Abstract 588P
Background
Biomarkers in clinical trials as well as the need for correlative studies have led to the massive incorporation of research biopsies and archival tissue collection, with potentially risks and no direct benefit for patients. In 2019, ASCO has released an ethical framework (Levit LA et al. JCO 2019) to provide guidance on incorporating research biopsies in clinical trials.
Methods
We collected biopsy requirements of oncological clinical trials conducted at IJB between 2015 and 2019 to examine adherence with the ASCO Ethical Framework. We used logistic regression models to test the association between the request for biopsy, the request for tissue and the adherence to ASCO framework and some trials characteristics.
Results
Between January 2015 and December 2019, 178 studies were conducted at IJB. 138 (78%) were sponsored by industry, 132 (74%) were phase II and III studies and 141 (79%) involved metastatic disease. Tissue was required for inclusion, including archival tissue or new biopsy, for 119 (67%) studies. New biopsies were mandatory in 59 (33%) studies. Among those requesting more than one mandatory biopsy (N=25), 84% did not follow ASCO’s framework. Additional characteristics of biopsies and informed consent documents are displayed in the table. In multivariate analysis, the request for tissue or new biopsies increased in early phase studies (p<0.001, p<0.001 respectively) and in studies investigating innovative treatments (immunotherapy or targeted therapies) (p<0.01, p=0.02). Compliance to ASCO framework decreased with time (p<0.001) and in early phase studies (p<0.001). Table: 588P
| Studies requiring tissue (n=119) | Studies requiring mandatory biopsies (n=59) | |
| Sponsor Academic Industry | 22 (18%) 97 (82%) | 9 (15%) 50 (85%) |
| Early-phase studies | 41 (34%) | 29 (49%) |
| Number of mandatory biopsies 0 1 2 3 | 60 (50%) 34 (29%) 23 (19%) 2 (2%) | 0 34 (58%) 23 (39%) 2 (3%) |
| Biomarkers Expected utility: necessary for inclusion or primary objective Potential utility: necessary for secondary objective Unknown utility: necessary for exploratory objective | 52 (44%) 5 (4%) 62 (52%) | 19 (32%) 4 (7%) 36 (61%) |
| Adherence with ASCO Ethical Framework | 80 (67%) | 23 (39%) |
| Consent Characteristics Risk mentioned Benefit mentioned | 66 (55%) 75 (63%) | 41 (70%) 38 (64%) |
Conclusions
Numerous studies required tissue or new biopsies for exploratory objectives of unknown clinical utility. Request for tissue increases through years whereas compliance to ASCO’s Framework decreases. Future studies should follow ASCO’s Ethical Framework whose aim is to improve the ethics of research biopsies.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
C. Jungels: Travel/Accommodation/Expenses: Pharmamar; Travel/Accommodation/Expenses: Ipsen; Travel/Accommodation/Expenses: Bayer. A.H. Awada: Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Roche; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Lilly; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Amgen; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Eisai; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): BMS; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Pfizer; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Novartis; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): MSD; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Genomic Health; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Ipsen; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): AstraZenaca; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Bayer; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Leo Pharma; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Merck. P.G. Aftimos: Travel/Accommodation/Expenses: Boehringer Ingelheim; Travel/Accommodation/Expenses: Macrogenics; Travel/Accommodation/Expenses: Amcure; Travel/Accommodation/Expenses: Synthon; Travel/Accommodation/Expenses: Radius; Travel/Accommodation/Expenses: Servier; Travel/Accommodation/Expenses: G1 therapeutics; Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Travel/Accommodation/Expenses: Novartis; Advisory/Consultancy, Travel/Accommodation/Expenses: Amgen; Advisory/Consultancy: MSD; Advisory/Consultancy: Pfizer. All other authors have declared no conflicts of interest.