Investigator-initiated Clinical Trials Conducted By The Portuguese Clinical Research Infrastructure Network (PtCRIN)

Authors:C.Madeira, A.Pais, C.Kubiak, J.Demotes, E.C.Monteiro

Abstract:

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.

Keywords

Academic clinical trials; Investigator-initiated clinical trials; Clinical trial unit; ECRIN; PtCRIN; Infrastructure

Citation: C.Madeira, A.Pais, C.Kubiak, J.Demotes, E.C.Monteiro Investigator-initiated Clinical Trials Conducted By The Portuguese Clinical Research Infrastructure Network (PtCRIN)

Received: 20 April 2016, Revised: 3 July 2016, Accepted: 10 August 2016, Available online: 20 August 2016

Copyright: © 2016 Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND license(http://creativecommons.org/licenses/by-nc-nd/4.0/).

Conclusions

The first steps towards high-quality IICTs in Portugal have been taken through membership in ECRIN. Although PtCRIN's scientific output is far from the desired result, we foresee that being a scientific partner of ECRIN will increase performance in the next few years. Our results might trigger the development of similar studies in other European countries seeking to confirm ECRIN's added value and produce accurate comparative studies in IICTs. The engagement of national governments in building the capacity of infrastructures dedicated to managing interventional IICTs at non-profit rates is, in our view, crucial to achieve high-quality evidence in health technologies to improve health care and the sustainability of health systems.

Conflict of interest statement

None.

Contributors

AP and EM conducted the survey with the representative of each PtCRIN member and AP and CM conducted the face-to-face interviews. CM performed the clinical trials and publications search, screening and results analyses. All authors contributed to the preparation and review of the manuscript.

Acknowledgements

We would like to acknowledge the kindness of Prof. Alexandra Ribeiro and availability of Dr. Filipa Oliveira and Dr. Raquel Silva from Comissão de Ética para a Investigação Clínica (CEIC) for providing the name of the research sites for each ongoing investigator-initiated clinical trial registered in Portugal and also the number of clinical trials per institution. We also want to acknowledge all representatives of PtCRIN member for the information provided in the survey and interviews. The authors also want to acknowledge Sabrina Gaber for the professional editing of this manuscript. The work of CM and AP is being supported by Fundação para a Ciência e a Tecnologia (FCT, through the membership fees to ECRIN-ERIC published at Portaria n.º 237/2014).

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