Position paper Towards a European Network for Multiple Sclerosis Trials (ENMST) L Kappos* ,1 , C Polman 2 , AJ Thompson 3 , P Duda 1 , M Clanet 4 , G Comi 5 , HP Hartung 6 and X Montalban 7 1 Outpatient Clinic Neurology-Neurosurgery, University Hospitals, Basel, Switzerland; 2 Department of Neurology, Free University VU Medical Centre, Amsterdam, the Netherlands; 3 Department of Neurology, The National Hospital, London, UK; 4 Department of Neurology, CHU Ho ˆpital Purpan, Toulouse, France; 5 Centro Sclerosi Multipla, Ospedale San Raffaele, Milan, Italy; 6 Department of Neurology, Heinrich-Heine-University, Du ¨ sseldorf, Germany; 7 Department of Neuroimmunology, University Hospitals, Vall d’Hebron, Spain Quality standards for clinical studies in the field of multiple sclerosis (MS) have improved significantly, to the great benefit of patients. This development has been accompanied by soaring costs and ever increasing complexity, with industry-independent trials having become virtually impossible. We propose establishing a European network that would include expertise in all the relevant aspects of MS treatment trials. In a stepwise approach, all interested active centres across Europe should be recruited into the network, based on agreement upon common scientific standards and quality requirements. Three main goals are discussed: . to facilitate identification of potentially useful agents for MS treatment; . to establish protocols for the interaction between investigators and industry; and . to identify common standards and a core set of data to allow for comparisons of MS trials. C ollaboration with existing international organizations and institutions, especially the Sylvia Lawry Centre for MS Research, as well as with similar initiatives in North America and other parts of the world is envisaged. Multiple Sclerosis (2003) 9, 627 ¡/629 Key words: clinical trials; methods; multiple sclerosis; quality standards Introduction Over the past decade, quality standards for clinical studies in health sciences in general, and in the field of multiple sclerosis (MS) in particular, have improved significantly, to the great benefit of patients. This process started due to increasing awareness of quality standards in the scientific medical community 1 and was boosted over the past decade by stringent requirements of regulatory authorities for approval of novel therapeutic agents. 2 This development towards better quality has been accompanied by soaring costs for clinical trials due to a large administrative overhead and ever increasing num- bers of patients, as well as health care professionals participating in any given clinical trial. An average multicentre international Phase III trial in MS nowadays will cost in excess of 10 million. Industry-independent trials have thus become virtually impossible, since no public or other private organization is usually prepared to spend such a large sum on one individual project. This has resulted in a number of issues that need to be addressed. There are now few studies that are indepen- dent of industry and consequently there is a need to explore ways in which investigators collaborate with industry. 3,4 A third issue, relating directly to inconsistent study design, is the lack of comparability of data between individual trials. These three issues identified in MS trials will now be discussed in more detail. Lack of industry-independent studies Trials have been and are set up to show statistical significance as early as possible for rapid submission to regulatory authorities. Often choices are more about extending the indications for an existing agent than exploring new and more relevant therapeutic strategies. 5 Questions that are deemed to be ‘only’ of scientific interest, or that may risk shedding an unfavourable light on the product concerned, are usually insufficiently addressed. Funding for long-term follow-up is sparse and often nonexistent despite the fact that these data are very relevant for clinical as well as socioeconomic reasons in determining whether an expensive MS treatment is only *Correspondence: Ludwig Kappos, MD, Outpatient Clinic Neurology-Neurosurgery, University Hospitals, Kantonsspital, Petersgraben 4, CH-4031 Basel, Switzerland. E-mail: lkappos@uhbs.ch Received 17 March 2003; revised 16 July 2003; accepted 17 July 2003 Multiple Sclerosis 2003; 9: 627 ¡ /629 www.multiplesclerosisjournal.com # Arnold 2003 10.1191/1352458503ms962xx at PENNSYLVANIA STATE UNIV on September 18, 2016 msj.sagepub.com Downloaded from