Get know to us! Objectives. Clinical trial accrual is decreasing! Why is accrual to trials so low? Coordinating Pragmatic Trials

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1 Clinical Research Week 2016 Coordinating Pragmatic Trials Get know to us! Carol Stober CRA & Sasha Mazzarello CRC Objectives Current Clinical Trial Model What is a Pragmatic Trial? What is REaCT? Integrated Consent Model Current REaCT trials Coordinating a REaCT trial Where are we headed? Clinical trial accrual is decreasing! Why is accrual to trials so low? Research coordination/ management Physician engagement Written consent process Current Clinical Trial Model High drug costs Challenges of traditional clinical trials Ethics board submission Ave. Cost: $26,000/patient Contracts Patient engagement Superfluous data collection 1

2 Pragmatic trials What is a Pragmatic Trial? A randomized controlled trial whose purpose is to inform decisions about practice. Patsopoulos NA. A pragmatic view on pragmatic trials. Dialogues Clin Neurosci 2011 Jun; 13(2): Pragmatic trials Strengths Represents the real world practice by including diverse patients, clinical settings, and outcomes Comparison of 2 active treatments Better able to determine treatment effectiveness Weaknesses Difficult to blind Often requires larger sample sizes than traditional randomized trials What is REaCT? Meyer AM et al. An overview of methods for comparative effectiveness esearch. Semin Radiat Oncol Jan;24(1):5 13. REthinking Clinical Trials (REaCT) Program Established in 2014 Questions around: 1. The traditional trials model 2. Areas of clinical equipoise Our current mandate To compare fully funded standard of care agents To improve patient care To provide practical guidance for care To reduce health care disparities To save health care dollars To challenge current research processes within an ethical framework 2

3 Standard of care Interventions in common use, already known to be efficacious or approved by Health Canada for its required indication Elements of REaCT trials 1. Selection of clinically relevant and practical questions 2. Demonstration of clinical equipoise (surveys and systematic reviews) 3. Appropriate study design and simply defined study end points 4. Integrated consent model incorporating oral consent 5. Efficient research ethics board approval 6. Web based randomization in the clinic 7. Real time data capture and management Kim SY, Miller FG. Informed consent for pragmatic trials the integrated consent model. N Engl J Med Feb 20;370(8): Traditional consent Every step leads to attrition & cost Integrated consent Research Ethics Board Same work up as other trials Minimal impacts on departments, if any OCREB for multi centre trials Initial approval granted within 3 4 months of study submission 3

4 Web based randomization in clinic Web based randomization in clinic Randomize eligible and consented patients in the clinic with either a mobile device or on desktop Website includes: Checklist of eligibility criteria Dictation elements for the physician to include in EMR Randomization by either the physician or clinical research personnel to physician when the patient next comes to clinic data capture Embrace the change for the better! Current open trials I don t know how many of you have not moved to a new phone? New technology replacing old ones! 1. REaCT TC: cipro vs. G CSF 2. REaCT G: 5 vs. 7 vs 10 days of Neupogen 3. REaCT Mg: Mg oxide vs Mg citrate 4. REaCT TNBC: dd AC P every 2 weeks vs dd AC P weekly vs FEC D 5. REaCT EF: MUGA/ECHO every 3 vs 4 months 6. REaCT VA trastuzumab: PICC vs PORT 7. REaCT VA Her2 : Central line vs periperal access 8. REaCT BTA: BTA every 4 weeks vs 12 weeks A simple example, what dose and how many days of filgrastim do patients need? Filgrastim (or a similar but more expensive drug) is used with nearly all adjuvant breast cancer regimens. We do not know the optimal dose 480mcg $ mcg $ What is standard of care? A survey of medical oncologists showed everyone is doing what they think is right. 5, 7, 10 days This results in massive differences in cost to the Health Care System 4

5 REaCT G concept A Multi Centre Study to Determine the Feasibility of using an Integrated Consent Model to Compare Standard of Care Administration Schedules of G CSF (filgrastim) for primary prophylaxis of Chemotherapy Induced Febrile Neutropenia in Early Stage Breast Cancer (React G Study) Primary endpoints: Feasibility Physician engagement Time for REB approval Accrual rates Patient/physician compliance Secondary endpoints: FN hospital admissions Chemotherapy changes ANC results CRA role What is the role of the CRA? Confirming completion of oral consent dictation 3 key elements Ensure data collection completed via physician followup tool Real time data entry and CRF completion Advantages and Challenges Advantages: Challenges: Patient involved in decisionmaking Comprehensive study overview Efficient use of CRA time Pertinent data collection Appropriate treatment follow up Timely fashion of clinic workflow Efficient REB approval Opportunity for a variety of healthcare professionals to lead trials Encouraging investigator involvement Less patient engagement if you enjoy the interaction The e mail reminders often have to be adjusted manually 5

6 Where are we headed? Future Directions Real time data collection using electronic forms Getting more sites involved More departments involved Do you see any areas in your field of work where a REaCT trial would be appropriate? 6