Quarter Performance Report

Transcription

1 Canadian Cancer Clinical Trials Network Quarter Performance Report Quarter 07/8: April June 30, 07 Report Created: Sept 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 Appendix: Additional Notes... 3CTN Performance Report, created: September 8, 07 Recruitment database lock date: August 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 Figure. Number of Patients Recruited to Adult Portfolio Trials, Q3 04/5 - Q 07/8 447 Actual accrual Quarterly Target Number of Adult sites 47 Quarterly Network Target Notes: 00 patients were recruited to adult Portfolio trials in Quarter, 07/8. The Network recruitment target for 07/08 is 50% above baseline. The quarterly Network target for 07/08 is 98 patients recruited to meet an annual target of 367 patients recruited. The network is well on track for meeting the Y4 network target. Data include 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. 9 out of 49 adult sites exceeded their quarter baseline and 7 out of 49 adult sites exceeded their quarter target. Legend: Q3 Q4 Q Q Q3 Q4 Q Q Q3 Q4 Q below quarter baseline exceed quarter baseline and above target Q 07/8 progress against quarterly 06/7 Network target Actual Target Difference Accrual % above baseline 80% 50.0% 3CTN Performance Report, created: September 8, 07 Recruitment database lock date: August 3, 07

4 Figure. Number of patients recruited to adult Network sites per region in Q 07/8 Ontario British Columbia Quebec Alberta Atlantic Canada Manitoba Manitoba Atlantic Canada Alberta Quebec British Columbia Ontario 07/8 Quarterly Baseline Y4Q Actual CTN Performance Report, created: September 8, 07 Recruitment database lock date: August 3, 07 3

5 MB Atlantic AB BC Quebec* ON Figure 3. Number of patients recruited to adult Network sites per local-regional node (NCC + NACC) in Q 07/8 TOH 39 PM 83 SRI 4 JCC 66 LRCP 63 CODIM 7 CHUQ 87 CHUM 65 VC 9 CCI 6 TBCC 36 SJRH 6 NFL NSHA 9 CCMB CTN Performance Report, created: September 8, 07 Recruitment database lock date: August 3, 07 4

6 MB Atlantic AB BC Quebec* ON Figure 4. Progress to quarterly recruitment baseline at adult Network sites per region in Q 07/8 Ontario British Columbia Quebec Alberta Atlantic Canada Manitoba 89% 93% 7% % 97% 05% 0% 50% 00% 50% 00% 50% Figure 5. Percentage of patients recruited to quarter baseline of adult Network sites per local-regional node (NCC + NACC) in Q 07/8 PM SRI JCC LRCP CODIM CHUQ CHUM VC CCI TBCC SJRH NFL NSHA CCMB 50% 50% 6% 37% 5% 50% 4% 36% 0% 96% 89% 86% 33% 344% 0% 50% 00% 50% 00% 50% 300% 350% 400% 3CTN Performance Report, created: September 8, 07 Recruitment database lock date: August 3, 07 5

7 Table. Number of patients recruited per adult Network site (by fiscal year) Network Site **Y4 Baseline Y* Total Y Total Y3 YTD Total Q 07 Y4 YTD Total % of Y4 baseline 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 % Toronto East General Hospital % Humber River Hospital % Princess Margaret Cancer Centre % Northeast Cancer Centre - Health Sciences North 4 7 8% 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 % Mount Sinai Hospital* % The Ottawa Hospital % Kingston General Hospital % Lakeridge Health % CancerCare Manitoba % 3CTN Performance Report, created: September 8, 07 Recruitment database lock date: August 3, 07 6

8 Network Site **Y4 Baseline Y* Total Y Total Y3 YTD Total Q 07 Y4 YTD Total % of Y4 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)* % Tom Baker Cancer Centre % Cross Cancer Institute % Adult Patient Sites (N=49 for Y3, 48 for Y, and % for Y) 864 3CTN Performance Report, created: September 8, 07 Recruitment database lock date: August 3, 07 7

