Y2 Performance Report

Transcription

1 Canadian Cancer Clinical Trials Network Y Performance Report April, 05 March 3, 06 Report Created: June 8, 06

2 Table of Contents Section A: Progress at Adult Network Sites... Section B: Progress at Pediatric Network Sites... 0 Appendix: Additional Notes... 8 Legend: below quarter baseline exceed quarter baseline 3CTN Performance Report, created: April 9, 06 Recruitment database lock date: May 3, 06

3 Section A: Progress at Adult Network Sites Objective: To improve patient access to academic clinical trials: a) Improve adult patient recruitment by greater than 50% within four years Figure. Number of Patients Recruited to Adult Portfolio Trials, Q3 04/5 - Q4 05/6 05/6 Quarterly Network Target Q Q Q Q Q Q Notes: 48 patients were recruited to adult Portfolio trials in 05/6. The annual Network target for 05/6 is 686 patients (about 5% over baseline). The Network is 0% below its annual network target but 3% below if calculating based on cumulative contract targets. Data includes adult sites with formal Agreements with 3CTN (N=48). The Network target is the target recruitment per year, as defined in the 3CTN business plan. The site target is the target recruitment per year as defined in the Agreement between 3CTN and sites. Only Qs accrual from Quebec sites and Mount Sinai Hospital; Q from St Joseph Hamilton, % to prorated baseline for these sites. 05/6 progress against quarterly 05/6 Network Target Actual Target Difference Y Baseline Accrual % above baseline 05% 5% 00% 3CTN Performance Report, created: April 9, 06 Recruitment database lock date: May 3, 06

4 M B Atlanti c AB BC Quebec* ON Figure. Number of patients recruited to adult Network sites per region in 05/6 British Columbia Alberta Manitoba Manitoba Atlantic Canada Alberta Quebec* British Columbia Ontario Annual Baseline Y Actual Figure 3. Number of patients recruited to adult Network sites per local-regional node (NCC + NACC) in 05/6 TOH PM SRI JCC LRCP MUHC CHUQ CHUM VC CCI TBCC SJRH NSHA CCMB CTN Performance Report, created: April 9, 06 Recruitment database lock date: May 3, 06 3

5 M B Atlanti c AB BC Quebec* ON Figure 4. Progress to recruitment baseline at adult Network sites per region in 05/6 Ontario British Columbia Quebec* Alberta Atlantic Canada Manitoba 58% 73% 76% 3% 9% 40% 0% 0% 40% 60% 80% 00% 0% 40% 60% Figure 3. Number of patients recruited to adult Network sites per local-regional node (NCC + NACC) in 05/6 TOH PM SRI JCC LRCP MUHC CHUQ CHUM VC CCI TBCC SJRH NSHA CCMB CTN Performance Report, created: April 9, 06 Recruitment database lock date: May 3, 06 4

6 Table. Number of patients recruited per adult Network site Network Site **Baseline Year Target Q 05 Q 05 Q3 05 Q4 05 Total % of baseline % of Target London Regional Cancer Program Grand River Regional Cancer Centre Windsor Regional Hospital Juravinski Cancer Centre Niagara Health System Cambridge Memorial Hospital St.Joseph Healthcare Hamilton* Sunnybrook Research Institute North York General Hospital NA 400 Toronto East General Hospital Humber River Hospital NA 00 Princess Margaret Cancer Centre Northeast Cancer Centre - Health Sciences North Trillium Health Partners Thunder Bay Regional Health Sciences Centre Southlake Regional Health Centre Royal Victoria Hospital St. Michael's Hospital William Osler Health System Markham Stouffville Hospital NA 0 Mount Sinai Hospital* The Ottawa Hospital Kingston General Hospital Lakeridge Health CancerCare Manitoba Saint John Regional Hospital Dr. Everett Chalmers Hospital The Moncton Hospital**** Dr. Léon-Richard Oncology Centre Nova Scotia Health Authority Cape Breton Cancer Centre***** PEI Cancer Treatment Centre Nova Scotia Health Authority, Hematology Vancouver Centre Abbotsford Centre Centre for the North Sindi Ahluwalia Hawkins Centre for the Southern Interior Fraser Valley Centre**** Vancouver Island Centre CTN Performance Report, created: April 9, 06 Recruitment database lock date: May 3, 06 5

