Outcomes & Opportunities through Collaborating in Clinical Trials

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1 Outcomes & Opportunities through Collaborating in Clinical Trials Tim Mullett, MD, FACS Professor of Surgery, Division of Cardiothoracic Surgery, Chief, General Thoracic Surgery, University of Kentucky, Surgical Director, Multidisciplinary Lung Cancer Clinic, Markey Cancer Center, Medical Director, Kentucky Clinical Trials Network

2 Financial Disclosure Statement Dr. Tim Mullett has no financial relationships to disclose.

3 Our Obligation is to serve Kentucky through Excellence in Patient Care and Research. Markey Cancer Center and our Partners can Lead Efforts to / and Impact the Burden of Cancer in Kentucky

4 WE ARE #1.

5 More than 75% of lung cancers are diagnosed in advanced stages. Stage Distribution (%) Breast Cancer Stage Distribution , All Ages, Races, Both Sexes (SEER) Prostate Cancer Colon and Rectum Cancer Lung and Bronchus Cancer Localized (confined to primary site) Regional (spread to regional lymph nodes) & Distant (metastasized)

6 Tremendous Challenges in Advancing Oncology Clinical Care to Prevent Disease, Improve Patient Response & Long-Term Outcomes FDA approved 34 new molecular and biological agents. 11 agents approved for cancer (more than any other therapeutic category) 0 agents were approved for lung cancer.

7 Commitments to Excellence in Cancer Care through Patient Care, Clinical Research and Education. Capitalize on Strengths of Programs to best serve Patients. o Institutional Goals & Commitments o Institutional Resources o Services Available o Regional Partnerships Clinical Research: o Advances Science o Elevates Patient Care to Approach Highest Levels o Provides Patients Access to Trials

8 Factors Influencing Patient Decision to Participate Because my family or friends recommended it 7 Because my doctor advised me to participate 13 To receive free medication and medical care To receive money for my participation To receive higher quality medical care 47 To find a better treatment To help myself and others/to advance science % Responding PAREXEL s Bio/Pharmaceutical R&D Statistical Sourcebook 2010/2011

9 Decision on How Best to Incorporate Clinical Trials into Your Practice. Goals & Resources: Goals: CoC Modest vs/ Robust Research Portfolio Therapeutic vs/ Non-Therapeutic Trials Resources: Financial Personnel Helpful Resource: NCI s Including Clinical Trials in Your Practice An Overview - This is a 2 ½ Hour Webinar

10 It s True...Oncology Clinical Trials are More Complex. Index of Clinical Trial Complexity by Therapeutic Area, All Phases, Worldwide, Oncology Pharmacokinetics Blood Disorders Digestive System Infectious Disease Endocrine and Metabolic Disease Central Nervous System Pain Transplantation Musculoskeletal System and Ophthamology Genitourinary System Respiratory Dermatology Cardiovascular PAREXEL Biopharmaceutical R&D Statistical Sourcebook 2012/1013

11 Successful Research Partners Contribute to Clinical Trials, via Direct Study Conduct &/or Referral. 1. Referral: o Evaluate & Refer to MCC Provides Your Patient with Access to important therapeutic trials Simplified Process Reduced Regulatory Responsibilities Reduced Resources o MCC Portfolio Strong Trial Portfolio 2. Clinical Trial Conduct: o Clinical Research Program Operations Resources Commitments Engagement Regulatory Responsibilities 3. Combination of Both

12 Kentucky Clinical Trials Network An initiative of the Kentucky Lung Cancer Research Program

13 Kentucky Lung Cancer Research Program (KLCRP): Established in 2000 by Kentucky General Assembly to stimulate research in lung cancer. (KRS ) Priority Initiatives: Early Detection & Epidemiology NCI Designation Investigator-Initiated research Statewide clinical trials network to increase availability of trials in Kentucky communities.

14 KCTN: Mission: Improve care of Kentuckians who suffer from cancer by increasing access to clinical trials. Provide innovative clinical trials, support and education for our research centers and scrupulous quality assurance. Alliance of physicians conducting clinical trials in the prevention, early detection, and treatment of lung cancer. Multidisciplinary Approach IITs & Industry sponsored trials; Phases I IV

15 KCTN Coordinating Center - housed at Markey Cancer Center Site Membership Study & Site Selection Network Committee & Data Safety Monitoring Committees Research Education & Training Monitoring & Quality Assurance Auditing Data Management Project Development & Management Centralized Recruitment Support Contract & Budget Negotiation Regulatory; support, Central IRB

16 Research Opportunities in Kentucky: Increase access to innovative cancer clinical trials Research Closer to Home: Patients remain in their community Trusted physicians Physicians: Clinical Trial Opportunities Expand Research Enterprise Pick & Choose Trials Study Portfolio: Interventional: Therapeutic, Prevention, Supportive Care Interventions Non-Interventional: Screening, Early Detection, Epidemiologic/Observational, Behavioral, Biospecimen

17 Patients & Families search trials by Site, Physician, Rx, Treatment, Phase

18 Membership: Commitment to conduct research in compliance with CFR, GCP, ICH & KCTN regulations and guidelines. Onboarding Process: Research Goals of Institution Identify Leadership & Key Team Members Membership Application Questionnaire Regulatory Documents Human Subjects Protection Training Membership Agreement Site Visits Standard Operating Procedures NPRC: Scientific & Ethical Review of Protocols

19 Member Commitments: Code of Federal Regulations (CFR) Good Clinical Practices (GCP) Belmont Report: Respect for Persons Beneficence DO NO HARM Justice fair distribution of benefit and risks Institutional Assurance (FWA) & IRB Registrations: Institutional FWA with OHRP Registered IRB (local or Central)

20 Investigator Responsibilities: Personally Conduct & Oversee Conduct of Trial Form FDA 1572, Statement of Investigator Multiple parts, 21 CFR Parts 312, 50, 54, 56, and 11 FDA Guidance Document Investigator Responsibilities Protecting the Rights, Safety, and Welfare of Study Subjects, Oct 2009

21 Study Chair Support: Assist to meet GCP & CFR responsibilities of Sponsor- Investigator (21 CFR 312.3) Select Qualified Investigators (21 CFR ) Inform Investigators (Safety, Amendments, Ongoing Progress) Select Qualified Monitors & Ongoing Review of Investigation Maintain Adequate Records (Safety, FD, TMF) Assure IRB Reviews Project Planning Teams Concept Feasibility

22 Study Pipeline Spotlights: Optimal Smoking Cessation Strategy as Therapeutic Intervention in Lung and Head and Neck Cancers: Study Chairs: Joseph Valentino, MD Jamie Studts, PhD Background: Smoking during treatment decreases efficacy of lung and head and neck cancer treatment. Series of randomized smoking cessation intervention trials: 1. Optimal Intervention Strategy High Intensity Counseling (Motivational) or SOC smoking cessation Various approved cessation drugs 2. Phase II trials with/without this strategy with endpoints of response, survival.

23 Study Pipeline Spotlights: Concurrent anti-angiogenic and cytotoxic chemotherapy to standard WBRT for RPA class II brain metastases from non-squamous NSCLC Study Chair: John L. Villano, MD, PhD, Director of Clinical Neuro- Oncology, Markey Cancer Center Endpoints: Overall Survival, Quality of Life and Cognitive Status exams. Plan: Site Selection late summer 2013

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