Funding multinational investigator-initiated clinical studies in Europe: why and how?

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216224%3A90034%2F24%3A00138395" target="_blank" >RIV/00216224:90034/24:00138395 - isvavai.cz</a>

Result on the web

<a href="https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-024-08548-1" target="_blank" >https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-024-08548-1</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1186/s13063-024-08548-1" target="_blank" >10.1186/s13063-024-08548-1</a>

Result language

angličtina

Original language name

Funding multinational investigator-initiated clinical studies in Europe: why and how?

Original language description

Investigator-initiated clinical studies (IICSs), also referred to as non-commercial, academic or independent clinical studies, address important research questions that are usually neglected by industry despite their high societal value. Indeed, industry may direct their focus and resources on studies that will yield results and products that can ultimately generate revenue for the company. Conversely, IICS research questions include (a) refining or getting new indications of available treatments (drug repurposing); (b) optimisation, by comparing various health products or treatment regimens; and (c) innovation, especially for advanced therapies. Multinational IICSs increase the scientific quality of the data by exchange of research ideas, scientific techniques and tools. Participation of patients from different geographical, social and ethnic backgrounds equally adds to the value of study results and yields more generalisable evidence than a study confined to a single geographical location. Multinational IICSs are generally sponsored by non-profit/academic organisations and publicly funded. Funding has been already identified as a main challenge for the conduct IICS and especially for clinical trials (IICTs, IICS where a medical intervention is directly tested). Main barriers to the conduct of multinational IICTs with public funding include: Limitations of budget and duration of the eligibility of costs Lack of flexibility to move funds transnationally Tendering rules Complexity in the reporting of the eligible costs to funders We describe why there is a need to support multinational IICS, what should be their objectives and what are the current funding mechanisms in Europe. Strategies for funding multinational IICS should evolve to mitigate identified barriers, thus facilitating research that can provide answers to highly relevant questions in healthcare which are less likely to be answered by studies funded by the pharmaceutical and medical device industry.

Czech name

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Czech description

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Type

J_imp - Article in a specialist periodical, which is included in the Web of Science database

CEP classification

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OECD FORD branch

30230 - Other clinical medicine subjects

Project

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Continuities

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Publication year

2024

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

Clinical Trials and Meta-analysis/Clinical Trials Journal

ISSN

0927-5401

e-ISSN

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Volume of the periodical

25

Issue of the periodical within the volume

1

Country of publishing house

GB - UNITED KINGDOM

Number of pages

7

Pages from-to

1-7

UT code for WoS article

001338951900002

EID of the result in the Scopus database

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