7 Network Site **Baseline Year Target Q 05 Q 05 Q3 05 Q4 05 Y Total % of baseline % of Target McGill University Health Centre (MUHC)*** CIUSSS de l Ouest-de-l Île-de-Montréal(CIUSSS ODIM)* CIUSSS du Centre-Ouest-de-l Île-de-Montréal(CIUSSS CODIM)* CISSS de l'outaouais* CHU de Québec Université Laval* CISSS du Bas-Saint-Laurent(CISSS-BSL)* Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)*** CIUSSS de l Estrie Centre hospitalier universitaire de Sherbrooke (CIUSSS-Estrie-CHUS)* CISSS de Chaudière-Appalaches(CISSS CA)*** Centre Hospitalier de l Université de Montréal (CHUM)* CIUSSS de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ) * CISSS de Laval* CIUSSS du Nord-de-l Île-de-Montréal(CIUSSS NDIM)* CIUSSS de l Est-de-l Île-de-Montréal(CIUSSS-EDIM)* Tom Baker Cancer Centre Cross Cancer Institute Adult Patients (N=48) Total Network Site **Y Baseline **Y Baseline Year Target Q3 04 Q4 05 % of Y baseline Q 05 Q 05 Q3 05 Q4 05 Y Total % of Y baseline % of Y Target Total (N=65 in Y all reporting sites only, N= sits for Y) Adult Patients (N=48 Total for Y, and 36 for Y) Ped sites (N=7) total Total # of sites met baseline or target in Y Total # of sites met baseline or target in Y 3 Note: * Not had full year reports, baseline and target numbers were prorated based on the number of quarters they reported 0-49 **The baseline is the average number of patients recruited to the 3CTN portfolio from Y is prorated to 0.5 annual baseline as it started Oct *** No reports available ****Future potential NACC Year overall target is 5% over the baseline, but some sites have less than 5% target in their contracts. The additional sites have % growth target CTN Performance Report, created: April 9, 06 Recruitment database lock date: May 3, 06 6

8 # of trials Objective: To demonstrate impact of the Network and academic trials on the Canadian Health Care System: a) Develop and maintain a portfolio of academic trials that will ensure the enthusiastic participation of academic trialists and patients and impact patient care Figure 6. Total Portfolio Trials Year over Year for Adult Network Sites (0-05) Notes: These trials are reported based on fiscal year April 0- March 06. There were 79 Portfolio trials for adult network sites. Two available at both adult and pediatric Network sites in 05 and is included in both adult and pediatric figures The data provided in Figure 7 are a snapshot of the Portfolio as of June 8, 06 (N=79) Fiscal Year 0 Fiscal Year 0 Fiscal Year 03 Fiscal Year 04 Fiscal Year 05 Overlap Adults CTN Performance Report, created: April 9, 06 Recruitment database lock date: May 3, 06 7

9 Figure 7. Breakdown of Fiscal Year 05 Portfolio trials at adult Network sites Skin / Melanoma Sarcoma Other Lung 6 6 Hematology Head and neck 4 Gynecological 5 5 Genito-Urinary Gastrointestinal Breast Brain/CNS Not Applicable Phase I Phase I/II Phase II Phase II/III Phase III Phase IV Pilot/Feasibility 3CTN Performance Report, created: April 9, 06 Recruitment database lock date: May 3, 06 8

