The administrative burden associated with clinical research has increased dramatically in the last years.
The ESMO Clinical Research Observatory was created in 2019 to analyze and provide the views of ESMO about this and other challenges faced by clinical research, based on the feedback from clinical investigators and under complete adherence to the applicable legal regulations.
Main objectives and methods
- Rationalization of the bureaucratic burden associated with clinical research, based on strict adherence to GCP guidelines and applicable regulations, and on showing respect to the time and expertise of clinical investigators and research teams.
- Avoid the clinical interference of protocols with best medical practice: protocols should avoid dictating strict and non-personalized instructions to manage clinically complex situations, which should generally be managed by the responsible physician according to best medical practice.
- Foster the generation of data on clinical research procedures.
- Issue general recommendations regarding relevant topics related to clinical research.
- Collaborate with other National and International Associations related to clinical research in order to endorse, revise and improve this initiative.
- Jose Luis Perez-Gracia
- Teresa Amaral
- Tobias Arkenau
- Ahmad Awada
- Gyorgy Bodoky
- Emiliano Calvo
- Massimo di Nicola
- Viktor Gruenwald
- Martijn Lolkema
- Nicolas Penel
- Ruth Vera