Exploring new uses for existing drugs: innovative mechanisms to fund independent clinical research

Abstract Background Finding new therapeutic uses for existing medicines could lead to safe, affordable and timely new treatment options for patients with high medical needs. However, due to a lack of economic incentives, pharmaceutical developers are rarely interested to invest in research with appr...

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Main Authors: Ciska Verbaanderd, Ilse Rooman, Isabelle Huys
Format: Article
Language:English
Published: BMC 2021-05-01
Series:Trials
Subjects:
Online Access:https://doi.org/10.1186/s13063-021-05273-x
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spelling doaj-8b4146836b254f7a8e2fb37fdada10df2021-05-09T11:30:07ZengBMCTrials1745-62152021-05-0122111310.1186/s13063-021-05273-xExploring new uses for existing drugs: innovative mechanisms to fund independent clinical researchCiska Verbaanderd0Ilse Rooman1Isabelle Huys2Department of Pharmaceutical and Pharmacological Sciences, KU LeuvenAnticancer FundDepartment of Pharmaceutical and Pharmacological Sciences, KU LeuvenAbstract Background Finding new therapeutic uses for existing medicines could lead to safe, affordable and timely new treatment options for patients with high medical needs. However, due to a lack of economic incentives, pharmaceutical developers are rarely interested to invest in research with approved medicines, especially when they are out of basic patent or regulatory protection. Consequently, potential new uses for these medicines are mainly studied in independent clinical trials initiated and led by researchers from academia, research institutes, or collaborative groups. Yet, additional financial support is needed to conduct expensive phase III clinical trials to confirm the results from exploratory research. Methods In this study, scientific and grey literature was searched to identify and evaluate new mechanisms for funding clinical trials with repurposed medicines. Semi-structured interviews were conducted with 16 European stakeholders with expertise in clinical research, funding mechanisms and/or drug repurposing between November 2018 and February 2019 to consider the future perspectives of applying new funding mechanisms. Results Traditional grant funding awarded by government and philanthropic organisations or companies is well known and widely implemented in all research fields. In contrast, only little research has focused on the application potential of newer mechanisms to fund independent clinical research, such as social impact bonds, crowdfunding or public-private partnerships. Interviewees stated that there is a substantial need for additional financial support in health research, especially in areas where there is limited commercial interest. However, the implementation of new funding mechanisms is facing several practical and financial challenges, such as a lack of expertise and guidelines, high transaction costs and difficulties to measure health outcomes. Furthermore, interviewees highlighted the need for increased collaboration and centralisation at a European and international level to make clinical research more efficient and reduce the need for additional funding. Conclusions New funding mechanisms to support clinical research may become more important in the future but the unresolved issues identified in the current study warrant further exploration.https://doi.org/10.1186/s13063-021-05273-xDrug repurposingClinical researchResearch fundingPublic-private partnershipsCrowdfundingSocial impact bonds
collection DOAJ
language English
format Article
sources DOAJ
author Ciska Verbaanderd
Ilse Rooman
Isabelle Huys
spellingShingle Ciska Verbaanderd
Ilse Rooman
Isabelle Huys
Exploring new uses for existing drugs: innovative mechanisms to fund independent clinical research
Trials
Drug repurposing
Clinical research
Research funding
Public-private partnerships
Crowdfunding
Social impact bonds
author_facet Ciska Verbaanderd
Ilse Rooman
Isabelle Huys
author_sort Ciska Verbaanderd
title Exploring new uses for existing drugs: innovative mechanisms to fund independent clinical research
title_short Exploring new uses for existing drugs: innovative mechanisms to fund independent clinical research
title_full Exploring new uses for existing drugs: innovative mechanisms to fund independent clinical research
title_fullStr Exploring new uses for existing drugs: innovative mechanisms to fund independent clinical research
title_full_unstemmed Exploring new uses for existing drugs: innovative mechanisms to fund independent clinical research
title_sort exploring new uses for existing drugs: innovative mechanisms to fund independent clinical research
publisher BMC
series Trials
issn 1745-6215
publishDate 2021-05-01
description Abstract Background Finding new therapeutic uses for existing medicines could lead to safe, affordable and timely new treatment options for patients with high medical needs. However, due to a lack of economic incentives, pharmaceutical developers are rarely interested to invest in research with approved medicines, especially when they are out of basic patent or regulatory protection. Consequently, potential new uses for these medicines are mainly studied in independent clinical trials initiated and led by researchers from academia, research institutes, or collaborative groups. Yet, additional financial support is needed to conduct expensive phase III clinical trials to confirm the results from exploratory research. Methods In this study, scientific and grey literature was searched to identify and evaluate new mechanisms for funding clinical trials with repurposed medicines. Semi-structured interviews were conducted with 16 European stakeholders with expertise in clinical research, funding mechanisms and/or drug repurposing between November 2018 and February 2019 to consider the future perspectives of applying new funding mechanisms. Results Traditional grant funding awarded by government and philanthropic organisations or companies is well known and widely implemented in all research fields. In contrast, only little research has focused on the application potential of newer mechanisms to fund independent clinical research, such as social impact bonds, crowdfunding or public-private partnerships. Interviewees stated that there is a substantial need for additional financial support in health research, especially in areas where there is limited commercial interest. However, the implementation of new funding mechanisms is facing several practical and financial challenges, such as a lack of expertise and guidelines, high transaction costs and difficulties to measure health outcomes. Furthermore, interviewees highlighted the need for increased collaboration and centralisation at a European and international level to make clinical research more efficient and reduce the need for additional funding. Conclusions New funding mechanisms to support clinical research may become more important in the future but the unresolved issues identified in the current study warrant further exploration.
topic Drug repurposing
Clinical research
Research funding
Public-private partnerships
Crowdfunding
Social impact bonds
url https://doi.org/10.1186/s13063-021-05273-x
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