10 Figure 8. Breakdown of personalized medicine trials at adult Network sites for 05/06 Portforlio Trials Patient eligibility, 4, 3% Stratify into different groups,, % Notes: Personalized medicine trials open to recruitment at adult Network sites, as of December 3, 05 (n=79) 4% of all trials at adult Network sites have a personalized medicine component Two trials were available at both adult and pediatric Network sites in 05 and are included in both adult and pediatric figures Molecular targeted therapy, 5, 4% Study endpoint or objective, 6, 4% No personalized medicine component, 03, 58% Category Patient eligibility Study endpoint Stratify into different groups Targeted therapy Definition Use of a genetic marker or other individualized biologic factor to determine if patient is eligible for the trial (i.e. included in trial design via the inclusion/exclusion criteria) Use of a genetic marker or other individualized biologic factor to correlate with study endpoint (i.e. included in trial design as an objective or endpoint) After patient enrollment, trial design uses a genetic marker or other individualized biologic factor to stratify into different groups (i.e. included in trial design to stratify for treatment or analysis groups) Trial is using a molecular targeted therapy; drug used in a targeted patient population ( i.e. HER+ breast cancer gets a HER targeted agent) 3CTN Performance Report, created: April 9, 06 Recruitment database lock date: May 3, 06 9

11 Figure 9. Breakdown of Portfolio trials at adult Network centres by lead country for 05/06 Porforlio Trials Other,, 6% Notes: Breakdown of trials at adult Network sites by lead country, as of June 8, 06 (n=79) Approx. 60% of all trials at adult Network sites are led by Canada 8% of which are international, multicentered studies The average number of Network sites per trial led by Canada (including international multicentered) is 5. Two trials were available at both adult and pediatric Network sites in 06 and are included in both adult and pediatric figures. United States, 60, 34% Canada, 94, 5% Canada - International, 4, 8% 3CTN Performance Report, created: April 9, 06 Recruitment database lock date: May 3, 06 0

12 Section B: Progress at Pediatric Network Sites Objective: To improve patient access to academic clinical trials: Improve recruitment of pediatric patients Figure 0. Number of patients recruited to Portfolio trials at pediatric Network sites Q3 04/5 - Q4 05/ Quarterly Target 9 08 Notes: 363 patients were recruited to Portfolio trials at pediatric Network sites in 05/6. The annual target is 44 patients. Pediatric Network sites are 4% below its quarterly target for recruitment Data include pediatric sites associated with the C7 Council (n=7) Q Q Q 05-6 Q 05-6 Q Q /6 progress against Y target Accrual Target Difference Accrual % above baseline 99% 0% 3CTN Performance Report, created: April 9, 06 Recruitment database lock date: May 3, 06

13 CHU de Sherbrooke Kingston General Hospital Saskatoon Cancer Centre CHU de Quebec Stollery Children s Hospital Children s Hospital of Eastern Ontario Alberta Children s Hospital BC Children s Hospital The Hospital for Sick Children Figure. Number of paitents recruited per pediatric Network site in 05/ CHU de Sherbrooke Allan Blair Cancer Centre Kingston General Hospital Janeway Child Health Centre Saskatoon Cancer Centre CancerCare Manitoba CHU de Quebec IWK Health Centre Stollery Children s Hospital Children s Hospital, London Health Sciences Centre Children s Hospital of Eastern Ontario McMaster/Hamilton Health Sciences Centre Alberta Children s Hospital Montreal Children s Hospital BC Children s Hospital CHU Sainte-Justine The Hospital for Sick Children Figure. Progress to baseline recruitment per pediatric Network site in 05/6 0% 0% 6% 78% 75% 8% 9% 90% 95% 96% 00% 00% 05% % 5% 8% 43% 0% 0% 40% 60% 80% 00% 0% 40% 60% 3CTN Performance Report, created: April 9, 06 Recruitment database lock date: May 3, 06

14 Table. Number of patients recruited per pediatric Network site Network Site Annual Q3 Q4 Q Q Q3 Q4 YTD Baseline The Hospital for Sick Children CHU Sainte-Justine BC Children s Hospital Montreal Children s Hospital Alberta Children s Hospital McMaster/Hamilton Health Sciences Centre Children s Hospital of Eastern Ontario Children s Hospital, London Health Sciences Centre Stollery Children s Hospital IWK Health Centre CHU de Quebec CancerCare Manitoba Saskatoon Cancer Centre Janeway Child Health Centre Kingston General Hospital Allan Blair Cancer Centre CHU de Sherbrooke C7 Total Y Actual vs. Baseline 3CTN Performance Report, created: April 9, 06 Recruitment database lock date: May 3, 06 3

