Mark,
I'm delighted to say that my company do pre-register their trials. When I work in 'academia' I regularly observed practices that I objected to. See for example: Currie CJ. Authorship. (Author saw fraud, misconduct, and unfairness to more junior staff.) British Medical Journal 1997;315:744-8, and Currie CJ. Regional clearing for biomedical manuscripts. Lancet 1998;351:1518. I have found none of these practices in industry, although I accept that some of the 'marketing' of industries science is better. At the ISTAHC conference, Edinburgh, one of the themes of the conference was to discuss how we can better change clinical practice as a consequence of improvements in clinical evidence. I would say that industry is merely better at achieving this, albeit because of the financial incentives involved.
Other areas of the biomedical science 'industry' could learn a great deal from the pharmaceutical industry not only in this sense, but in also eliminating fraud and misconduct.
Warm wishes, Craig
> Craig Currie Ph.D.
> Manager- GI & Metabolic Diseases
> Global Health Outcomes
> GlaxoWellcome
>
> -----Original Message-----
> From: Mark Fenton [SMTP:[log in to unmask]]
> Sent: Thursday, November 11, 1999 9:40 AM
> To: [log in to unmask]
> Subject: Re: Requiring preregistration of trials for licensing
>
> David Doggett wrote:
>
> > Subject: Requiring preregistration of trials for licensing
>
> > In the most recent JAMA there is
> > a scathing editorial by Drummond Rennie that was prompted by an article in
> > the same issue concerning the use of disguised multiple publications and
> > inappropriate controls in pharmaceutical trials to possibly gain licensing
> > and innappropriate commercial advantage.
>
> As part of a team doing a systematic review of olanzapine
> (another Eli Lilly drug), I have some sympathy with the
> multiple publication issue. One study, (Tollefson 1997), has
> so far hit 82 for the number of separate publications (which
> admittedly includes conferences). A little bit of fun was
> had trying to work out the number of people randomised to
> the number of study reports, this is what we found:
>
> "There is a close correlation between study size and number
> of presentations. If regression analysis of the data in
> Table 01 is undertaken on a log-graph the least-squares line
> makes a close fit (R2=0.92). For every 10 people randomised
> in an olanzapine versus typical drugs comparison there is a
> report. A study of 10 could be predicted to merit a report,
> of 100-10 presentations and of 1000-100 reports. Considering
> the likely under-identification of presentations of the
> larger studies this pattern of comprehensive dissemination
> does not seem too unlikely"
>
> > These problems were exacerbated
> > because the authors of the JAMA meta-analysis were unable to adequately deal
> > with the problems using the information in the pubished reports; and the
> > study authors, institutions and pharmaceutical companies that controlled the
> > original data were uncooperative. At best this is incompetent science on
> > the part of the study authors; and at worst it may be cynical manipulation
> > of data by the pharmaceutical companies. These sorts of things makes a
> > mockery of the licensing process and the published scienific record.
>
> I didn't fully understand the comments about the risperidone
> meta-analysis, as a Cochrane systematic review has been done
> and is published and maintained in the Cochrane Library, so
> is maybe not so much about incompetent science on the part
> of the study authors (shrewd marketing though). Certainly
> it becomes more difficult when there are multiple citations
> of one study, but it is manageable.
>
> Also, in fairness to the drug companies, more and more they
> are co-operating with groups like Cochrane, (Eli Lilly have>
> helped us enormously with identification of extra data and
> confirmed the citations that we found as being part of which
> study - admittedly they benefit if the review goes in their
> favour and we have to be wary of selective 'drip feeding' of
> information).
>
> I suppose the point I'm making is there are changes
> happening, where it becomes harder and harder for companies
> to 'hide' trials, but the sooner they start registering them
> at an independent site, it will become easier. There is a
> problem though, as many trials are done in non-english
> speaking places, and english speakers tend to ignore the
> non-english published journals.
>
> With every best wish,
>
>
> Mark Fenton
> Research Nurse
> Cochrane Schizophrenia Group
%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%
|