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.

OBJECTIVES: Clinical 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. METHODS: A 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. RESULTS: IICTs 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%). CONCLUSION: The 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.

Raising standards in clinical research - The impact of the ECRIN data centre certification programme, 2011-2016.

The nature and the purpose of the ECRIN Data Centre Certification Programme are summarised, and a very brief description is given of the underlying standards (129 in total, divided into 19 separate lists). The certification activity performed so far is described. In a pilot phase 2 centres were certified in 2012. Calls in 2014 and 2015 resulted in a further 8 certified centres, with 2 certifications still in progress, and the 2016 call has generated several additional applications. The impact and benefits of the programme are listed, divided into a) the effects of the introduction of the standards, b) the effects of the certification programme in general, and c) the effects of the certification programme on individual units. The discussion emphasises the generally positive impact of the programme so far but stresses the need to better clarify the perspective and role of the programme.

Investigator-initiated clinical trials conducted by the Portuguese Clinical Research Infrastructure Network (PtCRIN).

Interventional clinical studies can provide the highest levels of evidence and generate significant results on specific investigational medicinal products or medical devices. In order to have powerful studies, attain unquestionable results and make significant discoveries, the number of patients enrolled must be high. Therefore, multinational, randomised clinical trials are necessary. The multicentre, multinational recruitment of subjects in investigator-initiated clinical trials (IICTs) increases their logistical burden, justifying the need for specific infrastructures to ease implementation. Herein, we provide for the first time an overview of the facts and figures concerning IICTs, existing infrastructures' capacity for interventional clinical research, and scientific performance of investigators in a European country, Portugal. We aim to highlight the relevance and need for investing in European infrastructures such as the European Clinical Research Infrastructure Network (ECRIN) for multinational IICTs. A public, non-profit organisation, ECRIN facilitates the conduct of multinational clinical trials in Europe by coordinating scientific partners and their networks, and providing advice, management services and tools to enhance collaboration. Currently in Portugal, few multinational randomised IICTs are coordinated by national investigators. This is most likely due to the lack of human resources dedicated to clinical trials in clinical research centres (CRCs) as well as the scarcity of professional academic clinical trial units (CTUs) providing logistics and management services at non-profit rates. With the data shown, we expect to trigger the development of similar studies in other European countries and stress the impact of government support for IICTs.