Pressures are growing to publish clinical trials
http://www.100md.com
《英国医生杂志》
EDITOR—After the threat of a court case in New York, GlaxoSmithKline has announced that it will publish results of all its clinical trials on its website.1 2 Eli Lilly recently made a similar announcement, including a commitment to publish all findings in peer reviewed journals.3
This will be welcome news to people such as Abrams and me, who have been (independently) campaigning for this for some time.4 Last year, following several years of consultation, a group from within the pharmaceutical industry published guidelines on good publication practice for pharmaceutical companies.5 One of the main recommendations was for companies to endeavour to publish the results of all clinical trials relating to their marketed products in peer reviewed journals.
We were careful to include the word "endeavour," since, ultimately, journal editors decide what gets published. However, with the growth of electronic journals we believe it is usually possible to publish trials. We also focused on clinical trials (those involving patients, rather than preclinical, laboratory experiments) and on marketed products, since we believed that these have the greatest impact on patients and prescribers. Of course, we encourage companies to publish all their research but suggest that priority should be given to clinical trials of marketed products.
A few companies have publicly endorsed the guidelines on good publication practice, and we hope that others may follow. The BMJ has shown its support by including a link to the website from its instructions to authors. The moves by GlaxoSmithKline and Eli Lilly show that companies notice that the environment is changing, and I urge doctors, patients' groups, and anybody with an interest in ethical drug research and drug safety to encourage other companies to commit to publishing all their trial results.
Elizabeth Wager, publications consultant
Sideview, Princes Risborough, Buckinghamshire HP27 9DE liz@sideview.demon.co.uk
Competing interests: EW is one of the authors of the guidelines on good publication practice for pharmaceutical companies and runs courses on publication ethics.
References
GlaxoSmithKline. GlaxoSmithKline settles litigation with New York Attorney General's Office. Press release, 26 August 2004. www.gsk.com/press-archive/press2004/press_08262004.pdf (accessed 31 Aug 2004).
Office of Attorney General, New York. Settlement sets new standard for release of drug information. www.oag.state.ny.us/press/2004/aug/aug26a_04.html (accessed 31 Aug 2004).
In brief. Drug company to make its trial results public. BMJ 2004;329: 366. (21 August.)
Abrams P. Access to every trial dataset is crucial. BMJ 2004;329: 462-b. (21 August.)
Wager E, Field EA, Grossman L. Good publication practice for pharmaceutical companies. Curr Med Res Op 2003;19: 149-54.
This will be welcome news to people such as Abrams and me, who have been (independently) campaigning for this for some time.4 Last year, following several years of consultation, a group from within the pharmaceutical industry published guidelines on good publication practice for pharmaceutical companies.5 One of the main recommendations was for companies to endeavour to publish the results of all clinical trials relating to their marketed products in peer reviewed journals.
We were careful to include the word "endeavour," since, ultimately, journal editors decide what gets published. However, with the growth of electronic journals we believe it is usually possible to publish trials. We also focused on clinical trials (those involving patients, rather than preclinical, laboratory experiments) and on marketed products, since we believed that these have the greatest impact on patients and prescribers. Of course, we encourage companies to publish all their research but suggest that priority should be given to clinical trials of marketed products.
A few companies have publicly endorsed the guidelines on good publication practice, and we hope that others may follow. The BMJ has shown its support by including a link to the website from its instructions to authors. The moves by GlaxoSmithKline and Eli Lilly show that companies notice that the environment is changing, and I urge doctors, patients' groups, and anybody with an interest in ethical drug research and drug safety to encourage other companies to commit to publishing all their trial results.
Elizabeth Wager, publications consultant
Sideview, Princes Risborough, Buckinghamshire HP27 9DE liz@sideview.demon.co.uk
Competing interests: EW is one of the authors of the guidelines on good publication practice for pharmaceutical companies and runs courses on publication ethics.
References
GlaxoSmithKline. GlaxoSmithKline settles litigation with New York Attorney General's Office. Press release, 26 August 2004. www.gsk.com/press-archive/press2004/press_08262004.pdf (accessed 31 Aug 2004).
Office of Attorney General, New York. Settlement sets new standard for release of drug information. www.oag.state.ny.us/press/2004/aug/aug26a_04.html (accessed 31 Aug 2004).
In brief. Drug company to make its trial results public. BMJ 2004;329: 366. (21 August.)
Abrams P. Access to every trial dataset is crucial. BMJ 2004;329: 462-b. (21 August.)
Wager E, Field EA, Grossman L. Good publication practice for pharmaceutical companies. Curr Med Res Op 2003;19: 149-54.