Quarter Performance Report

Canadian Cancer Clinical Trials Network Quarter Performance Report Quarter, FY 08/9 (Year 5): July Sept. 30, 08 Report Created: January 4, 09

Table of Contents Section A: Patient access and recruitment to the 3CTN Portfolio Trials... Patient Recruitment at All Network Sites... Number of patients recruited and number of Portfolio trials per Network site (by fiscal year)... 3 Patient recruited to 3CTN Portfolio trials BC, Alberta and Manitoba... 3 Number of active recruiting 3CTN Portfolio trials BC, Alberta and Manitoba... 4 Patient recruited to 3CTN Portfolio trials Ontario... 5 Number of active recruiting 3CTN Portfolio trials - Ontario... 6 Patient recruited to 3CTN Portfolio trials Atlantic Region and Quebec... 7 Number of active recruiting 3CTN Portfolio trials Atlantic Region and Quebec... 8 Section B: 3CTN Portfolio Metrics... 9 Active Recruiting Portfolio trials by disease site and phase... 9 Active Recruiting Portfolio trials by study type and special features... 0 Overall Portfolio Complexity (Jan Dec 08)... 0 Portfolio Impact Assessment... Portfolio application efficiency... 4 Appendix: Additional Notes... 5 Table : Site Efficiency definitions... 5 Table : Study Impact Criteria Definitions... 7 Table 3. Reporting periods and dates Q4 04/5 Q4 08/9... 8 3CTN Performance Report, created: January, 09 Recruitment database lock date: November 30, 08/Portfolio snap shot date: December 3, 08

Section A: Patient access and recruitment to the 3CTN Portfolio Trials Patient Recruitment at All Network Sites Objective: To improve patient access to academic clinical trials and improve patient recruitment by greater than 75% within four years Y5 (Q+Q) Recruitment % to Annual Recruitment Target Progress to annual target Median Cumulative Quarterly Target 90% 80% 70% 60% 56% 50% 40% 30% 50% 35% 0% 0% 0% Alberta British Columbia Manitoba Atlantic Ontario Quebec Adults Pediatrics All Notes: 977 patients were recruited to Portfolio trials in Quarter, 08/9. Y5 target is to achieve 55% above pre-3ctn baseline. Although the Q+Q accrual did meet the overall cumulative quarterly Network target of 854 patients, most regions did not meet their quarterly recruitment targets. TMIST contributed 47 of total recruitment of Ontario, accounting for 0% of Network total recruitment. Overall, 39% of sites (6 out of 46) are on track of meeting the annual target and 3% (6 out of 46) have already achieved their Y5 3CTN Performance Report, created: January, 09 Recruitment database lock date: November 30, 08/Portfolio snap shot date: December 3, 08

Number of patients recruited and number of Portfolio trials per Network site (by fiscal year) Objective: ) to improve patient access to academic clinical trials and improve patient recruitment by greater than 75% within four years; ) to increase the number of active recruiting trials per site by 50%, compared to pre 3CTN baseline, by 0 Patient recruited to 3CTN Portfolio trials BC, Alberta and Manitoba Network Site Pre- 3CTN Baseline Q 08-9 Q 08-9 Y5 Total % of baseline % to Y5 Target CancerCare Manitoba 99 8 5 43 43% 8% Prairie Mountain Health 0 0 0 0% 0% CancerCare Manitoba - Pediatrics 8 3 7% % CancerCare Manitoba Total 8 0 6 46 39% 5% BC Cancer Agency - Vancouver Centre 06 3 53 50% 3% Abbotsford Centre 6 5 4 9 56% 36% Centre for the North, Prince George 4 5 500% 33% Sindi Ahluwalia Hawkins Centre for the Southern Interior 38 5 4 9 50% 3% Vancouver Island Centre 6 8 8 36 38% 89% British Columbia Cancer Agency 87 60 6 65% 4% Alberta Health Services, Cross Cancer Institute 0 4 4 66 65% 4% Alberta Health Services, Tom Baker Cancer Centre 76 4 34 58 76% 49% Alberta Health Services 78 66 58 4 70% 45% Western Region Total 483 46 46 9 60% 39% 3CTN Performance Report, created: January, 09 Recruitment database lock date: November 30, 08/Portfolio snap shot date: December 3, 08 3

