Streamlining clinical research: an ESMO awareness call to improve sponsoring and monitoring of clinical trials.

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.

Informations de copyright

Copyright © 2022 European Society for Medical Oncology. Published by Elsevier Ltd. All rights reserved.

Déclaration de conflit d'intérêts

Disclosure JLPG has taken part in advisory boards for Bristol Myers Squibb (BMS), Merck, Merck Sharp & Dohme (MSD), Seattle Genetics, Gilead; reports speaker honorarium from BMS, MSD, Roche; reports funding from Ipsen, Roche; reports role as principal investigator (PI) for Amgen, BMS, Roche, Seattle Genetics. NP reports a research grant from Bayer. EC has taken part in advisory boards for Adcendo, Amunix, Anaveon, AstraZeneca, BMS, Chugai, Elevation Oncology, Janssen, Monta, MSD, Nanobiotix, Nouscom, Novartis, Servier, T-knife, TargImmune; reports speaker/lecturer honorarium from OncoDNA, PharmaMar, Roche/Genentech; reports full or part-time employment by HM Hospitales Group, START Madrid; reports member of board of directors of PharmaMar; reports ownership interest in Oncoart Associated, START; reports steering committee member of BeiGene, Sanofi. AA has taken part in advisory boards from Amgen, AstraZeneca, Bayer, Daiichi, Eisai, Genomic Health, Hengrui, Innate, Ipsen, Leo Pharma, Lilly, Merck, MSD, Novartis, Pfizer, Seattle Genetics. Speaker fees from Amgen, AstraZeneca, Bayer, Daiichi, Eisai, Genomic Health, Ipsen, Leo Pharma, Lilly, Merck, MSD, Novartis, Pfizer, Seattle Genetics. Research grants from BMS, Roche. HTA has taken part in advisory boards for Beigene, iOnctura; reports speaker honorarium from Guardant, Servier; reports role as PI for multiple small and large Pharma/Biotechs. TA reports speaker honorarium from BMS, Novartis, Pierre Fabre; reports writers honorarium from CeCaVa; reports research grants from iFIT, Novartis; reports funding from NeraCare, Novartis, Sanofi, SkylineDx; reports non-financial interests in ASCO, Portuguese Society of Medical Oncology; reports other from INFARMED. VG has taken part in advisory boards for APOGEPHA, BMS, Debiopharm, Eisai, EUSA Pharma, Merck Serono, MSD, Nanobiotix, Oncorena, PCI Biotech, Pfizer, Roche; reports speaker honorarium from Astellas, AstraZeneca, BMS, Eisai, Ipsen, Janssen-Cilag, Merck Serono, MSD, Novartis, Pfizer, Roche; reports stocks/shares in AstraZeneca, BMS, MSD, Seattle Genetics; reports research grants from BMS, Ipsen, MSD, Pfizer; reports steering committee member for BMS, Eisai, Ipsen, Novartis; reports trial chair for PharmaMar; reports non-financial interests in ASCO, German Cancer Society, German medical Oncology and Hematology Society, Working Group medical oncology. MFS has taken part in an advisory board for Numab; reports speaker honorarium from MSD; reports a research grant from Roche; reports non-financial interests in BMS. GB has taken part in advisory boards for Janssen, Merck, Novartis, Roche, Servier. MPL has taken part in advisory boards for Amgen, Astellas, AstraZeneca, Bayer, INCa, Janssen-Cilag BV, MSD, Novartis, Pfizer, Roche, Sanofi, Servier; reports consulting role for Julius Clinical; reports research grants from Astellas, Janssen, MSD, Sanofi. MDN reports PI roles in studies sponsored by Amgen, BMS, Mundipharma, Novartis, Roche, Sanofi, Merck, Nektar Therapeutics, Incyte, Genentech, Beigene, Hookipa. PGC reports institutional research/educational funds from: Advenchen Laboratories, Amgen Dompé, AROG Pharmaceuticals, Bayer, Blueprint Medicines, Daiichi Sankyo, Deciphera, Eisai, Eli Lilly, Epizyme Inc, Glaxo, Karyopharm Pharmaceuticals, Novartis, Pfizer, PharmaMar. RG reports being a past core member of the European Medicines Agency (EMA) Scientific Advisory Group-Oncology (SAG-O, 2012-2021), member of the EMA Healthcare Professional Working Party and of the EMA Cancer Medicines Forum; an expert evaluator of proposal submitted to EU Commission on prevention (2020) and on artificial intelligence (2022); member of the Health Technology Assessment stakeholders group, former HTAN, and of the EUnetHTA stakeholder group; member of the steering committee of the World Health Organization (WHO) Decide Health Decision Hub; member of the Cancer Drug Development forum. She also provided consultation/lectures (no remuneration) for Novartis, Mylan, Roche, Lilly, Apogen, Pfizer and medicines for Europe and institutional financial support (clinical trials, Italy—2018) for MDS and Novartis. GP has taken part in advisory boards for Amgen, AstraZeneca, BMS, Lilly, Merck, MSD, Roche; reports role as PI for AbbVie, Amgen, AstraZeneca, Boehringer Ingelheim, BMS, Debiopharm, Ipsen, Lilly, Merck, MSD, Roche, Servier; reports grants from Amgen, AstraZeneca, Roche; reports funding from Boehringer Ingelheim, BMS, Enorasis, Genekor, Ipsen, Janssen, Merck, MSD, Pfizer, Sanofi, Servier. LCB has declared no conflicts of interest.