60% increase in commercial study throughput to date in year 2012-2013 40% increase in number of companies NCRN working with (171 in total) 132 open studies 98 in set up
Recruitment to target 2012/13 55 studies closed, 4 terminated 35 (69%) have recruited to 100% of target 35 (69%) have recruited to 100% of target 39(76%) have recruited to least 90% of target 39(76%) have recruited to least 90% of target
Portfolio by CSG increases in new portfolio studies by year 2011/12 – 2012/13 Prostate – 400% (2 vs 16 studies) Melanoma – 100% (5 vs 10 studies) Lymphoma - 60% (1 vs 16 studies) Haem Onc – 43% (15 vs 23 studies) Breast - 40% (12 vs 17 studies) Lung/ Upper GI – 30% (9 vs 12 studies)
Industry Studies as a % of CSG Portfolio Overall industry studies account for 33% of the NCRN portfolio
Supporting research to make patients, and the NHS, better Service Improvement Programme: Eligibility and Feasibility Project for Commercial studies
Problems and Aims of the SIP Project Problems Very resource/labour intensive Variability across Networks Poor perception of process by Industry Aims Reduce internal time taken in management of feasibility & adoption process Have a process that adds value to Industry Increase in volume & delivery of commercial trials
Key changes Customer Interface Upfront triage - Centralised triage using tools so that customer interface is professional and consistent to all customer types. Managing expectations - Service agreements, timelines for services and information requirements (inc eligibility criteria) set upfront. Company feasibility information can be used and should be shared Network knowledge of site capability and performance to be made available. Portfolio Eligibility Change in eligibility criteria Split between eligibility and feasibility assessment- upfront portfolio eligibility decision to be made quickly Studies deemed eligible only rejected if not feasible Adoption term no will no longer be relevant Reduction in timelines for portfolio eligibility decision and feasibility
Key changes Clinical (CSG) Review Clinical Review still an important part of the process but can be tailored to the service offering Formal panels adoption no longer required for all studies routinely Clinical review can be part of the site intelligence and validation of pre- selected sites (with PIs & LRN mgrs) or via escalation to a clinical expert at any part of the process. Feasibility –Shifting emphasis away from expert review of overall feasibility to greater reliance on robust local feasibility –Potential to escalate difficult studies for feasibility panel review Agreement Targets Site targets are mutually agreed by network and customer prior to study being on the portfolio, data in making decisions is shared as part of the discussion.
New Commercial Eligibility Criteria 1. Does the study have a research question? definition to be the same as that for the non commercial portfolio. Excludes audit, needs assessment, quality improvement, local service evaluations almost all else would fulfil definition 2. Has it undergone adequate review? companies can self assess clinical peer review NHS REC approval and NHS permissions pre requisites for research to be supported No longer assessment of valid research question or patient benefit as part of the eligibility process: this is now accepted to be part of the local feasibility process.
NCRN Challenges Portfolio and performance management will be more difficult Accepting all studies may reduce positive trends in delivery to time and target. Positive aspects of NCRN badging likely to be lost Competition for resources on the ground if all commercial studies enter the portfolio Clinical review is a fundamental part of NCRN feasibility process and has helped sense check targets, assess patient benefit and highlight potential conflicts / issues – aim to keep this value add and ability to identify difficult studies Continuing engagement of CSG members Big reliance on local feasibility which has not proved reliable in the past
Discussion points for CLG Group Input into early feedback service Development of CLG industry panel Explore patient perspectives on biosimilars