Number of active recruiting 3CTN Portfolio trials BC, Alberta and Manitoba Network Site Q 08-9 Q 08-9 CancerCare Manitoba 8 7 Prairie Mountain Health 0 0 CancerCare Manitoba - Pediatrics 7 7 BC Cancer Agency - Vancouver Centre 5 5 Abbotsford Centre 4 4 Centre for the North, Prince George 3 3 Sindi Ahluwalia Hawkins Centre for the Southern Interior 9 0 Vancouver Island Centre 5 6 Alberta Health Services, Cross Cancer Institute 3 33 Alberta Health Services, Tom Baker Cancer Centre 34 30 3CTN Performance Report, created: January, 09 Recruitment database lock date: November 30, 08/Portfolio snap shot date: December 3, 08 4

Patient recruited to 3CTN Portfolio trials Ontario Network Site Pre- 3CTN Baseline 3CTN Performance Report, created: January, 09 Recruitment database lock date: November 30, 08/Portfolio snap shot date: December 3, 08 Q 08-9 Q 08-9 5 Y5 Total % of baseline % to Y5 Target Without TMIST London Health Sciences Centre 86 63 49 60% 39% 39% Grand River Regional Cancer Centre 0 8 9 7 85% 55% 55% Windsor Regional Cancer Centre 4 6 4 0 7% 46% 46% Hamilton Health Sciences, Juravinski Cancer Centre 8 3 77 09 5% 74% 74% Cambridge Memorial Hospital 0 9% 6% 6% St. Joseph's Healthcare Hamilton 4 3 7 9% 83% 83% Walker Family Cancer Centre, Niagara Health System 7 8 4 7% 46% 46% Sunnybrook Health Sciences Centre, Sunnybrook Research Institute 4 38 83 3 8% 47% 6% Humber River Hospital 4 400% 58% 58% Michael Garron Hospital (Toronto East General Hospital) 0 00% 65% 65% Princess Margaret Cancer Centre 396 99 49 348 88% 57% 57% Markham Stouffville Hospital 0 0 0 0% 0% 0% Mount Sinai Hospital 3 5 4% 5% 5% Northeast Cancer Centre - Health Sciences North 4 7 6 3 54% 35% 35% North York General Hospital 3 300% 94% 94% Royal Victoria Regional Health Centre 8 4 3 7 88% 56% 56% Southlake Regional Health Centre 0 9 6 35 350% 6% 6% St. Michael's Hospital 9 0 5% 3% 3% Thunder Bay Regional Health Sciences Centre 6 8 3 8% 5% 5% Trillium Health Partners 7 4 3 7 6% 7% 7% William Osler Health System 0 0 0 0% 0% 0% The Ottawa Hospital Cancer Centre 3 8 0 383 90% 87% 69% Cancer Centre of Southeastern Ontario at Kingston General Hospital 4 3 5 7% 8% 8% Lakeridge Health, RSM Durham Regional Cancer Centre 4 6 7% 8% 8% NRCC Ontario Subtotal,33 846 750 596 % 78% 57%

Number of active recruiting 3CTN Portfolio trials - Ontario Network Site Q 08-9 Q 08-9 London Health Sciences Centre 45 46 Grand River Regional Cancer Centre 8 8 Windsor Regional Cancer Centre 4 4 Hamilton Health Sciences, Juravinski Cancer Centre 9 7 Cambridge Memorial Hospital St. Joseph's Healthcare Hamilton 3 Walker Family Cancer Centre, Niagara Health System 8 7 Sunnybrook Health Sciences Centre, Sunnybrook Research Institute 3 34 Humber River Hospital 3 3 Michael Garron Hospital (Toronto East General Hospital) Princess Margaret Cancer Centre 7 74 Markham Stouffville Hospital 0 0 Mount Sinai Hospital 4 4 Northeast Cancer Centre - Health Sciences North 6 7 North York General Hospital 3 4 Royal Victoria Regional Health Centre 8 6 Southlake Regional Health Centre 9 0 St. Michael's Hospital Thunder Bay Regional Health Sciences Centre 5 5 Trillium Health Partners 3 3 William Osler Health System The Ottawa Hospital Cancer Centre 38 37 Cancer Centre of Southeastern Ontario at Kingston General Hospital 6 5 Lakeridge Health, RSM Durham Regional Cancer Centre 3 4 3CTN Performance Report, created: January, 09 Recruitment database lock date: November 30, 08/Portfolio snap shot date: December 3, 08 6

