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Comparators, study duration, outcome measures and sponsorship in therapeutic trials of psoriasis: update of the EDEN Psoriasis Survey 2001-2006

Naldi, L.; Svensson, Åke LU ; Zenoni, D.; Diepgen, T.; Elsner, P.; Grob, J. -J.; Coenraads, P. -J.; Bavinck, J. N. Bouwes; Maccagni, A. and Linder, D., et al. (2010) In British Journal of Dermatology 162(2). p.384-389
Abstract
Background Several new therapeutic options for psoriasis have been tested in clinical trials in recent years. Choice of comparator, study duration and outcome measures are critical for interpreting application of trial results to clinical practice. Objectives We examined whether these trial aspects have changed substantially in recent years in comparison with the past. Methods A systematic search and evaluation of all randomized controlled trials (RCTs) for psoriasis published from January 2001 up to December 2006 in 14 leading medical and dermatological journals, compared with those published from 1977 to 2000. Results There were 140 RCTs of psoriasis in the period 2001-2006 and 249 in the period 1977-2000. The proportion of... (More)
Background Several new therapeutic options for psoriasis have been tested in clinical trials in recent years. Choice of comparator, study duration and outcome measures are critical for interpreting application of trial results to clinical practice. Objectives We examined whether these trial aspects have changed substantially in recent years in comparison with the past. Methods A systematic search and evaluation of all randomized controlled trials (RCTs) for psoriasis published from January 2001 up to December 2006 in 14 leading medical and dermatological journals, compared with those published from 1977 to 2000. Results There were 140 RCTs of psoriasis in the period 2001-2006 and 249 in the period 1977-2000. The proportion of placebo-controlled studies increased from 44.6% to 69.3%. The median study duration increased from 7 weeks to 12 weeks. The proportion of studies adopting the Psoriasis Area and Severity Index score as an outcome increased from 30.6% to 57.7%, while the number of studies incorporating a quality of life measure increased from only one (0.4%) to 12 studies (7.7%). The proportion of studies sponsored by pharmaceutical companies increased from 61.0% to 73.7%. Conclusions Despite the increased number of new options, the number of head-to-head comparative trials has decreased and most trials focus on short-term effects, probably reflecting the increased influence of industrial sponsorship on the research agenda. (Less)
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type
Contribution to journal
publication status
published
subject
keywords
survey, Psoriasis, randomized trial, treatment
in
British Journal of Dermatology
volume
162
issue
2
pages
384 - 389
publisher
Wiley-Blackwell
external identifiers
  • wos:000273633300023
  • scopus:74349123584
ISSN
1365-2133
DOI
10.1111/j.1365-2133.2009.09515.x
language
English
LU publication?
yes
id
a13d778d-16cd-41a9-a403-1e96e70695ca (old id 1547617)
date added to LUP
2010-02-23 13:30:05
date last changed
2018-05-29 10:41:27
@article{a13d778d-16cd-41a9-a403-1e96e70695ca,
  abstract     = {Background Several new therapeutic options for psoriasis have been tested in clinical trials in recent years. Choice of comparator, study duration and outcome measures are critical for interpreting application of trial results to clinical practice. Objectives We examined whether these trial aspects have changed substantially in recent years in comparison with the past. Methods A systematic search and evaluation of all randomized controlled trials (RCTs) for psoriasis published from January 2001 up to December 2006 in 14 leading medical and dermatological journals, compared with those published from 1977 to 2000. Results There were 140 RCTs of psoriasis in the period 2001-2006 and 249 in the period 1977-2000. The proportion of placebo-controlled studies increased from 44.6% to 69.3%. The median study duration increased from 7 weeks to 12 weeks. The proportion of studies adopting the Psoriasis Area and Severity Index score as an outcome increased from 30.6% to 57.7%, while the number of studies incorporating a quality of life measure increased from only one (0.4%) to 12 studies (7.7%). The proportion of studies sponsored by pharmaceutical companies increased from 61.0% to 73.7%. Conclusions Despite the increased number of new options, the number of head-to-head comparative trials has decreased and most trials focus on short-term effects, probably reflecting the increased influence of industrial sponsorship on the research agenda.},
  author       = {Naldi, L. and Svensson, Åke and Zenoni, D. and Diepgen, T. and Elsner, P. and Grob, J. -J. and Coenraads, P. -J. and Bavinck, J. N. Bouwes and Maccagni, A. and Linder, D. and Williams, H.},
  issn         = {1365-2133},
  keyword      = {survey,Psoriasis,randomized trial,treatment},
  language     = {eng},
  number       = {2},
  pages        = {384--389},
  publisher    = {Wiley-Blackwell},
  series       = {British Journal of Dermatology},
  title        = {Comparators, study duration, outcome measures and sponsorship in therapeutic trials of psoriasis: update of the EDEN Psoriasis Survey 2001-2006},
  url          = {http://dx.doi.org/10.1111/j.1365-2133.2009.09515.x},
  volume       = {162},
  year         = {2010},
}