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Healthy Skepticism Library item: 19233

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

Publication type: Journal Article

Chan A
Access to clinical trial data
BMJ 2011 Jan 12; 342:
http://www.bmj.com/content/342/bmj.d80.extract


Abstract:

The high frequency and negative impact of selective reporting of data from clinical trials are well documented. 1 The widespread occurrence of data suppression means that healthcare practitioners and policy makers largely make decisions on the basis of an incomplete and biased subset of trial results. Selective reporting can often be identified by reviewing trial protocols and publications; it can be mitigated by defining standard core outcome sets for trials, and by ensuring access to all unpublished and published data ⇓ . 2 3

However, two linked articles highlight major difficulties in obtaining access to protocols and unpublished data for both industry and non-industry trials and provide new insight into trialists’ reasons for suppressing data. 4 5 These types of challenges have been described before, 6 7 and they reinforce the core principle that full knowledge of both the methods and results for all trials, independent of publication status, is essential for a complete and unbiased evaluation of an intervention.

Sources of information that should be consulted when appraising an intervention include trial protocols, registry records, regulatory agency documents, trial datasets, and journal publications. Smyth and colleagues (doi: 10.1136/bmj.c7153 ) also show …

 

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...to influence multinational corporations effectively, the efforts of governments will have to be complemented by others, notably the many voluntary organisations that have shown they can effectively represent society’s public-health interests…
A small group known as Healthy Skepticism; formerly the Medical Lobby for Appropriate Marketing) has consistently and insistently drawn the attention of producers to promotional malpractice, calling for (and often securing) correction. These organisations [Healthy Skepticism, Médecins Sans Frontières and Health Action International] are small, but they are capable; they bear malice towards no one, and they are inscrutably honest. If industry is indeed persuaded to face up to its social responsibilities in the coming years it may well be because of these associations and others like them.
- Dukes MN. Accountability of the pharmaceutical industry. Lancet. 2002 Nov 23; 360(9346)1682-4.