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Clinical Trials in the Age of Personalized Cancer Medicine: The Evolution of a More Efficient, Patient Focused Clinical Research System Session Chair:

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Presentation on theme: "Clinical Trials in the Age of Personalized Cancer Medicine: The Evolution of a More Efficient, Patient Focused Clinical Research System Session Chair:"— Presentation transcript:

1 Clinical Trials in the Age of Personalized Cancer Medicine: The Evolution of a More Efficient, Patient Focused Clinical Research System Session Chair: Eric Lynam Vice President Business Development Pharmatech Oncology Inc.

2 Disclaimer The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. (“DIA”), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated. These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, DIA and DIA logo are registered trademarks or trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners.

3 Session Update Program Substitution – Eric Lynam DH for
Matthew B. Wiener, Pharm.D. Pharmatech Oncology Founder and COO Unable to participate today due to injury

4 Session Learning Objectives
Define rare cancers by histological and molecular definitions List three challenges in conducting oncology clinical trials in rare cancers Discuss modifications in workflow that enable greater research efficiency through patient-focused project management Discuss regulatory solutions which permit patient focused research while providing proper oversight and patient protection

5 Clinical Trials in the Age of Personalized Cancer Medicine
ASCO 2009: ‘Personalizing Cancer Care’ ASCO 2010: ‘Advancing Quality Through Innovation’ “Oncology is no longer a one-size-fits-all medicine" – Richard Schilsky, MD "We are increasingly able to tailor treatments to an individual's or to a tumor's unique biology, which ultimately helps us to improve outcomes for patients by matching the right treatment to the right patient at the right time.“

6 Challenges to Oncology Clinical Trials
US cancer patients are treated in thousands of independent practices Participation is clinical trials remains low (<5%) How to connect the right investigational treatments to the right patients to develop targeted therapies? How to deliver investigational treatment options to more patients within context of patient care? How to accelerate research and ensure protection of patients, in compliance with GCP and CFR 21?

7 Dr. Jeffrey Vacirca Clinical Trials in Oncology: Re-examining the Site-based Research Paradigm

8 The Evolution of a More Efficient, Patient Focused Clinical Research System
Migration from a site centered system to a patient and treatment focus Patient first system requirements Network of qualified, research ready sites Identify candidate patients where they present Connect patients to appropriate clinical trial treatment opportunities Rapid trial entry – Need to treat in weeks not months Logistical Alignment – Site supply, initiation, training Full compliance with CFR 21, GCP and all study oversight measures

9 Just In Time Research Model
Wait for Patients (weeks, months, or more) Site Based Research Protocol Review SQV IRB Site Approval SIV Training Pre-Identify Patient Qualify, Consent, & Enroll Diminishing Study Awareness Cost & Risk Patient Based JIT Research Protocol Review Pre-Identify Patient IRB Site Approval SQV/SIV Training Qualify, Consent, & Enroll Avg. 10 Days Look for Patients

10 What Makes Just In Time a Potential Solution?
Higher throughput patient ID and enrollment rate Broader detection by many sites Immediate enrollment increases trial enrollment rate Alignment of administrative activities to immediate enrollment opportunities No lag between site initiation and first patient consent Few or zero non-enrolling sites Efficient use of sponsor resources, materials, start up costs Secondary enrollment X Factor. High study awareness

11 JIT Research and Protection of Human Subjects
Can research administration be accelerated and still comply with CFR 21 and GCP? Are patient rights properly protected in a JIT research model?

12 Matt Baker Protecting Patient Rights and Regulatory Compliance in a Patient-Directed Clinical Research System

13 Feasibility Of JIT Research Model Collaboration Between Sponsor and CRO
Adapted from S. Gevorkian, F. Patterson PRCT Annual Meeting March 2010

14 Case Studies

15 Sponsor Conclusions from CML Trial
More JIT sites that were opened actually enrolled subjects More than half of total US subjects enrolled came from JIT sites with few screen failures Streamlined processes decreased time to execute steps to qualify, initiate, and enroll subjects Model is not ‘one size fits all’: Conduct realistic feasibility assessment whether right for your therapeutic area, study protocol, and organization Ensure adequate resources are identified and part of study budget Buy-in from different groups within the organization is key and should be sought early in the decision-making process Partner with SMO to establish a clear and comprehensive work flow Ensure commitment and planning on both sites to execute deliverables in a time sensitive and intense environment S. Gevorkian, F. Patterson PRCT Annual Meeting March 2010

16 Future Directions: Patient Focused Oncology Research
Further R&D – Solutions like Just In Time Commercial and NIH supported Expanded Connectivity Trial registries (e.g. ClinicalTrials.gov) Patient Matching (e.g. advocacy, enrollment support organization) Systematic Integration National healthcare (e.g. NCI, caBIG) Patient care - Any patient to any research site

17 Conclusions - Discussion
Development of personalized cancer therapies requires much greater patient participation in US (5%  20%) Greater availability of trials across research practices Greater access for individual patients to appropriate cancer trials Meet all regulatory, documentation, and patient protection commitments Alignment of research activities with patient care needs One solution currently in development through Just In Time method Thank you for your participation!


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