Drug Information Journal - March 2009 - (Page 195) CLINICAL TRIALS 195 Clinical Trial Registries: A Survey of Patient Advocate Group Perceptions There has long been a recognized need to provide the public in general, and specifically patients and physicians, with quality information about clinical trials—what diseases are being investigated, with what products, in what countries, and so on—and also to ensure that trial results are made publicly available. In 2005 Roche launched its own clinical trial protocol registry and results database designed to ensure transparency within its clinical trial activities and the disclosure of results. In early 2007 the company conducted a survey of patient advocate groups to ask for feedback on the Roche site and other nonbranded sites (eg, CenterWatch, IFPMA portal). The results indicate that the Roche site was well received, providing easy-to-use, transparent, and nonpromotional material. The patient groups also made recommendations for how to improve the content and services offered on the site and also on how to raise awareness among patients and patient groups about the availability of this information. Jacqueline Sayers, MBA, PhD Quality Projects Manager, Pharma Development Quality, Roche Products Ltd, Welwyn Garden City, Herts, UK Key Words Registry; Patient advocate group; Survey Correspondence Address Dr. Jacqueline Sayers, Quality Projects Manager, Pharma Development Quality, Roche Products Ltd., Hexagon Place, 6 Falcon Way, Shire Park, Welwyn Garden City, Herts, UK (email: jacqueline.sayers@ roche.com). INTRODUCTION GOALS OF CLINICAL TRIAL DISCLOSURE There has long been a recognized need to provide the public in general and specifically patients and physicians with quality information about clinical trials—what diseases are being investigated, with what products, in what countries, and so on, and also to ensure that trial results are made publicly available. There has been a steady increase in the number of clinical trial registries, and many countries and even some US states have guidelines or regulations in place or proposed that require sponsors to post details of protocols in some form of registry. There are, however, far fewer requirements related to the posting of trial results. The available registries often have different content requirements, making it increasingly hard to meet the needs of the various stakeholder groups—be they patients, physicians, regulators, journal editors, and so on. This increase in the number of registries, their varying requirements, and the challenges related to the registration of clinical trials have been discussed in several previous publications (eg, 1–3), and are not reviewed again here. It is possible however, to suggest some general requirements for a good registry or results database. WHAT MAKES A GOOD REGISTRY OR RESULTS DATABASE? • Accessible: Any computerized registry has the inherent problem that only those people with access to a computer and the Internet can get access. However, accepting this constraint, clearly any registry needs to be accessible free of charge. Individual patients should not be excluded from the information simply because they do not have adequate income. • Searchable: The data should be searchable, at least by location, disease area, and treatment option. It should also be simple to navigate through the site without having to download a user manual. • Contacts: The site should include a simple mechanism for viewers to get further information about the trial they are interested in. • Validity: Some sort of quality control should be applied to the data on the site so that the people viewing it have confidence that it is accurate and up to date. • Links: If the target customer’s needs are seen as the priority, then having links to other sites that may be of interest, including other registries, may be an advantage. • Glossary and disease information: A good glossary can aid understanding and transparency of the information presented on the site—particularly for patients who may not be so familiar with clinical trial jargon. Specific content about disease areas and treatments can also help to produce a more rounded registry site. Submitted for Publication: January 23, 2008 Accepted for Publication: May 30, 2008 Drug Information Journal, Vol. 43, pp. 195–200, 2009 • 0092-8615/2009 Printed in the USA. All rights reserved. Copyright © 2009 Drug Information Association, Inc.
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