1	CCRG Cornwall Clinical Research Group Who we are and where we are Track Record Expertise The patient Ethics Staff and training Feasibility Budget The Future
2	CCRG: WHO and WHERE CCRG is a group (n=12) of commercially aware, research-orientated general practitioners formed and active over the last 15 years with extensive phase II – IV clinical trial experience in most therapeutic areas. Based in Cornwall & Plymouth. Range of sites within city and rural environments. Total available patient population of 100,000 in areas of stable domicile.
3	CCRG: TRACK RECORD CCRG have performed a large number of studies in a wide variety of therapeutic areas. Examples from the previous 5 years:
4	CCRG: TRACK RECORD
5	CCRG: EXPERTISE Pride ourselves in recruiting target number of patients well within agreed time lines. Expertise in rescuing failing studies from other groups (primary care, secondary care and SMOs) typical recruitment/target = 142 - 149% Function as a co-operative to ensure that if any CCRG investigator falters with recruitment, any slack can be easily taken up by others within the group. Based on excellent intra - CCRG communication and personal support. This co-operative nature gives additional confidence when predicting patient numbers.
6	CCRG: THE PATIENT Each CCRG investigator is in possession of the full medical history of each research patient. Patients are not referred to third parties for assessment. Advantages include: relationship & trust between patient and investigator informal screening especially for opportunistic studies during morning, afternoon and evening surgeries, five days/week formal screening from practice computers retention in study (low drop-out rates): patients can be reassured Low ‘screen failure’ rate (typically 6-10%) safety (knows patients’ previous Hx and Rx) and safety updates can be quickly generated in context assessment at home if necessary each patient has 24h mobile contact number of investigator.
7	CCRG: STAFF and TRAINING All practices have full-time/part-time research nurses and some have dedicated study site co-ordinators. All ICH-GCP trained. Most sites have a partner who acts as a co-investigator. Important that trials can proceed during investigators’ holiday absences. Ongoing mentoring system to ensure that any new investigator is ‘up-to-speed’ as quickly as possible. Previous experience with EDC and diary-based PDA applications and a willingness to embrace new technology.
8	CCRG: ETHICS Have investigators who currently serve on MRECs and LRECs and thus have ethics committee expertise. Group members experienced and willing to make MREC and LREC submissions and to co-ordinate these activities with the Sponsor. Encompasses only one strategic health authority area. If Plymouth approve a study then it is automatically approved by the Cornwall Committee and vice versa
9	CCRG: ADVICE & FEASIBILITY TESTING Willing to perform protocol and site-specific feasibility. Track record of advising on protocols to ensure that the correct patient population is utilised. Many studies conceived as ‘secondary care’ are in fact much easier to recruit in the primary care environment and with the wealth of CCRG’s phase II expertise, safety monitoring is second nature
10	CCRG: BUDGET Competitive costings can be completed during feasibility and calculated on the basis of: - medical time - research nurse time (medical time not costed for research nurse time!) - administration (data queries/site visits) - no overhead or institutional charges - willing to invoice according to company’s budget schedule Close geographical nature of sites allows for a number of monitoring visits to be undertaken on consecutive days to avoid excessive and expensive travel. Monitoring visits can be co-ordinated by a central co-ordinator to ensure that all proposed monitoring visits are scheduled as efficiently as possible. Investigators are aware of the time needed by monitors for F-2-F discussions with investigators and other members of the research team. All sites within range of ‘budget airline’
11	CCRG: THE FUTURE Low screen failure rate and able to provide numbers of potential patients during detailed feasibility testing and initiation visits. Detailed risk analysis and contingency planning by CCRG at the outset of each trial. Development of web-based patient tracking system so that Sponsor and CCRG members aware of day-to-day recruitment and number of patients individual GPs have to screen to meet their recruitment targets. Initially developed to ensure group aware on a day-by-day basis of their targets. Sponsors may have access to this during the trial. We know that the Pharma business changes rapidly. And we feel that we are equipped to respond and adapt to those changes by embracing new technologies.