Socioeconomic burden of participation in clinical trials in patients with myeloproliferative neoplasms

Swati Goel, Chiara Paoli, Alessandra Iurlo, Arturo Pereira, Fabio Efficace, Tiziano Barbui, Ayalew Tefferi, Alessandro M. Vannucchi, Francisco Cervantes

Research output: Contribution to journalArticle

1 Citation (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)36-41
Number of pages6
JournalEuropean Journal of Haematology
Volume99
Issue number1
DOIs
StatePublished - Jul 1 2017

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Clinical Trials
Neoplasms
Occupational Health Physicians
Social Participation
Essential Thrombocythemia
Costs and Cost Analysis
Polycythemia Vera
Primary Myelofibrosis
Hematologic Diseases
Social Change
Informed Consent
Psychological Stress
Spain
Italy
Cross-Sectional Studies
Therapeutics
Pharmaceutical Preparations

Keywords

  • Clinical trials
  • myeloproliferative neoplasms
  • socioeconomic burden

ASJC Scopus subject areas

  • Hematology

Cite this

Socioeconomic burden of participation in clinical trials in patients with myeloproliferative neoplasms. / Goel, Swati; Paoli, Chiara; Iurlo, Alessandra; Pereira, Arturo; Efficace, Fabio; Barbui, Tiziano; Tefferi, Ayalew; Vannucchi, Alessandro M.; Cervantes, Francisco.

In: European Journal of Haematology, Vol. 99, No. 1, 01.07.2017, p. 36-41.

Research output: Contribution to journalArticle

Goel, S, Paoli, C, Iurlo, A, Pereira, A, Efficace, F, Barbui, T, Tefferi, A, Vannucchi, AM & Cervantes, F 2017, 'Socioeconomic burden of participation in clinical trials in patients with myeloproliferative neoplasms', European Journal of Haematology, vol. 99, no. 1, pp. 36-41. https://doi.org/10.1111/ejh.12887
Goel, Swati ; Paoli, Chiara ; Iurlo, Alessandra ; Pereira, Arturo ; Efficace, Fabio ; Barbui, Tiziano ; Tefferi, Ayalew ; Vannucchi, Alessandro M. ; Cervantes, Francisco. / Socioeconomic burden of participation in clinical trials in patients with myeloproliferative neoplasms. In: European Journal of Haematology. 2017 ; Vol. 99, No. 1. pp. 36-41.
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