Clinical Trial Registries: A Survey of Patient Advocate Group Perceptions
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Clinical Trial Registries: A Survey of Patient Advocate Group Perceptions
Jacqrelire Sayers, MBA, PhD Quality Projects Manager. Pharma Development Quality, Roche Products Ltd. Welwyn Garden City, Herts, UK
Key Words Registry; Patient advocate group; Survey Corrrsporderce 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. corn).
There has long been a recognized need to provide the public in general, and specificallypatients 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 2OQ5 Roche launched its own clinical tial protocd registry and results database designed to ensure transparency within its clinical tial activities and the disclosure of results. In early
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.
2007 the company conducted a survey of patient advocate groups to askfor feedback on the Roche site and other nonbrandedsites (eg, Cen&Watch, IEPMA portal). The results indicate that the Roche site was well received, providing easy-to-use, tmnsparent, and nonpromotional material. The patient groups also made recommendations for how to improve the content and services offeredon the site and also on how to raise awareness among patients and patient groups about the availability of this information.
WHAT MAKES A GOOD REGInRY OR RESULlS 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 patient
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