title: Socioeconomic burden of participation in clinical trials in patients with myeloproliferative neoplasms.
abstract: OBJECTIVE
  To determine the financial and psycho-social impact of participation in clinical trials of patients with BCR/ABL-negative myeloproliferative neoplasms (MPN).
  
  
  METHODS
  An international, observational cross-sectional study was performed in 143 consecutive MPN patients (51% myelofibrosis, 36% polycythemia vera, 13% essential thrombocythemia), 68% from Italy, 17% from USA, and 15% from Spain.
  
  
  RESULTS
  Thirty-five percent of patients reported having spent more money during the trial than in previous treatments and 21% having missed more workdays. Twelve percent replied that they would not have participated in the trial if the financial consequences would have been known beforehand. In 10% of the patients, the interpersonal relationships were more affected during the trial than in previous treatment but, overall, 91% subjects believed that participating in the clinical trial was worth the financial or emotional suffering. Concerning patients' suggestions, 54% of them indicated that the number of visits required for the trial should be clearly specified in the informed consent, 60% recommended travel cost reimbursement, and 23% hotel cost reimbursement.
  
  
  CONCLUSIONS
  Physicians and pharmaceutical companies involved in clinical trials with patients with hematological diseases should be aware of these problems and make efforts to attenuate the socioeconomic burden of participation in the trials.
authors.affiliation: Department of Hematology and Oncology, Montefiore Medical Center, Bronx, NY, USA.
authors.forename: Swati
authors.initials: S
authors.lastname: Goel
authors.affiliation: Center of Research and Innovation of Myeloproliferative Neoplasms, AOU Careggi, University of Florence, Florence, Italy.
authors.forename: Chiara
authors.initials: C
authors.lastname: Paoli
authors.affiliation: Oncohematology Division, IRCCS Ca' Granda-Maggiore Policlinico Hospital Foundation, Milan, Italy.
authors.forename: Alessandra
authors.initials: A
authors.lastname: Iurlo
authors.affiliation: Hemostasis Department, Hospital Clínic, Barcelona, Spain.
authors.forename: Arturo
authors.initials: A
authors.lastname: Pereira
authors.affiliation: GIMEMA Data Center and Health Outcomes Research Unit, Rome, Italy.
authors.forename: Fabio
authors.initials: F
authors.lastname: Efficace
authors.affiliation: Research Foundation, Ospedale Papa Giovanni XXII, Bergamo, Italy.
authors.forename: Tiziano
authors.initials: T
authors.lastname: Barbui
authors.affiliation: Division of Hematology, Department of Medicine,  Mayo Clinic, Rochester, MN, USA.
authors.forename: Ayalew
authors.initials: A
authors.lastname: Tefferi
authors.affiliation: Center of Research and Innovation of Myeloproliferative Neoplasms, AOU Careggi, University of Florence, Florence, Italy.
authors.forename: Alessandro M
authors.initials: AM
authors.lastname: Vannucchi
authors.affiliation: Hospital Clínic, IDIBAPS, University of Barcelona, Barcelona, Spain.
authors.forename: Francisco
authors.identifier: http://orcid.org/0000-0003-2664-8131
authors.initials: F
authors.lastname: Cervantes
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002986:Clinical Trials as Topic; D017281:Cost of Illness; D003430:Cross-Sectional Studies; D005260:Female; D006801:Humans; D007558:Italy / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D009196:Myeloproliferative Disorders / Q000175:diagnosis / Q000453:epidemiology* / Q000628:therapy; D012959:Socioeconomic Factors; D013030:Spain / Q000453:epidemiology; D014481:United States / Q000453:epidemiology; D055815:Young Adult
keywords: Clinical trials; myeloproliferative neoplasms; socioeconomic burden