Y3 Performance Report

Transcription

1 Canadian Cancer Clinical Trials Network Y3 Performance Report April, 06 March 3, 07 Report Created: June 8, 07

2 Table of Contents Section A: Progress at Adult Network Sites... Section B: Progress at Pediatric Network Sites... Section C: Portfolio Efficiency... 0 Section D: Other metrics... 0 Appendix: Additional Notes... 3 Legend: below quarter baseline exceed quarter baseline 3CTN Performance Report, created: June 5, 07 Recruitment database lock date: May 3, 07

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 Q Figure. Number of Patients Recruited to Adult Portfolio Trials, Q3 04/5 - Q4 06/7 Q Actual accrual Quarterly Target Number of sites Q 05-6 Q 05-6 Q Q Q 06-7 Q 06-7 Q Q Notes: 3798 patients were recruited to adult Portfolio trials in 06/7. The annual Network target for 06/7 is 546 patients (about 37.5% over baseline). The Network is 8% above its annual network target if calculating based on cumulative contract targets. Data includes adult sites with formal Agreements with 3CTN (N=49). 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. 06/7 progress against quarterly 06/7 Network Target Actual Target Difference Y3 Baseline Accrual % above baseline 55% 38% 00% 3CTN Performance Report, created: June 5, 07 Recruitment database lock date: May 3, 07

4 M B Atlantic AB BC Quebec* ON Figure. Number of patients recruited to adult Network sites per region in 06/7 Ontario British Columbia Quebec* Alberta Atlantic Canada Manitoba Manitoba Atlantic Canada Alberta Quebec* British Columbia Ontario Annual Baseline Y3 Actual Figure 3. Number of patients recruited to adult Network sites per local-regional node (NCC + NACC) in 06/7 TOH PM SRI JCC LRCP MUHC CHUQ CHUM VC CCI TBCC SJRH NFL NSHA CCMB CTN Performance Report, created: June 5, 07 Recruitment database lock date: May 3, 07 3

5 MB Atlantic AB BC QC ON Nati onal Figure 4. Progress to recruitment baseline at adult Network sites per region in 06/7 Ontario 88% British Columbia 4% Quebec* 07% Alberta 46% Atlantic Canada 95% Manitoba 03% 0% 0% 40% 60% 80% 00% 0% 40% 60% 80% 00% Figure 5. Percentage of patients recruited to baseline of adult Network sites per local-regional node (NCC + NACC) in 06/7 C7 TOH PM SRI JCC LRCP MUHC CHUQ CHUM VC CCI TBCC SJRH NSHA CCMB 64% 90% 93% 00% 03% 39% 30% 6% 4% 34% 64% 6% 0% 50% 00% 50% 00% 50% 300% 350% 73% 86% 30% 3CTN Performance Report, created: June 5, 07 Recruitment database lock date: May 3, 07 4

6 Table. Number of patients recruited per adult Network site (by fiscal year) Network Site (by fiscal year) **Y3 Baseline Y Total % of Y baseline Y Total % of Y baseline Q 06 Q 06 Q3 06 Q4 06 Y3 YTD Total 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 0 3 NA 4 NA 4 8 Toronto East General Hospital Humber River Hospital 0 0 NA NA 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 0 0 NA 0 NA Mount Sinai Hospital* The Ottawa Hospital Kingston General Hospital Lakeridge Health CancerCare Manitoba CTN Performance Report, created: June 5, 07 Recruitment database lock date: May 3, 07 5

