European survey on national training activities in clinical research

Investigator-initiated clinical studies (IITs) help to answer questions that clinicians face in their day-to-day practice. They are initiated and managed in a non-commercial setting by a researcher/s (individual investigator, academic institution, a collaborative study group, etc). IITs play a vital role in the generation of evidence that can eventually drive policy. A good IIT is one that asks a question that has scientific merit, has robust research methodology, has rigorous ethical and scientific governance, a committed and motivated investigator, institutional support, a funding agency that recognizes the value of the research and a team that backs him/her up [1]. However, there are many challenges posed by an IIT, as has recently been shown with the example of Portugal. Besides limited funds and missing local infrastructure, a lack of trained study personnel is seen as a major hurdle [2, 3]. More and more, IITs need to be multinational (e.g. in order to recruit sufficient numbers of patients), which increases their complexity.

Many important publications have emphasised and confirmed the importance of training and education to improve the quality, impact and efficiency of clinical research in general. The Lancet series on “Research: increasing value, reducing waste” [4‐8] mentions that training and education are important measures for increased impact of clinical research results on medical therapies. The OECD says that support for and facilitation of the education, training and infrastructure required for academic clinical trials are key elements of the success of clinical research [9]. Qualified and experienced staff are essential at several levels for conducting clinical trials, as the German Scientific Council states [10].

But what does the European landscape for training in clinical research look like? The National Scientific Partners of the European Clinical Research Infrastructure Network (ECRIN) are a major provider of training in clinical research and well informed on activities in their own countries. Therefore, a survey in ECRIN member and observer countries was performed to map the status of training activities at the national level in the National Scientific Networks. However, considerable heterogeneity between the partners with respect to involvement in national training activities has been reported. ECRIN is a sustainable, non-profit, distributed infrastructure with the legal status of a European Research Infrastructure Consortium (ERIC). The vision of ECRIN is to generate scientific evidence with a focus on IITs to optimise medical standards of care. To this end, ECRIN supports investigators and (mainly) academic sponsors in the planning and design of multinational clinical research [11]. ECRIN has nine member countries and two observer countries (Table 1).

Scientific partners of ECRIN are national clinical research networks that are composed of academic clinical research centres (CRCs) or clinical trial units (CTUs) with a national coordinating centre (Table 1) [12]. As per ECRIN-ERIC statutes, the scientific partners must have developed shared tools, procedures and practices to facilitate multi-centre studies, have reached a critical mass in competence and represent the standard in the country [13].

Objectives of the survey:

In Additional file 1 a longer description of ECRIN is included.

The survey was initiated in April 2018. A first version of the questionnaire was sent to the ECRIN members on 20 April 2018. The answers were compiled and presented at the NC meeting on 14 May 2018. It was decided to provide a first internal report and to give the individual countries the opportunity to go back to the questions and complete/update if needed.

As a consequence, the interim report and an updated questionnaire with a more standardised answer format were distributed to the members of the NC on 15 June 2018 with a deadline of 13 July 2018. On 14 August 2018, a reminder was sent to countries which had not yet provided the filled-in questionnaire. On 4 October 2018 the second round of data collection was completed and the next version of the report was finalised on 19 October 2018. The information provided was considered being of high value, but still too heterogenous to be shared with a broader audience. Therefore, the NC agreed to perform a third revision of the report, which was completed in January 2019.

The European countries included all have academic training opportunities in clinical research, but to different extents. The respondents are open to foster the exchange of expertise and experience in national training in clinical research as well as for a more active role of ECRIN to identify new fields of action, increasing the quality and efficiency of multinational clinical research.

The investment of the national and local networks in training and education is substantial and impressive. But so far, building up training and education programmes is rather a bottom-up process serving current needs. Furthermore, there are few systematic approaches for (top-down) strategic and overarching considerations, active promotion and cross-network exchange. However, the EU just recently funded an ERASMUS+ project (CONSCIOUS: Curriculum Development of Human Clinical Trials for the Next Generation Biomedical Students). This consortium is led by Hungary in collaboration with France, Ireland, Czech Republic and Portugal and is intended to tackle skill gaps and mismatches related to European-level clinical trial professionals [23].

More exchange between National Scientific Networks of ECRIN member and observer countries may inspire their national plans, projects and negotiations. The information may furthermore serve as a benchmark to position, scrutinise and further develop their own organisation. The national view may be challenged and enriched by the broader European picture. And last but not least, access to information, documents and expertise should lead to a mutual benefit for all members, avoiding duplication of efforts and a waste of taxpayer money. Showing and promoting the impact and (untapped) potential of a network of networks may help to support the continuation of national funding. ECRIN and the scientific partners may also support the European Union (respectively the responsible taskforces) in continuously harmonising training once the Clinical Trial Regulation (EU number 536/2014) enters into force.

Curricula for clinical research functions/determination of core competencies for specific functions (e.g. for universal functions like (principal) investigator or study nurse) and a European-wide agreement on curricula and core competencies could be an aim. As a starting point, the exchange of available curricula and sets of core competencies could improve professionalism.

Training offered by ECRIN should be distinguished between “internal training” (for the CTUs and networks) and “external training” (e.g. for clients like investigators). Whereas the latter may preferably be offered at the national or even local level (may be supported by central offers for multinational, European or international aspects), internal training at the European level could be of high value.

The national networks are increasingly creating and offering jobs for highly qualified staff. Furthermore, academic career paths are starting to be offered more systematically and are officially recognised, resulting in titles (e.g. PhD in clinical research). This will lead to more professionalism in clinical research and will attract more young talents. ECRIN may map and monitor this development and facilitate staff exchanges between national networks.

There are some limitations of the survey. Data collection has been restricted to 11 member and observer countries of ECRIN and the coordinating units of the National Scientific Networks. The ECRIN partners served as a convenient and representative sample. However, we cannot exclude other training initiatives not known to the network. As a consequence, the information may not be complete in all cases and may not be representative for the European Union. In addition, heterogeneity in the use of clinical research terms was identified in the survey. As an example, different countries have a different understanding of the profile of a study coordinator. For some countries this means “coordinating investigator”, for others it means rather a project manager function or is a synonym for study nurse. Defining the different profiles in advance may help to get a more consistent result in the future. The same is true for academic titles and degrees (PhD, master, etc.) versus career options (CRA, data manager, etc.). Nevertheless, the survey has been performed in three rounds with stepwise improvement of the information and face to face discussions between the survey participants and thus gives a good overview of the training activities in the participating countries (see Additional file 2).

There is a substantial and impressive investment in training and education of clinical research in the individual ECRIN countries. But so far, a systematic approach for (top-down) strategic and overarching considerations and cross-network exchange is missing. Exchange of available curricula and sets of core competencies between countries could be a starting point for improving the situation.