Introduction: Clinical Trial Registries
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Introduction: Clinical Trial Registries
Tracy J. Beck Coleader of the CTR Working Group Publication Team
Barbara 1. Gadlrw Coleader ofthe CTR Working Group Publication Team
A few years ago, as various stakeholders started expressing different and sometimes conflicting requirements for clinical trial transparency, a small group of people responsible for disclosing clinical trial information for biopharmaceutical companies decided that a forum would be beneficial for learning about and discussing these new requirements. Shortly thereafter, a Clinical Trial Registry (CTR) Working Group was formed within the DIA Good Clinical Practice/Quality Assurance (GCP/QA) Special Interest Area Community (SIAC). The group has continued to grow in membership and has monthly teleconferences. In addition to the monthly meetings, the CTR Working Group initially conducted a few webinars as a way to share knowledge. Three years ago, they conducted a 2-day conference in collaboration with a number of other SIACs. Since then, the working group has conducted an annual 2-day conference preceded by a halfday workshop. As part of the CTR Working Group mission is to share knowledge and educate others on the topics and issues related to clinical trial regis-
tration and results databases, a smaller subgroup of writers within the CTR Working Group decided to expand some of the conference presentations into journal articles. The articles that follow are the result of a year and a half of labor. Unfortunately, the challenge the authors face is that the clinical trial registry and results database environment changes so rapidly that it becomes difficult to keep articles current. As you read the following articles on clinical trial registry and results database history, global overview of legislation, databases versus manuscripts, industry surveys, patient advocacy perspectives, processes for companies and global trials, and unintended consequences, keep in mind that they are as current as possible given submission and review times. On behalf of the authors and the CTR Working Group, we hope you enjoy reading the articles as much as we enjoyed writing them. If you are interested in joining the DIA CTR Working Group, please contact Mary Hildebrandt ([email protected]). Membership is open to DIA members.
Tracy I. Beck has disclosed that she is an employee of Eli Lilly and Company. Barbara I. Godlew has disclosed that she has served as a consultant to Merck. Novartis, Astellas. Bayer, and Gilead: that she is a stock shareholder of Novartis: and that she has received an honorarium from Sylogent and Perspective Informatics.
dij.sagepub.com at UNIV OF CONNECTICUT on May 23, 2015 rug ~nformauon~ o ~ r Downloaded n avd. l , 44.from p. 2m. 2010 0092-~15/2010 Printed in the USA. All rights resewed. Copyright 0 2010 Drug Infonotion Association. Inc.
Submitted for Publication January 16,2010 Accepted for Publication:January 26,2010
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