted to support components of product REMS. She earned a BSc in Biology from Fairfield University and completed graduate coursework in microbiology at the University of Arizona.

Bruce Smith is Executive Director, Clinical Operations at United BioSource Corporation, where he is responsible for supervising the project management, medical monitoring, safety surveillance, site monitoring and site management groups in multiple UBC locations. Bruce’s primary focus is on large simplified trials, post-approval surveillance programmes (particularly regulatory agency required programmes), treatment INDs and well-controlled peri- and post-approval programmes. With 27 years of clinical, research and management experience, including involvement with 50 of the top 200 prescribed drugs in the US, Bruce has authored or co-authored over 100 journal articles on infectious disease. He earned his Doctor of Pharmacy at the Philadelphia College of Pharmacy and Science.

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Kim Maguire
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Bruce Smith
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