9 number 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 at adult Network sites per quarter, Q4 04/5 - Q 07/ Notes: There were 75 Portfolio trials in fiscal year 07 for adult sites, (YTD Total =3 newly added+5 closed YTD +67 previous recruiting trials) 3 news trials are included in the 70 recruiting trials at the end of Quarter 4 Three trials were available at both adult and pediatric Network sites in fiscal year 07 and are included in both adult and pediatric figures Q Q 05-6 Q 05-6 Q Q Q 06-7 Q 06-7 Q Q New Open Trials Added Q 07-8 Ongoing + Closed CTN Performance Report, created: September 8, 07 Recruitment database lock date: August 3, 07 8

10 Figure 7. Breakdown of 07 Fiscal Year Portfolio trials at adult Network sites Skin / Melanoma 4 Sarcoma Other Lung 0 4 Hematology 6 Head and neck 3 Gynecological 6 5 Genito-Urinary 8 Gastrointestinal Breast 5 9 Brain/CNS Not Applicable Phase I Phase I/II Phase II Phase II/III Phase III Phase IV Pilot/Feasibility The data provided in Figure 7 are a snapshot of the Portfolio as of September 8, 07 (N=75) 3CTN Performance Report, created: September 8, 07 Recruitment database lock date: August 3, 07 9

11 Figure 8. Breakdown of personalized medicine trials at adult Network sites for 07/08 Portforlio Trials Molecular targeted therapy,, % Study endpoint or objective, 8, 0% Stratify into different groups,, % Patient eligibility, 9, 7% No personalized medicine component, 05, 60% Notes: 65 Personalized medicine trials open to recruitment at adult Network sites, as of Sept 8, 07 (n=75) 40% of all trials at adult Network sites have a personalized medicine component Three trials were available at both adult and pediatric Network sites in fiscal year 07 and are included in both adult and pediatric figures There were 4 out of 75 (3.7%) immunotherapy related trials. 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: September 8, 07 Recruitment database lock date: August 3, 07 0

12 Figure 9. Breakdown of Portfolio trials at adult Network centres by lead country for 07/08 Portforlio Trials Other, 8, 4% Notes: Breakdown of trials at adult Network sites by lead country, as of May 3, 07 (n=75) Approx. 67% of all trials at adult Network sites are led by Canada 7% of which are international, multicentered studies The average number of adult Network sites per trial is Three trials were available at both adult and pediatric Network sites in 07/08 and are included in both adult and pediatric figures United States, 50, 9% Canada only, 05, 60% Canada - International,, 7% 3CTN Performance Report, created: September 8, 07 Recruitment database lock date: August 3, 07

13 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 - Q 07/ Actual accrual 90 Quarterly Target Q3 Q4 Q Q Q3 Q4 Q Q Q3 Q4 Q Quarterly Target Notes: 0 patients were recruited to Portfolio trials at pediatric Network sites in Quarter 07/8. The quarterly target for 07/8 is 30 patients recruited to meet an annual target of 5 patients recruited. Pediatric Network sites are 4% below its quarterly target for recruitment Data includes pediatric sites associated with the C7 Council (N=7) Legend: lower than quarter target Q 07/78 progress against quarterly target Accrual Target Difference Accrual % above baseline 6% 30% 3CTN Performance Report, created: September 8, 07 Recruitment database lock date: August 3, 07

14 Figure. Number of patients recruited per pediatric Network site in Q 07/8 CHU de Sherbrooke Allan Blair Cancer Centre Kingston General Hospital Janeway Child Health Centre Saskatoon Cancer Centre CancerCare Manitoba 6 CHU de Quebec IWK Health Centre 0 Stollery Children s Hospital 7 Children s Hospital, London Health Sciences Centre 3 Children s Hospital of Eastern Ontario 9 McMaster/Hamilton Health Sciences Centre 0 Alberta Children s Hospital 4 Montreal Children s Hospital 8 BC Children s Hospital 3 CHU Sainte-Justine 8 The Hospital for Sick Children CTN Performance Report, created: September 8, 07 Recruitment database lock date: August 3, 07 3

