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Perspectives of the Working Group on Drug Trials including Collaborative Trials of the ISBD and rationale for new clinical trials

The goals of the working group are to contact and recruit members; to contact other working groups and propagate their work particularly in the context of established criteria of diagnosis and disease activity in Behçet's disease (BD); to exchange experience via direct contact, home page, journal and/or newsletter; to plan collaborative trials; to contact pharmaceutical companies and research institutes for possible cooperation in clinical trials; to prepare a workshop on clinical trials at ISBD congresses; and to support and alert patients concerning treatment modalities.

Additional clinical trials are needed. From both the physicians' and the patients' perspective, current therapy does not satisfy the goals of treatment (e.g. preventing blindness in ocular BD, preventing morbidity and mortality of neurologic and vascular events, improving the quality of life). Serious adverse effects may result from current therapies. Professor S Assaad-Khalil reported the results of a retrospective evaluation of therapeutic agents commonly used in BD, which he had recently carried out in 127 patients (110 males, 17 females; 20–65 years old) randomly selected from the Alexandria BD registry to assess the efficacy of different therapeutic agents in daily practice for a mean duration of 11.07 years by the same group of observers. A special focus was made on the ocular sequelae of the disease, with detailed ocular documentation carried out in 254 eyes (visual acuity, intraocular pressure, state of the lens, presence of uveitis, retinal vessels and optic nerve). Of BD patients 16.6% lost effective vision and another 17.6% of the patients had reduced vision lower than 6/60. Uveitis was found in 37.4%, lens opacity in 44.9%, retinal vessel affection occurred in 23.3% and optic nerve affection in 29.9%. In conclusion, it can be seen that eye sequelae are still very devastating in BD, with a delay in diagnosis having a significant deleterious effect on the outcome of the disease. There is still no ideal therapeutic regimen resulting in full remission of BD and preventing its sequelae. At present, combination therapy seems to be the most appropriate approach when considering efficacy and safety. However, there is a great need for a controlled and masked multicentre trial to re-evaluate the efficacy and safety of the different therapeutic modalities on a long term basis.

Investigators must continue to have strong ethical commitments to patients in designing clinical trials. Trials serving patients, patients' life, health and well-being is our goal. There should be actual representation of the patients in the design of the clinical trials. A prospective study design, predetermined specific primary endpoints and blinding should ensure the integrity of the study. Improvement should be quantified as objectively and accurately as possible, putting into consideration patient's quality of life, and measuring all adverse effects. Statistics should depend on strict criteria for statistical significance, avoiding post hoc analysis.

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Assaad-Khalil, S. Perspectives of the Working Group on Drug Trials including Collaborative Trials of the ISBD and rationale for new clinical trials. Arthritis Res Ther 5 (Suppl 2), 2 (2003).

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