D15.2. Mapping of organisations providing support to multicountry IICS

This deliverable is an outcome of Task 2B.2.2-Mapping of organisations supporting the planning, design and conduct of multicountry Investigator Initiated Clinical Studies (IICS) at national and European level.

This mapping describes organisations that have developed a capacity to design and manage multicountry studies in Europe.

Purpose and objectives

Specific objectives of this deliverable are:

1.  Identify organisations able to support IICS at national and international level
2.  Describe their support capacity and services offered

Intended audience

The deliverable will be made public, as the intended audience will be:

1. General public/clinical research community
2. Future applicants to ERA4Health calls in IICS
3. ERA4Health partners

Methodology

In order to identify how non-commercial organisations support IICs in Europe, 2 online surveys were used (Survey 1, part B and Survey 2). They were designed in the Research Electronic Data Capture (RedCAP)2,3 platform and divulged, through relevant stakeholders, to non-commercial organisations supporting IICS located in or outside of Europe. The list of potential participants for each Country was identified by the European Correspondents (EuCos) of the European Clinical Research Infrastructure Network (ECRIN) (Survey 2) and public clinical research funders (Survey 1, Part B). The survey contained questions to collect detailed information related to the opportunities offered by those organizations, infrastructures or Networks (national or regional) regarding the planning, design and conduct of multicountry IICS at national and European level.

Results

By analysing both surveys, 92 non-private organisations, infrastructure or network organisations have been identified. A high percentage (n 38) of the participants in the survey indicated the capability of their organisation to support Intervention trials, followed by Non-interventional studies (n 31), Low intervention trials and Comparative effectiveness trials (n 28). Only 42 out of 92 provided a description of the IICS support, including funding, technical assistance, sponsorship, recruitment support, scientific advice, and assistance with clinical operations.

Responders identified several key obstacles hindering the development of IICS. These obstacles include a lack of funding for multinational clinical studies (29 responses), insufficient funding for multinational research networks (26 responses), inadequate support for clinical study infrastructures (26 responses), inadequate funding for multinational research projects (24 responses), and inadequate multinational funding mechanisms (18 responses). Collected suggestions on how ERA4Health can enhance and facilitate the implementation of clinical studies are included in the text.

Conclusion

There is a considerable number of institutions supporting IICS in Europe most of them addressing intervention trials, non-interventional studies and low intervention trials. They offer diverse types of support ranging from Sponsorship to Scientific Support or Clinical operations with only few organizations able to provide the full range of services. These outcomes provide valuable insights describing the specific support that organisations might provide to IICS applicants and can inform decision-making and resource allocation in future research ERA4Health calls for IICS. Furthermore, the indications collected will be highly useful for future applicants to ERA4Health calls in IICS.

Main recommendation

Based on the collected information, the main recommendations for improving and facilitating the implementation of IICSs include:

- enhancing the establishment of interoperable national and European infrastructures for IICS. Considering that not all described organizations are able to provide the full set of services/support needed to implement efficiently IICs, collaboration and interoperability is key. We recommend ERA4Health partners broad communication about the possibilities offered by these organizations for future applicants to ERA4Health calls on IICs. Furthermore, we encourage ERA4Health funders to consider the inclusion of some of these organizations in the plans for implementing proactive measures to ensure the quality of the future applications (Deliverable D2B41).

- Adapt the funding mechanisms of the future ERA4Health call on IICs to make more suitable the use of these already existing supporting organizations, either in the planning phase, in the implementation phase or both.

2Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap) – A metadata-driven methodology and workflow process for providing translational research informatics support, J Biomed Inform. 2009 Apr;42(2):377-81. http://www.sciencedirect.com/science/article/pii/S1532046408001226

3Harris PA, Taylor R, Minor BL, Elliott V, Fernandez M, O’Neal L, McLeod L, Delacqua G, Delacqua F Kirby, J, Duda SN. REDCap Consortium, The REDCap consortium: Building an international community of software partners, J Biomed Inform. 2019 May 9 [doi: 10.1016/j.jbi.2019.103208] https://www.sciencedirect.com/science/article/pii/S1532046419301261