7 Network Site **Y3 Baseline Y Total % of Y baseline Y Total % of Y baseline Q 06 Q 06 Q3 06 Q4 06 Y3 YTD Total % of Y3 baseline Saint John Regional Hospital % Dr. Everett Chalmers Hospital % Dr. Léon-Richard Oncology Centre % Nova Scotia Health Authority % PEI Cancer Treatment Centre % Nova Scotia Health Authority, Hematology % Eastern Regional Health Authority (NFL) % BC Cancer Agency - Vancouver Centre % Abbotsford Centre % Centre for the North, Prince George % Sindi Ahluwalia Hawkins Centre for the Southern Interior % Vancouver Island Centre % 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)* % CIUSSS de l Estrie Centre hospitalier universitaire de Sherbrooke (CIUSSS-Estrie- CHUS)* % 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)* % 3CTN Performance Report, created: June 5, 07 Recruitment database lock date: May 3, 07 6

8 Network Site **Y3 Baseline Y Total % of Y baseline Y Total % of Y baseline Q 06 Q 06 Q3 06 Q4 06 Y3 YTD Total % of Y3 baseline Tom Baker Cancer Centre % Cross Cancer Institute % Adult Patient Sites (N=49 for Y3, 48 for Y, % and 36 for Y) 864 Note: * Not had full year reports, baseline and target numbers were prorated based on the number of quarters they reported **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 04 *** 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. Updated June, 07 3CTN Performance Report, created: June 5, 07 Recruitment database lock date: May 3, 07 7

9 number of trial 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 Network Sites (0-07YTD) Notes: These trials are reported based on calendar year 0- June 07. There were 85 Portfolio trials for adult network sites in year 3. Four available at both adult and pediatric Network sites in 06 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, (YTD) Peds Adults CTN Performance Report, created: June 5, 07 Recruitment database lock date: May 3, 07 8

10 Figure 7. Breakdown of 06 Fiscal Year Portfolio trials at adult Network sites Skin / Melanoma 4 Sarcoma Other Lung 9 6 Hematology 8 Head and neck 4 Gynecological 5 5 Genito-Urinary Gastrointestinal Breast 6 8 Brain/CNS Not Applicable Phase I Phase I/II Phase II Phase II/III Phase III Phase IV Pilot/Feasibility 3CTN Performance Report, created: June 5, 07 Recruitment database lock date: May 3, 07 9

11 Figure 8. Breakdown of personalized medicine trials at adult Network sites for 06/07 Portforlio Trials Patient eligibility, 7, 5% Molecular targeted therapy, 6, 4% Study endpoint or objective, 3, % No personalized medicine component,, 59% Notes: Personalized medicine trials open to recruitment at adult Network sites, as of May 3, 07 (n=85) 49% of all trials at adult Network sites have a personalized medicine component; % of adult trials are immunotherapy related. Four trials were available at both adult and pediatric Network sites in fiscal year 3 and are included in both adult and pediatric figures 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: June 5, 07 Recruitment database lock date: May 3, 07 0

12 Figure 9. Breakdown of Portfolio trials at adult Network centres by lead country for 06/07 Portforlio Trials Other, 0, 5% Notes: Breakdown of trials at adult Network sites by lead country, as of May 3, 07 (n=85) Approx. 63% of all trials at adult Network sites are led by Canada 7% of which are international, multicentered studies The average number of Network sites per trial led by Canada (including international multicentered) is Four trials were available at both adult and pediatric Network sites in fiscal year 06 and are included in both adult and pediatric figures. United States, 54, 9% Canada only, 09, 59% Canada - International,, 7% 3CTN Performance Report, created: June 5, 07 Recruitment database lock date: May 3, 07

13 Section B: Progress at Pediatric Network Sites Objective: To improve patient access to academic clinical trials: Improve recruitment of pediatric patients Q Figure 0. Number of patients recruited to Portfolio trials at pediatric Network sites Q3 04/5 - Q4 06/7 76 Q Q 05-6 Actual accrual Q Q Quarterly Target Q Q Q Q Q Notes: 347 patients were recruited to Portfolio trials at pediatric Network sites in 06/7. The annual target is 45 patients. Pediatric Network sites are 30% below its quarterly target for recruitment Data include pediatric sites associated with the C7 Council (n=7) 06/7 progress against 06/7 Network Target Accrual Target Difference Annual baseline Accrual % above baseline 00% 30% 00% 3CTN Performance Report, created: June 5, 07 Recruitment database lock date: May 3, 07

