ESMO Clinical Research Observatory (ECRO): improving the efficiency of clinical research through rationalisation of bureaucracy

Abstract

acknowledgements We are indebted to Klizia Marinoni for her support in coordinating the activities of the group; and to Paul Miller for revising the manuscript.

Oncology clinical trials during the COVID-19 outbreak: Lessons learnt during the crisis and future opportunities

“…To be precise, in recent years, the delegation of many activities like trial set-up and monitoring through CROs not only added another layer of complexity between investigators and sponsors, but also added a number of extra-requirements which significantly increased the level of operational burden [4]. Although patients' safety remains the utmost priority, the GCP principles did not change significantly since the Declaration of Helsinki in 1964, but in contrast, an exponential increase affecting trial set-up efforts, trial execution procedures, data recording, monitoring and auditing has been observed [5,6].…”

Reimagining Global Oncology Clinical Trials for the Postpandemic Era: A Call to Arms

“…Regulators, such as the US Food and Drug Administration 41 ; health systems, like the United Kingdom National Health Service 42 ; professional oncology societies, such as the European Society of Medical Oncology and the American Society of Clinical Oncology 30 , 43 ; academicians; and industry should continue to make efforts to streamline clinical research and reduce the burden of paperwork. 44 It is a challenge for principal investigators to sign off and act as guarantor for electronic case record forms and multiple serious adverse event reports; it is important that investigator oversight is not diluted by collecting ever-increasing volumes of data for which they are not easily equipped to vouch and certify.…”

Beyond the lessons learned from the COVID-19 pandemic: opportunities to optimize clinical trial implementation in oncology

“…Even before the COVID-19 pandemic, important barriers impacted on the conduct of clinical trials ( 18 , 19 , 20 ). Different research groups have been proposing a number of solutions in order to remedy the complex, and at times dysfunctional reality of clinical cancer research ( 19 , 20 , 21 , 22 ).…”

“…Even before the COVID-19 pandemic, important barriers impacted on the conduct of clinical trials ( 18 , 19 , 20 ). Different research groups have been proposing a number of solutions in order to remedy the complex, and at times dysfunctional reality of clinical cancer research ( 19 , 20 , 21 , 22 ). To add to this background, clinical research activities were seriously impaired at the beginning of the SARS-CoV-2 pandemic resulting in many sites struggling to maintain their trial activity and to start new studies ( 18 , 23 , 24 , 25 ).…”

“…In a recent survey by the ESMO Clinical Research Observatory (ECRO), clinical investigators (n =940) strongly agreed on the excessive burden of administrative tasks that reflect negatively on the quality of clinical research ( 19 ). While adherence to international guidelines such as the Helsinki Declaration and Good Clinical Practice (GCP) regulations are sine qua non, their overinterpretation may undermine the efficiency in all clinical research processes.…”