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See detailClinical trials of new drugs for the treatment of rheumatoid arthritis: focus on early disease
SMOLEN, J.S.; COLLAUD BASSET, S.; BOERS, M. et al

in Annals of Rheumatic Diseases (2016)

The European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases convened a task force of experts in rheumatoid arthritis (RA) and clinical trial ... [more ▼]

The European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases convened a task force of experts in rheumatoid arthritis (RA) and clinical trial methodology to comment on the new draft ‘Guideline on clinical investigation of medicinal products for the treatment of RA’ released by the European Medicines Agency (EMA). Special emphasis was placed by the group on the development of new drugs for the treatment of early RA. In the absence of a clear definition of early RA, it was suggested that clinical investigations in this condition were conducted in disease-modifying antirheumatic drugs naïve patients with no more than 1 year disease duration. The expert group recommended using an appropriate improvement in disease activity (American College of Rheumatology (ACR) or Simplified/Clinical Disease Activity Index (SDAI/CDAI) response criteria) or low disease activity (by any score) as primary endpoints, with ACR/European League Against Rheumatism remission as a secondary endpoint. Finally, as compelling evidence showed that the Disease Acrivity Score using 28-joint counts (DAS28) might not provide a reliable definition of remission, or sometimes even low disease activity, the group suggested replacing DAS28 as a measurement instrument to evaluate disease activity in RA clinical trials. Proposed alternatives included SDAI, CDAI and Boolean criteria. [less ▲]

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See detailRecommendations for the registration of drugs to treat sarcopenia
Reginster, Jean-Yves ULg; Cooper, C; Rizzoli, R et al

in Osteoporosis International (2015), 26(S1), 62

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See detailErratum to : Recommendations for the health economics analysis to be performed with a drug to be registered in prevention or treatment of osteoporosis
Dere, W; Avouac, B; Boers, M et al

in Calcified Tissue International (2013), 93

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See detailThe use of placebo-controlled and non-inferiority trials for the evaluation of new drugs in the treatment of postmenopausal osteoporosis
Delmas, P. D.; Calvo, Gisèle ULg; Boers, M. et al

in Osteoporosis International (2002), 13(1), 1-5

Registration of new agents for the treatment of postmenopausal osteoporosis has been based over the past few years on placebo-controlled phase III trials with the incidence of patients with new vertebral ... [more ▼]

Registration of new agents for the treatment of postmenopausal osteoporosis has been based over the past few years on placebo-controlled phase III trials with the incidence of patients with new vertebral/nonvertebral fractures as the most usual primary endpoint. The use of a placebo in diseases where an active treatment is available has been a matter of debate following the update of the Declaration of Helsinki by the World Medical Association which questioned this trial design. Current regulatory recommendations within the European Union suggest that placebo-controlled trials are still the best option when assessing the efficacy and safety of new drugs intended for the treatment of postmenopausal osteoporosis. This suggestion seems to be in apparent contradiction with the current content of the Declaration of Helsinki. This paper addresses the ethics and feasibility of placebo-controlled trials in the treatment of postmenopausal osteoporosis, in the light of available therapeutic options, and discusses possible alternative approaches in those patients where placebo treatment could be deemed to be unethical. It is concluded that placebo-controlled trials remain the most efficient design to establish the efficacy and safety of a new agent for the treatment of postmenopausal osteoporosis. Such trials are feasible and ethically acceptable in patients with osteoporosis but without prevalent vertebral fractures. Conversely, in patients with prevalent vertebral fractures, placebo-controlled trials are ethically questionable and non-inferiority trials are more appropriate. A relative margin of non inferiority of 20-30% is suggested, to be discussed on a case by case basis. [less ▲]

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See detailRecommandations for the registration of drugs used in the treatment of osteoarthritis : an update on biochemical markers
Vignon, E; Gamero, P; Delmas, P et al

in Osteoarthritis and Cartilage (2001), 9

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See detailRecommendations for the health economic analysis to be performed with a drug to be registered in prevention or treatment of osteoporosis
Dere, W; Avouac, B; Boers, M et al

in Calcified Tissue International (1998), 63

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