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

J 2024

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

MARTA, del Alamo; Sabrina LEMERET; Cristina NIETO; Lara PANDYA; Hans HAGEN et. al.

Základní údaje

Originální název

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

Autoři

MARTA, del Alamo; Sabrina LEMERET; Cristina NIETO; Lara PANDYA; Hans HAGEN; Saul WALKER a Jacques DEMOTES

Vydání

Clinical Trials and Meta-analysis/Clinical Trials Journal, LONDON, Elsevier, 2024, 0927-5401

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30230 Other clinical medicine subjects

Stát vydavatele

Velká Británie a Severní Irsko

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Kód RIV

RIV/00216224:90034/24:00138395

Organizační jednotka

CZECRIN

DOI

https://doi.org/10.1186/s13063-024-08548-1

UT WoS

001338951900002

Klíčová slova česky

Academic; Trials; Funding; Studies; Non-commercial

Klíčová slova anglicky

Academic; Trials; Funding; Studies; Non-commercial

Štítky

CZECRIN, ECRIN, RIV, user, článek v časopise

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 27. 2. 2025 10:17, Bc. Hana Vladíková, BBA

Anotace

V originále

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.

Návaznosti

90249, velká výzkumná infrastruktura

Název: CZECRIN IV

Citovat

MARTA, del Alamo; Sabrina LEMERET; Cristina NIETO; Lara PANDYA; Hans HAGEN; Saul WALKER a Jacques DEMOTES. Funding multinational investigator-initiated clinical studies in Europe: why and how? Clinical Trials and Meta-analysis/Clinical Trials Journal. LONDON: Elsevier, 2024, roč. 25, č. 1, s. 1-7. ISSN 0927-5401. Dostupné z: https://doi.org/10.1186/s13063-024-08548-1.

@article{2466301,
   author = {Marta, del Alamo and Lemeret, Sabrina and Nieto, Cristina and Pandya, Lara and Hagen, Hans and Walker, Saul and Demotes, Jacques},
   article_location = {LONDON},
   article_number = {1},
   doi = {https://doi.org/10.1186/s13063-024-08548-1},
   keywords = {Academic; Trials; Funding; Studies; Non-commercial},
   language = {eng},
   issn = {0927-5401},
   journal = {Clinical Trials and Meta-analysis/Clinical Trials Journal},
   title = {Funding multinational investigator-initiated clinical studies in Europe: why and how?},
   url = {https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-024-08548-1},
   volume = {25},
   year = {2024}
}

TY  - JOUR
ID  - 2466301
AU  - Marta, del Alamo - Lemeret, Sabrina - Nieto, Cristina - Pandya, Lara - Hagen, Hans - Walker, Saul - Demotes, Jacques
PY  - 2024
TI  - Funding multinational investigator-initiated clinical studies in Europe: why and how?
JF  - Clinical Trials and Meta-analysis/Clinical Trials Journal
VL  - 25
IS  - 1
SP  - 1-7
EP  - 1-7
PB  - Elsevier
SN  - 09275401
KW  - Academic
KW  - Trials
KW  - Funding
KW  - Studies
KW  - Non-commercial
UR  - https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-024-08548-1
N2  - 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.
ER  -

MARTA, del Alamo; Sabrina LEMERET; Cristina NIETO; Lara PANDYA; Hans HAGEN; Saul WALKER a Jacques DEMOTES. Funding multinational investigator-initiated clinical studies in Europe: why and how? \textit{Clinical Trials and Meta-analysis/Clinical Trials Journal}. LONDON: Elsevier, 2024, roč.~25, č.~1, s.~1-7. ISSN~0927-5401. Dostupné z: https://doi.org/10.1186/s13063-024-08548-1.

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