Well trained investigators and support staff are key to the success of clinical trials, whether commercially or non-commercially sponsored. To support the training of staff involved in the conduct and oversight of clinical trials, NHMRC, in conjunction with Australian Clinical Trials Alliance (ACTA) has developed core competencies for Australian Academic Clinical Trialists (the Competencies).
The Competencies are intended to be used in the development of detailed curricula and training courses by universities, Colleges and other registered training organisations. The intended audience for the Competencies includes undergraduate and post-graduate students as well as individuals undertaking on-the-job training or continuing professional development.
The Competencies recognise distinctions between commercially-sponsored and non-commercially sponsored clinical trials; however they are not exclusively intended for ‘academic’ clinical trialists. Rather, courses developed on the basis of the competencies should equip students and individuals with the knowledge and skills appropriate for their role on a clinical trial and the nature of the trial. The degree to which courses (or individual modules) focus on matters specific to, for example, a non-commercial, comparative study or a non-drug trial will be a matter for training providers, having regard to the Competencies as a whole.
The Competencies are based on a pre-existing framework developed for commercially-sponsored studies by the Clinical Trials Transformation Initiative and Transcelerate Biopharma and align with other international work in this space.
Please note: the term ‘principal investigator’ referenced in the document may be a single individual, however, when applied to an academic clinical trials context it can be a team of researchers working alongside a project manager.
In August 2015, NHMRC and ACTA held a roundtable to commence the development of draft competencies.
The broad aims of the roundtable were to:
• Discuss and develop an agreed set of core competencies to ensure that academic clinical trialists can demonstrate that they have the skills and knowledge required to conduct safe and high-quality clinical trials.
• Discuss a framework for training objectives that could be used to meet these competencies and pathways/opportunities to support such a training framework in Australia.
• NHMRC initiatives and role in education and training - Dr McGurk (PDF 3.5MB)
• OECD Core Competencies for Clinical Trials - Prof Ghersi (PDF 483KB)
• Vocational Education and Training (VET) - Ms Akister & Ms Mepham (PDF 306KB)
• Minutes from Core Competencies Roundtable (PDF 47KB)
Further educational material on clinical trials can be found on www.AustralianClinicalTrials.gov.au