title: [Focus on academic multicenter trials: impact of the German drug law on hematological/oncological therapy optimization trials].
abstract: BACKGROUND
  The purpose of this study was to evaluate the effect of legal regulations for clinical trials on study centers participating in investigator-initiated trials (IITs) in the field of hematology/oncology.
  
  
  METHODS
  Questionnaires were sent out to the heads of hematology-oncology study centers.
  
  
  RESULTS
  Medical units participating in IITs have a good infrastructure and extensive experience in clinical trials. Depending on indication, a high proportion of patients have been treated in studies with the purpose to improve outcome. However, 35% of the responders will reduce their participation in IITs in the future due to a lack of financial support for staff involved in the extensive organizational tasks.
  
  
  CONCLUSIONS
  The widely recognized research field in therapy optimization trials in hematology and oncology in Germany is at risk. This will have negative effects on the patients as highly sophisticated protocols will no longer be initiated in several study centers, resulting in the loss of valuable data for the improvement of patient therapy and outcome. To stop this development, legislators as well as regulatory authorities and health insurances need to make the necessary changes in the legal framework.
authors.affiliation: Kompetenznetz Leukämien, Medizinische Klinik II, Hämatologie und Onkologie, Studienzentrale, Klinikum der Goethe-Universität, Frankfurt a.M., Deutschland.
authors.forename: Kristina
authors.initials: K
authors.lastname: Ihrig
authors.forename: Birgit
authors.initials: B
authors.lastname: Fath
authors.forename: Michael
authors.initials: M
authors.lastname: Fuchs
authors.forename: Michael
authors.initials: M
authors.lastname: Hallek
authors.forename: Norbert
authors.initials: N
authors.lastname: Marschner
authors.forename: Ralph
authors.initials: R
authors.lastname: Naumann
authors.forename: Christoph
authors.initials: C
authors.lastname: Röllig
authors.forename: Susanne
authors.initials: S
authors.lastname: Saussele
authors.forename: Hans
authors.initials: H
authors.lastname: Tesch
authors.forename: Nicola
authors.initials: N
authors.lastname: Gökbuget
mesh_terms: D000046:Academic Medical Centers / Q000331:legislation & jurisprudence* / Q000706:statistics & numerical data*; D000970:Antineoplastic Agents / Q000627:therapeutic use; D001291:Attitude of Health Personnel; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence* / Q000706:statistics & numerical data*; D005858:Germany; D006405:Hematology / Q000331:legislation & jurisprudence / Q000706:statistics & numerical data; D008495:Medical Oncology / Q000331:legislation & jurisprudence / Q000706:statistics & numerical data; D015337:Multicenter Studies as Topic / Q000331:legislation & jurisprudence / Q000706:statistics & numerical data*
chemical_list: D000970:Antineoplastic Agents