Investigator Initiated Clinical Trials (IICTs): A Systematic Search in Registries to Compare the Czech Republic and Portugal in Terms of Funding Policies and Scientific Outcomes

C Madeira,E C Monteiro,J Demotes,J R Batuca,K Nebeska,L Součková,C Kubiak,R Demlová,F Dos Santos,L Hořavová

doi:10.1007/s43441-021-00293-w

Abstract

ObjectivesClinical trials provide one of the highest levels of evidence to support medical practice. Investigator initiated clinical trials (IICTs) answer relevant questions in clinical practice that may not be addressed by industry. For the first time, two European Countries are compared in terms of IICTs, respective funders and publications, envisaging to inspire others to use similar indicators to assess clinical research outcomes.MethodsA retrospective systematic search of registered IICTs from 2004 to 2017, using four clinical trials registries was carried out in two European countries with similar population, GDP, HDI and medical schools but with different governmental models to fund clinical research. Each IICT was screened for sponsors, funders, type of intervention and associated publications, once completed.ResultsIICTs involving the Czech Republic and Portugal were n = 439 (42% with hospitals as sponsors) and n = 328 (47% with universities as sponsors), respectively. The Czech Republic and Portuguese funding agencies supported respectively 61 and 27 IICTs. Among these, trials with medicinal products represent 52% in Czech Republic and 4% in Portugal. In the first, a higher percentage of IICTs’ publications in high impact factor journals with national investigators as authors was observed, when compared to Portugal (75% vs 15%).ConclusionThe better performance in clinical research by Czech Republic might be related to the existence of specific and periodic funding for clinical research, although further data are still needed to confirm this relationship. In upcoming years, the indicators used herein might be useful to tracking clinical research outcomes in these and other European countries.

Highlights

In the last decades, clinical research played a crucial role on increasing the medical knowledge for the prevention, diagnostic, treatment and cure of diseases
A total of 3496 and 1427 registrations were found in the four clinical trial registries (CTRs) involving the Czech Republic and Portuguese institutions, respectively: ClinicalTrials.gov, European Clinical Trials Registry (EU-CTR), International Standard Randomised Controlled Trial Number (ISRCTN), and Australian New Zealand Clinical Trials Registry (ANZCTR)
Two European Countries were compared in terms of the number of initiated clinical trials (IICTs), funders and the respective scientific outcome

Summary

Introduction

Clinical research played a crucial role on increasing the medical knowledge for the prevention, diagnostic, treatment and cure of diseases. Clinical trials provide one of the highest levels of evidence to support medical practice and might be initiated by the industry or by clinical investigators. The latter, commonly called investigator-initiated clinical trials (IICTs), are interventional studies using medicinal products, medical devices, surgery techniques, behavior testing or several types of procedures. These trials are pivotal to generate relevant and unbiased data decisive for the implementation of new therapies and better-informed decisions by health regulators [1]. A systematic review of 1140 studies demonstrated that industry-sponsored clinical trials were significantly more likely to reach conclusions favorable to the sponsors than those who were not industry-sponsored trials [2]

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