15 Figure. Progress to quarter baseline recruitment per pediatric Network site in Q 07/8 CHU de Sherbrooke Allan Blair Cancer Centre Kingston General Hospital 0% 0% Janeway Child Health Centre 00% Saskatoon Cancer Centre 67% CancerCare Manitoba 33% CHU de Quebec 4% IWK Health Centre 00% Stollery Children s Hospital 55% Children s Hospital, London Health Sciences Centre 00% Children s Hospital of Eastern Ontario 80% McMaster/Hamilton Health Sciences Centre 86% Alberta Children s Hospital 76% Montreal Children s Hospital 33% BC Children s Hospital 53% CHU Sainte-Justine The Hospital for Sick Children 76% 88% 0% 50% 00% 50% 00% 50% 300% 3CTN Performance Report, created: September 8, 07 Recruitment database lock date: August 3, 07 4

16 Table. Number of patients recruited per pediatric Network site (by fiscal year) Network Site **Y4 Baseline Y* Total Y Total Y3 YTD Total Q 07 Y4 YTD Total % of Y4 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 % Ped sites (N=7) total % 3CTN Performance Report, created: September 8, 07 Recruitment database lock date: August 3, 07 5

17 number 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 at pediatric Network sites per quarter Q4 04/5 - Q 07/ Notes: There were 40 Portfolio trials available at pediatric Network sites, 3 new trial added at the end of Quarter 07/08. The data provided in Figure 3 is a snapshot of the Portfolio as of September 8, 07. Three trials were available at both adult and pediatric Network sites in 07/8 and is included in both adult and pediatric figures Q Q 05-6 Q 05-6 Q Q Q 06-7 Q 06-7 Q Q New Open Trials Added Ongoing + Closed Q CTN Performance Report, created: September 8, 07 Recruitment database lock date: August 3, 07 6

18 Figure 4. Breakdown of Fiscal Portfolio trials at pediatric Network sites Sarcoma Other 3 Hematology 3 0 Genito-Urinary Gastrointestinal Brain/CNS 5 3 Bone Phase I Phase I/II Phase II Phase II/III Not Applicable Phase IV Phase III 3CTN Performance Report, created: September 8, 07 Recruitment database lock date: August 3, 07 7

19 Figure 5. Breakdown of personalized medicine trials at pediatric Network sites in fiscal year 07/08 Molecular targeted therapy, 6, 5% Stratify into different groups,, 5% Study endpoint, 7, 8% No personalized medicine component, 8, 45% Notes: Personalized medicine trials at pediatric Network sites, as of Sept 8, 07 (n=40) 55% of all trials at pediatric Network sites have a personalized medicine component Three trials were available at both adult and pediatric Network sites in 07 and are included in both adult and pediatric figures There were 0 out of 40 trials (5%) that were immunotherapy related trials. Patient eligibility, 7, 7% 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: September 8, 07 Recruitment database lock date: August 3, 07 8

20 Figure 6. Breakdown of Portfolio trials at pediatric Network centres by lead country, in 07/08 Other, 4, 0% Canada only, 7, 7% Canada - International,, 3% Notes: Breakdown of trials at pediatric Network sites by lead country, as of September 8, 07 (n=40) 0% of all trials at pediatric Network sites are led by Canada 3% of which are international, multicentered studies The average number of Network sites per trial is Three trials were available at both adult and pediatric Network sites in 07-08and are included in both adult and pediatric figures United States, 8, 70% 3CTN Performance Report, created: September 8, 07 Recruitment database lock date: August 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 of the application since Jan 3, 05 to September 8, 07; ) from date site agreed to pursue peer review to date last reviewer submitted completed peer review package to 3CTN (approved as peer reviewed). 3CTN Performance Report, created: September 8, 07 Recruitment database lock date: August 3, 07 0

22 Appendix: Additional Notes Table 3. Reporting periods and dates Q4 04/5 Q 07/8 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 Q 07/8 April June 07 August 3, 07 *Dates not available as database lock implemented in Q 05/6 ***Other metrics such as site efficiency related are reported on yearly basis 3CTN Performance Report, created: September 8, 07 Recruitment database lock date: August 3, 07