1. Clinical trials in Europe Emma Greenwood, Policy Manager Thursday 23 rd February

2. About Cancer Research UK  Cancer Research UK is the largest non-public funder of cancer research in Europe  Europe’s largest fundraising charity  Last year we invested £332 million in research  Currently fund 241 trials of which over 55 involve international collaboration with institutions in EU member states  Participate in, and help fund, numerous international projects including the International Cancer Genome Consortium (ICGC), European Prospective Investigation into Cancer (EPIC), International Cancer Benchmarking Partnership (ICBP)  Recently launched the International Rare Cancers Initiative 2

3. Cancer trials in the UK: A success story NIHR Clinical Research Networks have improved the conduct and delivery of research In 2010/11 the equivalent of 19.8% of new incident cancer cases were recruited into an NCRN supported study. 61% of these cancer patients (32,000 per year) are enrolled into a Cancer Research UK supported study – these studies have changed clinical practice in many years.

4. Benefits of patient involvement in trials Gain early access to innovative medicines, devices, procedures of diagnostic techniques Increased monitoring Access to leading-research active experts One-to-one care from experienced research nurses Improved information Better continuity of care

5. Improving patient care I have been on two clinical trials. The first one was a 14 month vaccine offered when my current treatment was beginning to fail. When this trial ended I took part in a second trial, which produced side effects. However, it was worth all the discomfort to progress treatment and, eventually, get some personal benefit and I would do it all again and am currently waiting for another suitable trial to become available. Clinical trials are essential to developing future treatments and I would not be here now if others had not co-operated in the past. Nigel Lewis-Baker 3

6. before after Impact of the Clinical Trials Directive 4

7. Revising the Directive Retain the function of national competent authorities in regulating single country trials with multinational trials having the option to participate in a Co-ordinated Assessment Procedure (CAP) The definition of an Investigational Medicinal Product should be limited to include only therapies which are genuinely investigational and novel The Directive should allow for a risk-based approach to the assessment of clinical trials, ideally with the onus on the Sponsor to justify the assessment Substantial amendments should be limited to changes that affect patient safety or the scientific outcome of a trial, as opposed to reporting purely administrative amendments The safety reporting system should be overhauled so that SUSARs are reported in a manner which directly contributes to patient safety Multiple organisations should be allowed to sponsor clinical trials in order for risk and responsibility to be shared and facilitate further collaborative working 5