14 Figure. Number of paitents recruited per pediatric Network site in 06/07 CHU de Sherbrooke Allan Blair Cancer Centre 0 0 Kingston General Hospital Janeway Child Health Centre Saskatoon Cancer Centre CancerCare Manitoba 4 CHU de Quebec 7 IWK Health Centre 6 Stollery Children s Hospital Children s Hospital, London Health Sciences Centre 6 6 Children s Hospital of Eastern Ontario 35 McMaster/Hamilton Health Sciences Centre 9 Alberta Children s Hospital 9 Montreal Children s Hospital 4 BC Children s Hospital CHU Sainte-Justine 39 4 The Hospital for Sick Children CTN Performance Report, created: June 5, 07 Recruitment database lock date: May 3, 07 3

15 Figure. Progress to baseline recruitment per pediatric Network site in 06/7 CHU de Sherbrooke Allan Blair Cancer Centre 0% 0% Kingston General Hospital 56% Janeway Child Health Centre 00% Saskatoon Cancer Centre CancerCare Manitoba 78% 83% CHU de Quebec 4% IWK Health Centre 80% Stollery Children s Hospital 36% Children s Hospital, London Health Sciences Centre 7% Children s Hospital of Eastern Ontario 75% McMaster/Hamilton Health Sciences Centre 36% Alberta Children s Hospital 43% Montreal Children s Hospital 58% BC Children s Hospital % CHU Sainte-Justine The Hospital for Sick Children 93% 96% 0% 50% 00% 50% 00% 50% 3CTN Performance Report, created: June 5, 07 Recruitment database lock date: May 3, 07 4

16 Table. Number of patients recruited per pediatric Network site (by fiscal year) Network Site **Y3 Baseline Y Total % of Y baseline Y Total % of Y baseline Q 06 Q 06 Q3 06 Q4 06 Y3 YTD Total % of Y3 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 0 0 NA 0 NA NA Ped sites (N=7) total % 3CTN Performance Report, created: June 5, 07 Recruitment database lock date: May 3, 07 5

17 number of trial 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 Network Sites (0-07YTD) Notes: There were 37 Portfolio trials available at pediatric Network sites, 6 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 06 and are included in both adult and pediatric figures (YTD) Peds Adults CTN Performance Report, created: June 5, 07 Recruitment database lock date: May 3, 07 6

18 Figure 4. Breakdown of Fiscal 06 Portfolio trials at pediatric Network sites Sarcoma Other 3 Hematology Genito-Urinary Gastrointestinal Brain/CNS 5 4 Bone Phase I Phase I/II Phase II Phase II/III Not Applicable Phase IV Phase III 3CTN Performance Report, created: June 5, 07 Recruitment database lock date: May 3, 07 7

19 Figure 5. Breakdown of personalized medicine trials at pediatric Network sites in fiscal year 06/07 Molecular targeted therapy, 6, 4% Study endpoint, 7, 6% Stratify into different groups,, 5% No personalized medicine component,, 5% Notes: Personalized medicine trials at pediatric Network sites, as of June 8, 07 (n=43) 49% of all trials at pediatric Network sites have a personalized medicine component; % of trials are immunotherapy related. Four trials were available at both adult and pediatric Network sites in fiscal year 06 and are included in both adult and pediatric figures Patient eligibility, 6, 4% 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: June 5, 07 Recruitment database lock date: May 3, 07 8

20 Figure 6. Breakdown of Portfolio trials at pediatric Network centres by lead country, in 06/07 Other,, 5% Canada only, 7, 6% Canada - International,, % Notes: Breakdown of trials at pediatric Network sites by lead country, as of June 8, 07 (n=43) 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 Four trials were available at both adult and pediatric Network sites in fiscal year 06 and are included in both adult and pediatric figures United States, 33, 77% 3CTN Performance Report, created: June 5, 07 Recruitment database lock date: May 3, 07 9

