Nordic Myeloma Study Group, the first 15 years: scientific collaboration and improvement of patient care.
The accomplishments of the Nordic Myeloma Study Group (NMSG) during its first 15 yr are briefly surveyed, together with a discussion of principles guiding the group's clinical trials and of problems that need to be addressed in coming years. The group has so far carried out 12 clinical trials, comprising more than 2500 patients, spanning from minor phase II to large randomised phase III trials. At the time of writing, two randomised trials are running (comparing two doses of i.v. pamidronate, and melphalan-prednisone (MP) vs. MP-thalidomide to elderly patients). The group has strived for a simple organisation with much responsibility delegated to regional coordinators (Denmark 3, Norway 5, Sweden 5). With regard to trial design, the group has considered it important that studies are based on sound scientific questions, are simple to handle for the participants, population based, investigator initiated, include quality of life and health resources assessment as end-points, and can be used as basis for diverse scientific spin-off projects. Like other clinical trial groups, NMSG faces a number of challenges in coming years. The financial situation for independent investigator-initiated trials is far from satisfactory, especially with regard to the resource-consuming implementation of more stringent good clinical practice rules and ethical committee demands. NMSG has also encountered increasing difficulties in recruiting patients to recent trials, partly because of problems related to participating physicians (lack of support, laborious paper work, insufficient credit for participation). Solutions to these problems have to be found if industry-independent clinical trial groups are to survive.
Hippe
Erik
E
Department of Haematology L, University Hospital of Copenhagen, Herlev, Denmark.
Westin
Jan
J
Wislöff
Finn
F
D024221:Antineoplastic Protocols; D002986:Clinical Trials as Topic / Q000379:methods / Q000592:standards / Q000639:trends; D003299:Cooperative Behavior; D006801:Humans; D009101:Multiple Myeloma / Q000628:therapy*; D009664:Norway; D005791:Patient Care / Q000379:methods / Q000639:trends; D017410:Practice Guidelines as Topic