Patient recruited to 3CTN Portfolio trials Atlantic Region and Quebec Network Site Pre- 3CTN Baseline Q 08-9 Q 08-9 Y5 Total % of baseline % to Y5 Target Nova Scotia Health Authority 39 7 9 49% 3% Eastern Regional Health Authority 5 4 5 33% % Janeway Child Health Centre 4 0 0 0 0% 0% Atlantic NRCC total 58 6 8 4 4% 7% CISSS de l'outaouais 3 0 0 0 0% 0% CHU de Québec Université Laval, adults 80 38 59 33% % CIUSSS de l Estrie Centre hospitalier universitaire de Sherbrooke, adults (CIUSSS-Estrie-CHUS) 46 6 4 0 % 4% Centre Hospitalier de l'université de Montréal (CHUM) 53 33 7 60 39% 5% CIUSSS du Nord-de-l Île-de-Montréal(CIUSSS NDIM) 3 0 3 3 00% 65% CIUSSS de l Est-de-l Île-de-Montréal(CIUSSS-EDIM) 60 9 5 4 3% 5% CHU de Quebec - Pediatrics 7 7 3 0 59% 38% Centre hospitalier universitaire de Sainte-Justine 4 0 9 9 45% 9% Montreal Children s Hospital 4 3 3% 8% Quebec Clinical Research Organization in Cancer (Q-CROC) 58 05 73 78 34% % Eastern Region Total 586 8 0 34% % 3CTN Performance Report, created: January, 09 Recruitment database lock date: November 30, 08/Portfolio snap shot date: December 3, 08 7

Number of active recruiting 3CTN Portfolio trials Atlantic Region and Quebec Network Site Q 08-9 Q 08-9 Nova Scotia Health Authority 6 Eastern Regional Health Authority 4 6 Janeway Child Health Centre 9 CISSS de l'outaouais CHU de Québec Université Laval, adults 9 0 CIUSSS de l Estrie Centre hospitalier universitaire de Sherbrooke, adults (CIUSSS-Estrie-CHUS) 3 Centre Hospitalier de l'université de Montréal (CHUM) 3 34 CIUSSS du Nord-de-l Île-de-Montréal (CIUSSS NDIM) CIUSSS de l st-de-l Île-de-Montréal (CIUSSS-EDIM) 3 CHU de Quebec - Pediatrics 3 6 Centre hospitalier universitaire de Sainte-Justine 30 Montreal Children s Hospital 5 5 3CTN Performance Report, created: January, 09 Recruitment database lock date: November 30, 08/Portfolio snap shot date: December 3, 08 8

Section B: 3CTN Portfolio Metrics Active Recruiting Portfolio trials by disease site and phase Objective: To monitor and optimize the portfolio in order to create opportunities for new trials and demonstrate 3CTN s impact. Breakdown of Active Recruiting Portfolio trials for the Network sites (N=59) Other 4 9 4 Melanoma 3 Lung 6 5 Hematology 4 Head and neck 3 Gynecological 5 Genito-Urinary 9 4 3 Gastrointestinal 7 5 Breast 5 Brain/CNS 6 5 Bone 0 5 0 5 0 5 30 35 Phase IV Phase III Phase II/III Phase II Phase I/II Phase I Pilot/Feasibility Not Applicable *as of Dec. 3, 08 3CTN Performance Report, created: January, 09 Recruitment database lock date: November 30, 08/Portfolio snap shot date: December 3, 08 9

