anz clinical trials - what is the future? session chair: michael quinn

ANZ Clinical Trials - What is the Future?

Session Chair:

Michael Quinn

Some basic observations•We need to have clinical trials as part of

undergraduate education•All doctors need more training about clinical trials.•There is a need for properly-trained patient

advocates.•Other major patient issues include access to trials

(age and ethnicity) and travel costs.

Participation

• Less than 5 per cent of patients take part in oncology trials in the US, 5 – 6 per cent in mainland Europe and 11 per cent in the UK.

•We need to agree on a minimum patient accrual rate per cancer unit/centre in Australia...percentage or hard numbers

• If cancer centres were to be accredited, then accrual into clinical trials could be a part of that accreditation..RANZCOG?

Other jurisdictions….

Recommendation:

•Each country should have a single national ethical approval process, with local ethics committees to supervise the performance of trials.

• It was suggested that one possible model for this is the French approach with the submission to the Competent Regional Ethics Committee (CPP) of the national coordinating investigator. The advice of this CPP is valid for all French sites.

Recommendation:

•The monitoring and reporting requirements of academic clinical trials should be the same as for commercial trials

Recommendation:

•Currently, there are different ethical guidelines for clinical research and genetic research. These need to be combined, to underpin the development of personalised medicine. It should be possible to use donated tissues for future academic research project approved by Ethics Committee e.g. the one of institution hosting the researcher without having to re- consent the donor.

•9 July 2012•FP7: the future of European Union research policy•As part of a €10.8 billion budget for research and

innovation agreed for 2013, the European Commission has announced an €8.1 billion euro package of calls for proposals under the EU’s Seventh Framework Programme for Research (FP7). This is the final and largest ever package of FP7 calls, and is an important part of the Commission’s commitment to work for growth and jobs in Europe.

• Making Europe a destination for world-class researchers is another key priority. The European Research Council will invest over €1.7 billion in the best researchers and additional €963 million will support mobility through “Marie Curie Actions”.

Facts & figures

• Marie Skłodowska-Curie Actions (MCA) contribute towards a strong, high-quality research landscape in Europe by fostering the international and cross-sectoral mobility of researchers, offering attractive employment and training opportunities, promoting professional standards in research careers and equipping researchers with the skills needed in the modern economy. 40% of the MCA budget is allocated to the training of early-stage researchers.

• Under FP7, by 2013, the programme expects to have supported 50,000 researchers and funded 10,000 PhDs.

SPEAKERS

•Michael Friedlander•Peter Sykes•Henry Kitchener•Dan Thurley•Clive Morris