Abstract
Background: During recent years, the burden of bureaucracy in clinical research has increased dramatically, adversely
impacting the activity of investigators and clinical research teams. Although compliance with the Declaration of Helsinki,
the guidelines for Good Clinical Practice (GCP), and other applicable regulations remains unquestionable, their
overinterpretation and substitution by the internal operating procedures of sponsors and Contract Research
Organizations (CROs) have increased the administrative burden. A survey conducted by the European Society for
Medical Oncology (ESMO) Clinical Research Observatory (ECRO) among 940 investigators confirmed that they
considered that the administrative burden in clinical research is excessive; that administrative procedures could be
reduced without affecting the safety and the rights of the patients and the quality of the data; and that
bureaucracy represents an obstacle for clinical research.
Methods: A panel of physicians with extensive experience in clinical research, composed by members of the ECRO and
the ESMO Scientific Medical and Public Policy divisions, analyzed clinical trial procedures related to administrative
workflow, pharmacovigilance, and medical care.
Results: The panel identified situations that generate debate between investigators and sponsors/CROs and selected
real clinical scenarios that exemplify such situations. The panel discussed and proposed specific recommendations
for those situations, based on GCP.
Conclusions: This initiative aspires to streamline clinical research procedures and to become a platform for discussion
among all clinical trial stakeholders, with the aim of promoting the sustainability of clinical research and the care of
cancer patients
impacting the activity of investigators and clinical research teams. Although compliance with the Declaration of Helsinki,
the guidelines for Good Clinical Practice (GCP), and other applicable regulations remains unquestionable, their
overinterpretation and substitution by the internal operating procedures of sponsors and Contract Research
Organizations (CROs) have increased the administrative burden. A survey conducted by the European Society for
Medical Oncology (ESMO) Clinical Research Observatory (ECRO) among 940 investigators confirmed that they
considered that the administrative burden in clinical research is excessive; that administrative procedures could be
reduced without affecting the safety and the rights of the patients and the quality of the data; and that
bureaucracy represents an obstacle for clinical research.
Methods: A panel of physicians with extensive experience in clinical research, composed by members of the ECRO and
the ESMO Scientific Medical and Public Policy divisions, analyzed clinical trial procedures related to administrative
workflow, pharmacovigilance, and medical care.
Results: The panel identified situations that generate debate between investigators and sponsors/CROs and selected
real clinical scenarios that exemplify such situations. The panel discussed and proposed specific recommendations
for those situations, based on GCP.
Conclusions: This initiative aspires to streamline clinical research procedures and to become a platform for discussion
among all clinical trial stakeholders, with the aim of promoting the sustainability of clinical research and the care of
cancer patients
| Original language | English |
|---|---|
| Pages (from-to) | 70-77 |
| Number of pages | 8 |
| Journal | Annals of Oncology |
| Volume | 34 |
| Issue number | 1 |
| Early online date | 6 Oct 2022 |
| DOIs | |
| Publication status | Published - Jan 2023 |
Bibliographical note
Funding Information:The panel acknowledges the work of Klizia Marinoni and Delanie Young, from the Scientific and Medical Division at ESMO, for coordinating the project and for editorial assistance, and Paul Miller, PhD, from University of Navarra, for English language editing.
Publisher Copyright:
© 2022 European Society for Medical Oncology