Active Recruiting Portfolio trials by study type and special features 6 (38.9%) Personalized Medicine Trials 7 (%) Immunotherapy Trials 59 Recruiting Portfolio Trials 94 (59%) led by Canada 63 (39.6%) Phase III Randomized Overall Portfolio Complexity (Jan Dec 08) Complexity mix by number of total portfolio trials (N=9 excluding TMIST trial) as of December 3, 08 and YTD patients accrued report. Patient Scope Low Standard High # of trials Recruited (total) # of trials Recruited (total) # of trials Recruited (total) Overall 6% 47% 60% 48% 5% 5% Adults 6% 47% 60% 48% 4% 5% Peds 6% % 54% 57% 30% % 3CTN Performance Report, created: January, 09 Recruitment database lock date: November 30, 08/Portfolio snap shot date: December 3, 08 0

Portfolio Impact Assessment Objective: To provide a more specific and translatable impact description of 3CTN Portfolio trials to existing and future stakeholders. As part of the continuing plan for implementing the 3CTN Portfolio Impact Assessment Criteria (see appendix table ), a review of an initial set of 3 completed trials with publications was conducted. The assessment will be reviewed by Portfolio Committee. All Portfolio trials will be assessed and results will be updated quarterly. Preliminary Results Completed Portfolio trials with Publications Category Breakthrough trial Cross cancer trial Enhancement /derivative trial Platform trial Sustaining trial Total # of Trials per Study Criteria Lifestyle Interventions 3 4 Novel therapy 9 6 4 8 5 43 Patient management 6 4 6 33 Precision medicine 9 9 8 48 8 70 Rare cancer setting 4 4 30 Vulnerable populations 3 5 4 3 5 33 Total # of Trials per Impact on Patient Population Criteria 0 4 69 4 3 3CTN Performance Report, created: January, 09 Recruitment database lock date: November 30, 08/Portfolio snap shot date: December 3, 08

Break-down of Novel Therapy Trials by Disease Site Novel Therapy Trials Overview (N=43) 6 4 0 8 7 Sustaining trial Platform trial Enhancement/derivative trial Cross cancer trial Breakthrough trial 6 4 0 7 3 4 3CTN Performance Report, created: January, 09 Recruitment database lock date: November 30, 08/Portfolio snap shot date: December 3, 08

Overview of Portfolio applications Objective: To increase the number of Portfolio applications received per year by 5% by 0. Since Jan. 05, there have been 46 applications received in total with an acceptance rate 8%. As of December 3, 08, received 44 applications were received for the year, which was comparable to total for 07. The following graphs provide a monthly comparison of the last two years. Portfolio Application Status Summary Jan 07- Dec 07 (N=45) 5 Declined Approved 0 5 0 0 5 5 4 3 4 Jan-7 Feb-7 Mar-7 Apr-7 May-7 Jun-7 Jul-7 Aug-7 Sep-7 Oct-7 Nov-7 Dec-7 Portfolio Application Status Summary Jan 08- Dec 08 (N=44) Declined Approved Under 3CTN review 0 8 6 4 0 9 4 5 4 Jan-8 Feb-8 Mar-8 Apr-8 May-8 Jun-8 Jul-8 Aug-8 Sep-8 Oct-8 Nov-8 Dec-8 3CTN Performance Report, created: January, 09 Recruitment database lock date: November 30, 08/Portfolio snap shot date: December 3, 08 Q 08/9 Q 08/9 Q3 08/9 3

Portfolio application efficiency Objective: To improve portfolio application processing time Portfolio Approval Process Timeline Calendar Year # Application Completed Average Application Processing Time (days) Median Application Processing Time (Days) 05 89 4 8 06 70 4 6 07 45 9 6 08 4 4 5 Facilitated Peer Review (FPR) Process Calendar Year # Application Completed Average FPR Time (days) Median FPR Time (days) 05 6 47 33 06 0 98 79 07 4 79 53 08 6 78 76 Note: ) from application received to approve/decline the application since Jan 3, 05 to Dec. 08; ) 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: January, 09 Recruitment database lock date: November 30, 08/Portfolio snap shot date: December 3, 08 4

