Academia and industry agreement on a feasibility tool for first‐time‐in‐human clinical trial units
Abstract First‐time‐in‐human (FTIH) trials are designed to generate information on the safety, tolerability, as well as the pharmacokinetic and pharmacodynamics profile of new drugs. To ensure the safety of participants, these trials need to be conducted at specifically equipped phase I clinical tri...
| Main Authors: | , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Wiley
2023-12-01
|
| Series: | Clinical and Translational Science |
| Online Access: | https://doi.org/10.1111/cts.13655 |
| _version_ | 1797391751358447616 |
|---|---|
| author | Paloma Moraga Paula Prieto Almari Conradie Majda Benhayoun Vicki Rousell Maria Davy Uwe Fuhr Rosa Antonijoan Arbos Francisco Abad‐Santos Antonio Portolés Jolanda Van Duinen Antonio J. Carcas Alberto M. Borobia the ERA4TB Consortium |
| author_facet | Paloma Moraga Paula Prieto Almari Conradie Majda Benhayoun Vicki Rousell Maria Davy Uwe Fuhr Rosa Antonijoan Arbos Francisco Abad‐Santos Antonio Portolés Jolanda Van Duinen Antonio J. Carcas Alberto M. Borobia the ERA4TB Consortium |
| author_sort | Paloma Moraga |
| collection | DOAJ |
| description | Abstract First‐time‐in‐human (FTIH) trials are designed to generate information on the safety, tolerability, as well as the pharmacokinetic and pharmacodynamics profile of new drugs. To ensure the safety of participants, these trials need to be conducted at specifically equipped phase I clinical trial units (CTUs). In accordance with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practice (GCP) and the European Union (EU) regulatory guidelines, one of the aims of the European Regime Accelerator for Tuberculosis (ERA4TB) project is to collaboratively create a feasibility tool, through a partnership between public and private entities, for the validation of CTUs selected to conduct FTIH trials. A feasibility form, encompassing nine sections, was created to gather information on the unit in relation to key attributes of FTIH trials. Collaboratively, industry and academic partners defined the minimal criteria to ensure the adherence of CTUs to the principles of ICH GCP and regulations outlined by the European Medicines Agency (EMA) for the execution of FTIH trials. Subsequently, all CTUs available for the project were assessed for FTIH trial eligibility. The introduction of the certification procedure through the feasibility tool within ERA4TB resulted in the accreditation of the five academic CTUs, which are now prepared to carry out FTIH trials as part of the Consortium. The developed feasibility tool aims to establish open and widely used minimum requirements for the validation of academic CTUs as FTIH units, marking it as the inaugural tool for CTU validation resulting from the collaboration between industry and academia within the ERA4TB project. The established partnership has enabled an innovative and novel way of working. |
| first_indexed | 2024-03-08T23:37:13Z |
| format | Article |
| id | doaj.art-d614109e5d3743f585d46e379263ac7b |
| institution | Directory Open Access Journal |
| issn | 1752-8054 1752-8062 |
| language | English |
| last_indexed | 2024-03-08T23:37:13Z |
| publishDate | 2023-12-01 |
| publisher | Wiley |
| record_format | Article |
| series | Clinical and Translational Science |
| spelling | doaj.art-d614109e5d3743f585d46e379263ac7b2023-12-14T06:03:04ZengWileyClinical and Translational Science1752-80541752-80622023-12-0116122421242810.1111/cts.13655Academia and industry agreement on a feasibility tool for first‐time‐in‐human clinical trial unitsPaloma Moraga0Paula Prieto1Almari Conradie2Majda Benhayoun3Vicki Rousell4Maria Davy5Uwe Fuhr6Rosa Antonijoan Arbos7Francisco Abad‐Santos8Antonio Portolés9Jolanda Van Duinen10Antonio J. Carcas11Alberto M. Borobia12the ERA4TB ConsortiumClinical Pharmacology Department La Paz University Hospital, IdiPAZ Madrid SpainClinical Pharmacology Department La Paz University Hospital, IdiPAZ Madrid SpainGlobal Alliance for TB Drug Development (TB Alliance) New York New York USAGlobal Alliance for TB Drug Development (TB Alliance) New York New York USAGlaxoSmithKline London UKGlaxoSmithKline London UKDepartment of Pharmacology, Faculty of Medicine and University Hospital Cologne, Center for Pharmacology University of Cologne Cologne GermanyClinical Pharmacology Department Hospital de la Santa Creu i Sant Pau Barcelona SpainClinical Pharmacology Department, Hospital Universitario de La Princesa, Instituto Teófilo Hernando Universidad Autónoma de Madrid (UAM), Instituto de Investigación Sanitaria La Princesa (IP) Madrid SpainClinical Pharmacology Department, Hospital