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Clinical Benefit of Genetic Biomarkers for Guiding Treatment Decisions in Oncology Drugs

A

Assistance Publique - Hôpitaux de Paris

Status

Withdrawn

Conditions

Neoplasms

Treatments

Drug: Drug selected in the study

Study type

Observational

Funder types

Other

Identifiers

NCT02458040
BENEBIO01
PHRCK14-051 (Other Grant/Funding Number)

Details and patient eligibility

About

This study is a meta-epidemiological study which aim is to quantify the clinical benefit of the biomarker-based strategy compared to conventional strategy across all drugs with such a strategy.

Full description

Personalized medicine consist to differentially treat patients based on their individual characteristics (mainly genetics). It is of the most promising area of cancer research and cancer care. The label of more than 140 FDA- approved drugs mention a biomarker, the majority being indicated in oncology. However, it has also been suggested that the hopes of personalized medicine were not matched by evidence. Indeed, there is a threat that genetic biomarkers are used without evidence that this use translates in improved outcomes for patients, and the use of biomarkers is in need for thorough validation.

In a previous work the investigators showed that the mention of a pharmacogenomic biomarker in a drug label can have different meanings depending on the drug, and that oncology had higher proportion of required or recommended genetic testing compared to other therapeutic areas. Hence, the investigators will include only the drug-biomarker pairs with (i) required or recommended genetic testing, or (ii) with biomarker-based indication and (iii) with at least one indication in oncology.

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • phase II or III randomized clinical trials
  • including patients with one of the drug-biomarker-indication triplet studied
  • evaluating treatment effect in biomarker-defined strata (either in biomarker-positive patients, in biomarker-negative patients or in both strata).
  • reporting OS or PFS or DFS

Exclusion criteria

  • None

Trial design

0 participants in 3 patient groups

Biomarker-positive patients
Treatment:
Drug: Drug selected in the study
Biomarker-negative patients
Treatment:
Drug: Drug selected in the study
All patients
Treatment:
Drug: Drug selected in the study

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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