title: [Aim, content, evaluation and perspectives of surgical training in randomized trials at the Study Centre of the German Surgical Society].
abstract: BACKGROUND
  Clinical research, especially the management of randomized controlled multicentre trials, is a challenge for surgical investigators. To provide the theoretical background and practical knowledge needed for surgical trials, it is necessary to revise standard training programmes, which focus on pharmacological research. The main differences concern regulatory aspects and content, especially in achieving and maintaining comparability, equal treatment, and outcome assessment using special randomisation techniques and standardised surgical procedures.
  
  
  METHODS
  In November 2005, in cooperation with the Coordinating Centre for Clinical Trials in Heidelberg, the Study Centre of the German Surgical Society Study Group (SDGC) hosted a clinical investigation course for surgeons. During 3 days, 24 participants were systematically instructed by 16 lecturers on clinical trials (planning, treatment by protocol, data management, biometrics, ethics, and law), followed by participants' evaluation of the course.
  
  
  RESULTS
  On a scale of 1 to 6 (excellent to insufficient, respectively) the mean grades for the course were 1.6 for content, 1.55 for clarity, and 1.55 for learning effect. Partial repetition, lack of work in small groups, and not enough materials to take home were the major criticisms.
  
  
  CONCLUSIONS
  The evaluation emphasised the necessity and value of the course. Further courses with continued evaluation are necessary and can be based on the same underlying concept. However, the mere qualification of surgeons as clinical investigators without substantial additional improvements in structural problems and increased financial project support will not fundamentally improve clinical research in Germany.
authors.affiliation: Studienzentrum der Deutschen Gesellschaft für Chirurgie, Abteilung für Allgemein-, Visceral-, Unfallchirurgie und Poliklinik, Universitätsklinikum Heidelberg, Im Neuenheimer Feld 110, 69120 Heidelberg.
authors.forename: J
authors.initials: J
authors.lastname: Veit
authors.forename: H-P
authors.initials: HP
authors.lastname: Knaebel
authors.forename: A
authors.initials: A
authors.lastname: Franck
authors.forename: S P
authors.initials: SP
authors.lastname: Luntz
authors.forename: C M
authors.initials: CM
authors.lastname: Seiler
mesh_terms: D001291:Attitude of Health Personnel; D003479:Curriculum; D004502:Education, Medical, Continuing; D005858:Germany; D006801:Humans; D015397:Program Evaluation; D016032:Randomized Controlled Trials as Topic; D012106:Research / Q000193:education*; D012955:Societies, Medical; D013043:Specialties, Surgical / Q000193:education*