Clínico San Carlos Instituto de Investigación Sanitaria del Hospital Clínico San Carlos, IdISSC Madrid SpainQPS Netherlands BV Groningen The NetherlandsClinical Pharmacology Department La Paz University Hospital, IdiPAZ Madrid SpainClinical Pharmacology Department La Paz University Hospital, IdiPAZ Madrid SpainAbstract First‐time‐in‐human (FTIH) trials are designed to generate information on the safety, tolerability, as well as the pharmacokinetic and pharmacodynamics profile of new drugs. To ensure the safety of participants, these trials need to be conducted at specifically equipped phase I clinical trial units (CTUs). In accordance with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practice (GCP) and the European Union (EU) regulatory guidelines, one of the aims of the European Regime Accelerator for Tuberculosis (ERA4TB) project is to collaboratively create a feasibility tool, through a partnership between public and private entities, for the validation of CTUs selected to conduct FTIH trials. A feasibility form, encompassing nine sections, was created to gather information on the unit in relation to key attributes of FTIH trials. Collaboratively, industry and academic partners defined the minimal criteria to ensure the adherence of CTUs to the principles of ICH GCP and regulations outlined by the European Medicines Agency (EMA) for the execution of FTIH trials. Subsequently, all CTUs available for the project were assessed for FTIH trial eligibility. The introduction of the certification procedure through the feasibility tool within ERA4TB resulted in the accreditation of the five academic CTUs, which are now prepared to carry out FTIH trials as part of the Consortium. The developed feasibility tool aims to establish open and widely used minimum requirements for the validation of academic CTUs as FTIH units, marking it as the inaugural tool for CTU validation resulting from the collaboration between industry and academia within the ERA4TB project. The established partnership has enabled an innovative and novel way of working.https://doi.org/10.1111/cts.13655 |
| spellingShingle | Paloma Moraga Paula Prieto Almari Conradie Majda Benhayoun Vicki Rousell Maria Davy Uwe Fuhr Rosa Antonijoan Arbos Francisco Abad‐Santos Antonio Portolés Jolanda Van Duinen Antonio J. Carcas Alberto M. Borobia the ERA4TB Consortium Academia and industry agreement on a feasibility tool for first‐time‐in‐human clinical trial units Clinical and Translational Science |
| title | Academia and industry agreement on a feasibility tool for first‐time‐in‐human clinical trial units |
| title_full | Academia and industry agreement on a feasibility tool for first‐time‐in‐human clinical trial units |
| title_fullStr | Academia and industry agreement on a feasibility tool for first‐time‐in‐human clinical trial units |
| title_full_unstemmed | Academia and industry agreement on a feasibility tool for first‐time‐in‐human clinical trial units |
| title_short | Academia and industry agreement on a feasibility tool for first‐time‐in‐human clinical trial units |
| title_sort | academia and industry agreement on a feasibility tool for first time in human clinical trial units |
| url | https://doi.org/10.1111/cts.13655 |
| work_keys_str_mv | AT palomamoraga academiaandindustryagreementonafeasibilitytoolforfirsttimeinhumanclinicaltrialunits AT paulaprieto academiaandindustryagreementonafeasibilitytoolforfirsttimeinhumanclinicaltrialunits AT almariconradie academiaandindustryagreementonafeasibilitytoolforfirsttimeinhumanclinicaltrialunits AT majdabenhayoun academiaandindustryagreementonafeasibilitytoolforfirsttimeinhumanclinicaltrialunits AT vickirousell academiaandindustryagreementonafeasibilitytoolforfirsttimeinhumanclinicaltrialunits AT mariadavy academiaandindustryagreementonafeasibilitytoolforfirsttimeinhumanclinicaltrialunits AT uwefuhr academiaandindustryagreementonafeasibilitytoolforfirsttimeinhumanclinicaltrialunits AT rosaantonijoanarbos academiaandindustryagreementonafeasibilitytoolforfirsttimeinhumanclinicaltrialunits AT franciscoabadsantos academiaandindustryagreementonafeasibilitytoolforfirsttimeinhumanclinicaltrialunits AT antonioportoles academiaandindustryagreementonafeasibilitytoolforfirsttimeinhumanclinicaltrialunits AT jolandavanduinen academiaandindustryagreementonafeasibilitytoolforfirsttimeinhumanclinicaltrialunits AT antoniojcarcas academiaandindustryagreementonafeasibilitytoolforfirsttimeinhumanclinicaltrialunits AT albertomborobia academiaandindustryagreementonafeasibilitytoolforfirsttimeinhumanclinicaltrialunits AT theera4tbconsortium academiaandindustryagreementonafeasibilitytoolforfirsttimeinhumanclinicaltrialunits |