Grant for competence programme in clinical therapy research

Framework for the competence program

To receive funding from the Swedish Research Council, the national competency programme must meet the following general requirements.

The competence programme shall

• be affiliated with a Swedish higher education institution (university or university college) or a region with primary coordination responsibility

• be conducted by at least 3 Swedish higher education institutions and/or regions in collaboration (one main applicant and at least two co-applicants)

• have a clear organisation and management, responsible for quality assurance of the curriculum, in collaboration between the partnering organisations

• have a main focus on planning, conducting and reporting randomised clinical trials, but complementary modules on other types of clinical studies may be included

• have a structured, cohesive curriculum with common courses and seminars of high scientific and pedagogical quality that should be nationally accessible
• contain an educational plan based on an annual program where the program can be funded for up to 3 years, i.e. 3 cohorts of participants

• be aimed at programme participants who are PhD-qualified researchers employed within a region and/or higher education institution in Sweden

• examine the participants, who are also expected to become certified in Good Clinical Practice (GCP according to ICH).

Focus

The purpose of the programme is to strengthen the competence of researchers with a PhD who wish to conduct randomised clinical trials and can be applied for by an organisation (a Swedish HEI or a Swedish region). The program should have a national scope and offer education relevant to researchers with a PhD from across Sweden who are employed within a region or at an academic institution. The goal is to disseminate and enhance knowledge on how to conduct high‑quality randomised clinical trials, for example regarding regulations and permit applications, public involvement, statistical analysis, patient recruitment, project management, and Good Clinical Practice (GCP).

Participants in the programme shall be PhD-qualified researchers who, after completing the programme, will be well acquainted with all aspects of planning, conducting and reporting randomised clinical studies and clinical trials. This also includes all components of permit applications, as well as applications for funding of clinical studies in treatment research, and the support resources available regionally and nationally to carry out randomised clinical studies and trials.

The competency programme is expected to encourage more researchers to successfully plan, develop study designs and conduct randomised clinical studies and trials, both academically initiated and in collaboration with industry.