15 # of trials Objective: To demonstrate impact of the Network and academic trials on the Canadian Health Care System: a) Develop and maintain a portfolio of academic trials that will ensure the enthusiastic participation of academic trialists and patients and impact patient care Figure 3. Total Portfolio Trials Year over Year for Pediatric Network Sites (0-05) Notes: There were 44 Portfolio trials available at pediatric Network sites, new trials added at the end of Quarter 4 The data provided in Figure 3 is a snapshot of the Portfolio as of June 8, 06 Two trials were available at both adult and pediatric Network sites in 05 and are included in both adult and pediatric figures Fiscal Year 0 Fiscal Year 0 Fiscal Year 03 Fiscal Year 04 Fiscal Year 05 Overlap Peds CTN Performance Report, created: April 9, 06 Recruitment database lock date: May 3, 06 4

16 Figure 4. Breakdown of Fiscal Year 05 Portfolio trials at pediatric Network sites Sarcoma Other 3 Hematology 4 Genito-Urinary Gastrointestinal Brain/CNS 5 5 Bone Phase I Phase I/II Phase II Phase II/III Phase III Phase IV Not Applicable 3CTN Performance Report, created: April 9, 06 Recruitment database lock date: May 3, 06 5

17 Figure 5. Breakdown of personalized medicine trials at pediatric Network sites in fiscal year 05/06 Stratify into different groups,, 4% Molecular targeted therapy, 6, 4% Study endpoint, 6, 4% No personalized medicine component, 3, 5% Notes: Personalized medicine trials at pediatric Network sites, as of June 8, 06 (n=44) 48% of all trials at pediatric Network sites have a personalized medicine component Two trials were available at both adult and pediatric Network sites in 05 and are included in both adult and pediatric figures Patient eligibility, 7, 6% Category Patient eligibility Study endpoint Stratify into different groups Targeted therapy Definition Use of a genetic marker or other individualized biologic factor to determine if patient is eligible for the trial (i.e. included in trial design via the inclusion/exclusion criteria) Use of a genetic marker or other individualized biologic factor to correlate with study endpoint (i.e. included in trial design as an objective or endpoint) After patient enrollment, trial design uses a genetic marker or other individualized biologic factor to stratify into different groups (i.e. included in trial design to stratify for treatment or analysis groups) Trial is using a molecular targeted therapy; drug used in a targeted patient population ( i.e. HER+ breast cancer gets a HER targeted agent) 3CTN Performance Report, created: April 9, 06 Recruitment database lock date: May 3, 06 6

18 Figure 6. Breakdown of Portfolio trials at pediatric Network centres by lead country in 05/06 Other,, 4% Canada, 6, 4% Canada - International,, % Notes: Breakdown of trials at pediatric Network sites by lead country, as of June 8, 06 (n=44) 6% of all trials at pediatric Network sites are led by Canada % of which are international, multicentered studies The average number of Network sites per trial led by Canada (including international multicentered) is 8. Two trials were available at both adult and pediatric Network sites in 05 and are included in both adult and pediatric figures United States, 35, 80% 3CTN Performance Report, created: April 9, 06 Recruitment database lock date: May 3, 06 7

19 Calendar Year # Portfolio application average application processing time* Calendar Year # Portfolio application average peer review processing time** *from application received to approve/decline the application since Jan 3, 05 to May 3, 06 ** from date site agreed to pursue peer review to date last reviewer submitted completed PR package to 3CTN Appendix: Additional Notes Table 3. Reporting periods and dates Q4 04/5 Q4 05/6 Quarter Period Recruitment Database Lock Q3 04/5 October December 04 NA* Q4 04/5 January March 05 NA* Q 05/6 April June 05 NA* Q 05/6 July September 05 October 0, 05 Q3 05/6 October December 05 March 3, 06 Q4 05/6 January March 06 May 3, 06 *Dates not available as database lock implemented in Q 05/6 3CTN Performance Report, created: April 9, 06 Recruitment database lock date: May 3, 06 8