21 Section C: Portfolio Efficiency Objective: To improve patient access and increase in successful completion of trials Portfolio approval process timeline: Calendar Year # Application Completed Average Application Processing Time (days) Calendar Year # Application Completed Average FPR Time (days) Note: ) from application received to approve/decline the application since Jan 3, 05 to May 07; ) from date site agreed to pursue peer review to date last reviewer submitted completed peer review package to 3CTN (approved as peer reviewed). Section D: Other metrics Objective: To provide overall metrics to all sites. Complexity mix by number of total portfolio trials and patients accrued. Patient Scope Low Standard High # of trials Accrual (total) # of trials Accrual (total) # of trials Accrual (total) Overall 3% 50% 58% 40% % 0% Adults 3% 5% 59% 4% 9% 6% Peds 3% 3% 50% 4% 7% 56% *total data updated May 3, 07 3CTN Performance Report, created: June 5, 07 Recruitment database lock date: May 3, 07 0

22 Site efficiency National 450 Site Efficiency: Average Timelines from Local REB Site Submission to First Patient Recruited in Adult Centres by Region Ontario (4 sites; n=7) BC (6 sites; n=40) Quebec ( sites; n=50) Alberta ( sites; n=37) Manitoba ( site; n=9) Atlantic (7 sites; n=0) C7/Peds (7 sites; n=5) National Average (5 sites; n=93) Local Site REB Submission to Approval Local Site REB Approval to Site Open Accrual Site Open to Accrual to First Patient Recruited* 3CTN Performance Report, created: June 5, 07 Recruitment database lock date: May 3, 07

23 Region Sites # of portfolio fiscal year 06 Studies in 06 accrual (YTD (8 portfolio total) studies total, 69 recruiting sites) Total trials included for this efficiency calculation Activation Timeline from NOL/Sponsor Approval/Central Approval to Site Open to Accrual * Local Site REB Processing Time (site submission to approval) Local Site REB Approval to First Patient Recruited Site Open to Accrual to First Patient Recruited** Recruiting Period (from open to closed to accrual Site Accrual vs. Site Target Ontario % BC* % Quebec % Alberta % Manitoba % Atlantic % C7/Peds % National (adult % network sites) Definitions and formula: Timeline Activation Timeline from NOL/Sponsor Approval/Central Approval to Site Open to Accrual * Local Site REB Processing Time (site submission to approval) Local Site REB Approval to First Patient Recruited Site Open to Accrual to First Patient Recruited Recruiting Period (from open to closed to accrual) Site Accrual vs. Site Target Formula =site open to accrual - central approval or sponsor open to accrual or NOL (for C7 only) =local site REB approval date - local site submission date =first patient recruited to the site - local site REB approval date =first patient recruited to the site - site open to accrual date = site closed to accrual date - site open to accrual date = total accrual when closed/ site accrual set when the site open to accrual Note: - *Centralized approval dates were used for BC and Ontario, Peds used NOL, other sites used "sponsor approval" - first patients of peds and Alberta are by month and not exact dates - under setup trials not included 3CTN Performance Report, created: June 5, 07 Recruitment database lock date: May 3, 07

24 - only for portfolio start date greater than April, 04 and site open greater than April, 04 - Due to various available data, the above metrics are for references only. Appendix: Additional Notes Table 3. Reporting periods and dates Q4 04/5 Q4 06/7 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 Q 06/7 April June 06 August 3, 06 Q 06/7 July September 06 November 5, 06 Q3 06/7 October December 06 February 5, 07 Q4 06/7 January March 07 May 3, 07 *Dates not available as database lock implemented in Q 05/6 3CTN Performance Report, created: June 5, 07 Recruitment database lock date: May 3, 07 3