GlaxoSmithKline to set up comprehensive online clinical trials registerBMJ 2004; 329 doi: https://doi.org/10.1136/bmj.329.7466.590-d (Published 09 September 2004) Cite this as: BMJ 2004;329:590
GlaxoSmithKline (GSK) has set up the first comprehensive register of pharmaceutical trials in the industry, two weeks after settling for $2.5m (£1.41m; €2.07m) a US lawsuit that accused the London based company of burying unfavourable results.
The lawsuit, launched by New York State's attorney general Eliot Spitzer, accused GSK of “repeated and persistent fraud,” alleging that the company suppressed data from at least four trials of the antidepressant paroxetine (marketed as Seroxat in Britain and as Paxil in the United States) (12 June, p 1395). The trials, which studied the drugs in adolescents, either showed no benefit over placebo or a slight increase in self harming behaviour.
On 25 August, GSK settled the lawsuit, saying in a statement that although it believed the allegations were “unfounded,” it had paid $2.5m to the State of New York to avoid the expense of a protracted legal battle.
The drug manufacturer also agreed to publish on its website “summaries” of all of its trials since 27 December 2000, when Glaxo Wellcome merged with SmithKline Beecham. The first summaries, posted a week after the settlement, described 65 tests of the diabetes drug rosiglitazone (Avandia).
GSK said that all the promised summaries should be posted by the end of 2005. In addition, the company said it would post summaries of selected trials that finished before 2000, “if they are likely to inform medical judgment.”
In the case of new drugs, GSK “intends to post summaries no later than the first launch of a medicine or new formulation in a major market,” although the terms of the settlement actually permit a grace period of 10 months after a new drug first reaches market.
The summaries will be presented in a standardised format, including study design and population, statistical methods, confidence intervals, and adverse events. The company's register of clinical trials (http://ctr.gsk.co.uk) is free to access without registration.
Mr Spitzer said, “This settlement holds GSK to a new standard of disclosure about studies concerning its drugs, a standard that helps to ensure that doctors and patients have access to all scientifically sound information so doctors can prescribe appropriate medication for their patients.” He told reporters that the settlement was “what we were looking for,” and expressed his hope that other companies would follow suit.
Eli Lilly announced on 3 August that it will set up a comprehensive online register of trials this Autumn. Mr Spitzer's office has also contacted Johnson & Johnson and Forest Laboratories about unreleased trial data, although no subpoenas have been issued.
GSK's spokeswoman, Nancy Pekarek, said the company had already been working on a register of clinical trials before the lawsuit was filed, and the settlement merely attached deadlines to existing company policy.
The company warned that in some cases posting full summaries would be delayed while it seeks intellectual property protection, or while articles on company research are awaiting publication in medical journals. GSK is having discussions with two unnamed medical journals, seeking reassurances that its researchers' prospects of journal publication will not be harmed by pre-releasing data on the online register.