Clinical Trial Registries: An Industry Perspective
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Clinical Trial Registries: An Industry Perspective
Lio McLean, BSc, PhD Principal Consultant, Pope Woodhead and Associates Ltd. St. Ives, LJK
Key Words Clinical trial registry; Pharmaceutical survey: Transparency Correspondence Address Dr. Lia McLean. Practice Head, Process Design and Implementation, Pope Woodhead and Associates Ltd. The Old Grammar School, I Ramsey Road, St. lves PE27 582,UK (email: lia.mclean Opopewoodhead. corn). A summary of the results in this survey was presented at the CBI Third Annual Premier Forum on clinical trial registries and results databases at the Sheraton Premier at Tyson's Comer, Vienna, Virginia, April 28-29.2008.
In recentyears an explosion has occurred in the disclosure of clinical trial infonnation through clinical trial registries, partly driven by legislative demands and the requirement by a group of pharmaceutical journals for increased tmnsparency As a consequence, a large amount of information is now availableto thegeneralpublic and health care providers. In complying with the disclosure rcqu'rements, d i f m t pharmaceutical companies have chosen different approaches in providing clinical trial infonnation. We conducted a survey among a sample of pharmaceutical companies of varying size to determine their views on the current situation, the challenges they face, and the fiture of the dinical trial disclosureinitiative. Key leanings were that, in their view, tmnsparency has improved substantialb but more so
INTRODUCTION Trust in the pharmaceutical industry is at an alltime low. A recent survey published by the Price Waterhouse Coopers (PwC) Research Institute describes this as a serious problem facing the pharmaceutical industry (1). Consumers and physicians believe that financial success and subsequent pressures have blurred the industry's greater purpose of improving human health. As part of its assessment, PwC recommends that a key area for improvement should be greater transparency, particularly in the areas of clinical development, around the risks and benefits of medicines, and their value for money. PwC also found that awareness is very low among the general public regarding the particular challenges, high costs, and regulatory constraints that accompany drug development (1).If allowed to go unchecked, a continuation of this crisis will adversely affect the long-term future and sustainability of the industry. One area where the industry has taken steps in recent years to improve transparency, prompted by demands from key journals and legislation, is clinical trial disclosure (CTD).
for the scientific community than for the patient. Patient awareness is thought to be rela-
tively low. h e increasing demands of legislation cause challenges for companies both in interpretation and in resource requirements, and it was thought this may cause the industry and the whde initiatbe to lose sight of the original aim, which was to imprcrve tmnsparencyfor the general public and the patient. Particular challenges mentioned indude the new requirements for dinical trial
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