Appendix: Additional Notes Table : Site Efficiency definitions Metric Definition/formula 08-0 Target Source Frequency Reported Start date of site activation process to Site Open to Accrual (New!) =site open to accrual start date of site activation process Note: Start Date of Site Activation Process/Date Site Confirmed Participation= the date that the site has the critical decision and package to start the trial activation process (whichever date is later):) access to the protocol;) the site PIs has expressed interest in the trial; 3)the site has confirmed its participation as a site through a formal or informal review process [refined definition] 300 days (average) Site Quarterly Centralized Site REB Processing Time (Lead applicant submission to approval) Local Site REB Processing Time (site submission to approval) =Centralized site REB approval date - Centralized site submission date =local site REB approval date - local site submission date Local Site REB Approval to First Patient Recruited =first patient recruited to the site - local site REB approval date Site Open to Accrual to =first patient recruited to the site - site open to First Patient Recruited accrual date Recruiting Period (from = site closed to accrual date - site open to accrual open to closed to accrual date Site Accrual vs. Site Target = total accrual when closed/ site accrual set when the site open to accrual 90 days (average) Site/ethics board 90 days (average, if not using centralized process) Site Semi-annual Quarterly 7 days (average, if the site is not a lead applicant and only needs to submit supplementary material) 90 days (average) Site Quarterly 60 days (average) Site Quarterly 300 days (average) Site Quarterly Sites recruited to 60% of site target 40% of sites recruiting greater than 75% of site target Site Quarterly 3CTN Performance Report, created: January, 09 Recruitment database lock date: November 30, 08/Portfolio snap shot date: December 3, 08 5

SOPs Sites to use regulatory compliant clinical trial 00% of sites Site Annual operations standard operating procedures (SOPs) CTRNet Number of sites who have registered with CTRNet 00% of sites Site Annual 3CTN Performance Report, created: January, 09 Recruitment database lock date: November 30, 08/Portfolio snap shot date: December 3, 08 6

Table : Study Impact Criteria Definitions Impact Assessment Impact Category Proposed Definition Potential Impactful Study Criteria Potential Impact on Patient Population Innovativeness of Trials Novel Therapy Rare Cancer Setting Patient Management Vulnerable Populations Lifestyle Interventions Precision Medicine Breakthrough Trial Platform Trial Enhancement/ Derivative Trial Sustaining Trial Cross Cancer Trial Incremental Paradigm Shifting Trials involving newly developed intervention (e.g. drug, novel biomarker or diagnosis) As defined by the National Cancer Institute Cancer Facts and Figures 07, cancer that occurs in <5 out of 00,000 people each year (e.g. mesothelioma, nasopharynx, gallbladder, soft tissue) Patient education, awareness, self- assessment trials, symptom control Pediatric, AYA, elderly, organ dysfunction Trials focused on lifestyle changes that may prevent, decrease severity and/or delay disease progression and treatment side effects (e.g. exercise, diet) Biomarker, immunotherapy, diagnosis, and targeted therapies Trial involving a first in class, or novel intervention (drug, biologic, technology or technique) that could dramatically change how people with a particular type of cancer are treated Using already available interventions for new types, settings or stages of cancer Using additional targeting biomarker screening to tailor treatment and investigate outcomes Calibrating/focusing on dosages, treatment cycles or schedule (e.g. colon cancer adjuvant 3-6 months) Results applied to multiple disease sites or basket/umbrella trials Potential for iterative changes/advancement (e.g. next in class drugs) Potential for radical improvements in cancers/policy changes within cancer, or across a cancer spectrum (e.g. first in class drugs in phase III trials; introduction of new previously unused intervention or approach; first trials of OncotypeDx in local breast cancer that transformed patient management; first immunotherapy trials) 3CTN Performance Report, created: January, 09 Recruitment database lock date: November 30, 08/Portfolio snap shot date: December 3, 08 7

Table 3. Reporting periods and dates Q4 04/5 Q4 08/9 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 Q 07/8 July September 07 September 30, 07 Q3 07/8 October December 08 December 3, 08 Q4 07/8 January March 08 May 5, 08 Q 08/9 April June 08 August 3, 08 Q 08/9 July September 08 November 30, 08 Q3 08/9 October December 08 February 5, 09 Q4 08/9 January March 08 May 3, 09 *Dates not available as database lock implemented in Q 05/6 3CTN Performance Report, created: January, 09 Recruitment database lock date: November 30, 08/Portfolio snap shot date: December 3, 08 8