Patients' selection and trial matching in early-phase oncology clinical trials.

BACKGROUND

Early-phase clinical trials (EPCT) represent an important part of innovations in medical oncology and a valuable therapeutic option for patients with metastatic cancers, particularly in the era of precision medicine. Nevertheless, adult patients' participation in oncology clinical trials is low, ranging from 2% to 8% worldwide, with unequal access, and up to 40% risk of early discontinuation in EPCT, mostly due to cancer-related complications.

DESIGN

We review the tools and initiatives to increase patients' orientation and access to early phase cancer clinical trials, and to limit early discontinuation.

RESULTS

New approaches to optimize the early-phase clinical trial referring process in oncology include automatic trial matching, tools to facilitate the estimation of patients' prognostic and/or to better predict patients' eligibility to clinical trials. Classical and innovative approaches should be associated to double patient recruitment, improve clinical trial enrollment experience and reduce early discontinuation rates.

CONCLUSIONS

Whereas EPCT are essential for patients to access the latest medical innovations in oncology, offering the appropriate trial when it is relevant for patients should increase by organizational and technological innovations. The oncologic community will need to closely monitor their performance, portability and simplicity for implementation in daily clinical practice.

Informations de copyright

Copyright © 2024. Published by Elsevier B.V.

Déclaration de conflit d'intérêts

Declaration of Competing Interest LV: reports personal fees from Adaptherapy, is CEO of RESOLVED, has received non-personal fees from Pierre-Fabre and Servier, and a grant from Bristol-Myers Squibb, all outside the submitted work AB is the CEO and co-founder of Klinéo PAC received consulting/honoraria by Boehringer Ingelheim Ose Immunotherapeutics, Bristol Meyer Squibb As Principal-Investigator in the Phase 1 unit at CLB of Clinical Trials the relations are: AV with Astra Zeneca, BIONTECH RNA, EXSCIENTA LTD, Exelixis, Hoffmann La Roche Ag, IPSEN, Janssen Cilag, Kinnate Biopharma, Lilly France, Loxo Oncology, Novartis, TAKEDA LV with Genmab, Bicycle Therapeutics, Revolution Medicine, Daiichi, Astra Zeneca, Hoffmann La Roche PAC with Abbvie, Adlai Nortye, Alligator, Amgen, Boehringer Ingelheim, Blueprint, Bristol Meyer Squibb, Debio, Dragonfly, Exelixis, Incyte, Iteos, Janssen, Kinnate, Kazia, Lilly/Loxo, Merck Sharp Dohme, Molecular Partners, Novartis, Ose immunotherapeutics, Pierre Fabre, Relay, Roche/Genentech, Sotio, Taiho, Tango, Toray, Turning Point, Transgene. As part of the Drug Development Department (DITEP) at Gustave Roussy CB, KO, and AB declare being/having: Principal/sub-Investigator of Clinical Trials for Abbvie, Adaptimmune, Adlai Nortye USA Inc, Aduro Biotech, Agios Pharmaceuticals, Amgen, Astra Zeneca Ab, Astra Zeneca, Aveo, Basilea Pharmaceutica International Ltd, Bayer Healthcare Ag, Beigene, BicycleTx Ltd, Blueprint Medicines, Boehringer Ingelheim, Boston Pharmaceuticals, Bristol Myers Squibb, Ca, Casi Pharmaceuticals, Inc, Cato Research, Celgene Corporation, Cellcentric, Chugai Pharmaceutical Co, Cullinan-Apollo, Daiichi Sankyo, Debiopharm, Eisai, Eisai Limited, Eli Lilly, EverImmune, Exelixis, Faron Pharmaceuticals Ltd, Foghorn Therapeutics Inc, Forma Tharapeutics, Gamamabs, Genentech, Genmab, Glaxosmithkline, H3 Biomedicine, Hoffmann La Roche Ag, IGM Biosciences, Imcheck Therapeutics, Incyte Corporation, Innate Pharma, Iris Servier, Iteos Belgium SA, Janssen Cilag, Janssen Research Foundation, Janssen R&D LLC, K-Group Beta, Kinnate Biopharma, Kura Oncology, Kyowa Kirin Pharm. Dev, Lilly France, Loxo Oncology, Medimmune, Menarini Ricerche, Merck Sharp & Dohme Chibret, Merus, Molecular Partners Ag, Nanobiotix, Nektar Therapeutics, Novartis Pharma, Nuvalent, Octimet Oncology Nv, Oncoethix, Oncopeptides, Orion Pharma, Ose Pharma, Pfizer, Pharma Mar, Phio Pharmaceuticals Corp, Pierre Fabre Medicament, Pyramid Bioscience, Regeneron Pharmaceuticals, Relay Therapeutics, Roche, Sanofi Aventis, Seattle Genetics, Sotio A.S, Syros Pharmaceuticals, Taiho Pharma, Tesaro, Transgene S.A, Turning Point Therapeutics, Xencor Research Grants from Astrazeneca, BMS, Boehringer Ingelheim, Celsius, EIT Philips, GSK, INCA, IDERA, Janssen, Lombard, Merck, MedImmune, Pierre Fabre, Roche, Sanofi, Servier Non-financial support (drug supplied) from Astrazeneca, BMS, Boringher Ingelheim, GSK, Idera, Medimmune, Merck, NH Theraguix, Roche All other authors don’t declare any conflict of interest.