LONDON, May 24 /PRNewswire-FirstCall/ -- GlaxoSmithKline (GSK) reports today that it has now made available to the public detailed summaries of more than 2,600 clinical trials conducted in 50 countries to study 52 GSK prescription medicines and vaccines.
The information is found in the GSK Clinical Trial Register, a database accessible through the home page of the company’s Web site at http://www.gsk.com. Direct access to the Register is available at http://ctr.gsk.co.uk.
“We have created a record of transparency which we believe is unsurpassed in regard to medical interventions that affect the daily lives of patients,” said Frank Rockhold, Senior Vice President, Biomedical Data Sciences, GSK Research & Development.
“The initiative to make healthcare information more widely available is growing as more pharmaceutical companies create results databases. It will progress further if not only more companies but also academic and government sponsors create public databases of the results of their research into various medical interventions.”
In the current issue of The Lancet, Rockhold and Ronald Krall, Senior Vice President and Chief Medical Officer, GSK, note the growing potential of databases like the GSK Register and the possible need for medical journals to adjust policies that discourage publication of data initially appearing online.(1)
“We would urge medical journals to ensure that their prior-publication policies do not unduly restrict researchers who wish to put research results online in a timely fashion,” Rockhold said.
The GSK Register comprises clinical studies of all types (Phases I-IV) which have been sponsored by GSK anywhere in the world since December 27, 2000, the date when the corporate merger creating GSK took effect. The summaries are typically adapted for presentation in a format agreed by the International Conference on Harmonization (ICH), which represents industry and regulatory agencies in Europe, the United States, and Japan.
Concerning the GSK Register, GSK also reported the following other developments:
-- The number of visits to the GSK Register trended steadily upward through 2005 and early 2006, from 320 a day in the first quarter of 2005 to 920 a day in the first quarter of 2006. -- GSK has revised its standard contracts for co-development agreements so that in the future business partners will need to agree that trial summaries be posted to the GSK CTR under the current posting requirements.
(1) Rockhold FW, Krall RL. Trial summaries on results databases and journal publication. Lancet 2006; 367: 1636.
GlaxoSmithKline
CONTACT: Inquiries: UK Media inquiries: Philip Thomson, Alice Hunt, orGwenan Evans, (020) 8047 5502; US Media inquiries: Nancy Pekarek,+1-215-751-7709, or Mary Anne Rhyne, +1-919-483-2839, or Patricia Seif,+1-215-751-7709; European Analyst/Investor inquiries: Duncan Learmouth,(020) 8047 5540, or Anita Kidgell, (020) 8047 5542, or Jen Hill, (020) 80475543, or David Mawdsley (020) 8047 5564; US Analyst/Investor inquiries:Frank Murdolo, +1-215-751-7002, or Tom Curry, +1-215-751-5419, all ofGlaxoSmithKline
Web site: http://www.gsk.com/http://ctr.gsk.co.uk/
Company News On-Call: http://www.prnewswire.com/comp/801350.html/
