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SHARE Webinar: Why Should I Join a Clinical Trial with Dr. Hershman

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Dr. Dawn L. Hershman of the Herbert Irving Comprehensive Cancer Center at Columbia University presented the basics of clinical trials and emphasized how important it is for more patients to …

Dr. Dawn L. Hershman of the Herbert Irving Comprehensive Cancer Center at Columbia University presented the basics of clinical trials and emphasized how important it is for more patients to participate in them. She also discussed trials currently available for early stage and metastatic breast cancers. The webinar was presented on June 25, 2014. To hear the webinar, visit www.sharecancersupport.org/hershman

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  • 1. WHY SHOULD I JOIN A CLINICAL TRIAL? Dawn Hershman, MD, MS Associate Professor of Medicine and Epidemiology Leader, Breast Caner Program Herbert Irving Comprehensive Cancer Center Columbia University Medical Center NCI Community Oncology Research Program SWOG – Research Base Co-PI
  • 2. What is a clinical trial? • Clinical trials look at new ways to prevent, detect, control or treat disease. • The GOAL is to find if a new test or therapy is safe and effective. • It is important to have many types of people with different ages, races, ethnicities, and genders to see how different people respond to a treatment http://www.nih.gov/health/clinicaltrials/basics.htm
  • 3. What is a clinical trial? • Participants are assigned to receive one or more interventions (or no intervention) • Researchers evaluate the effects of the interventions on biomedical or health-related outcomes. • The assignments are determined by the study protocol. • Participants may receive a drug, treatment, procedure, or other types of interventions. http://clinicaltrials.gov/ct2/about-studies/glossary#C
  • 4. Clinical Research Categories • Interventional • Observational • Ancillary • Correlative
  • 5. Interventional • Individuals are assigned to receive intervention • Drug, Device or Other (ie behavioral) • Diagnostic, Therapeutic, Supportive Care • Assignment may or may not be random • Participants are followed and a health outcome is assessed
  • 6. Observational • Involves no intervention or alteration of the status of the participant • Biomedical or health outcomes are assessed in a pre-defined group of participants • Participants may or may not receive the intervention • The investigator is not responsible for assigning the specific intervention
  • 7. Observational Studies vs. RCTs Armstrong, K, JCO 2012;30: 4208-42144
  • 8. Strengths Observational Studies • Examine “real world” populations – Diversity increases generalizability • Large numbers of participants • Leverage existing data • Includes vulnerable populations • Power to find a dose response relationship • Can be completed more quickly with less cost
  • 9. Limitations of Observational Data • Selection Bias • Systematic error in the ascertainment of study subjects • Intervention groups differ in characteristics that are associated with the outcome of interest • Performance Bias • The delivery of one type of intervention is associated with generally higher levels quality of care • Detection Bias • Outcomes of interest are more easily detected in one group than another
  • 10. Ancillary/Correlative • Ancillary – Stimulated by a main clinical trial to answer secondary question – Includes patients accrued to the main study • Correlative – Laboratory based – Use specimens that exist – Used to assess risk, outcomes, response
  • 11. What are the types of clinical trials? Diagnostic: Protocols designed to evaluate interventions aimed at identifying a disease or health condition Prevention: Protocols designed to assess interventions aimed at preventing the development of a disease or health condition Screening: Protocol designed to examine methods for identifying a condition or risk of a condition in people not known to have the condition http://www.nih.gov/health/clinicaltrials/basics.htm
  • 12. What are the types of clinical trials? Treatment: Protocol designed to evaluate interventions for treating a disease Supportive Care: Protocol designed to evaluate interventions to maximize comfort, minimize side effects or prevent the decline in a health condition Health Care Deliver: Protocol designed to evaluate the delivery, processes, management, organization or financing of healthcare http://www.nih.gov/health/clinicaltrials/basics.htm
  • 13. Clinical trial stages
  • 14. Pre-clinical stage • A new drug or treatment is tested using animals to determine if it is safe for humans
  • 15. Phase I A new treatment is tested in a small number of people to see how safe it is and what are its side effects Involves 20-80 subjects
  • 16. Phase II A treatment is given to a larger number of people to see its effectiveness and safety Involves 100-300 people
  • 17. Phase III A treatment is tested in large number of people to prove that it is effective, check side effects, compare it to other treatments and get safety information Involves 1,000-3,000 people
  • 18. Phase IV A treatment is now approved by the FDA and available to the public but its usage, risks and benefits are still monitored
  • 19. What is a clinical protocol? • Studies are led by investigators who write the study protocol • Protocols describe: – Who can participate – The length of the study – What they will receive – What information is collected http://www.nih.gov/health/clinicaltrials/basics.htm
  • 20. What is a clinical protocol? Eligibility criteria are an important part of the protocol • Criteria often include: – Age – Gender Often not everyone – Type of disease meets criteria for – Stage of disease participation – Previous treatment – Medical conditions http://www.nih.gov/health/clinicaltrials/basics.htm
  • 21. How does a clinical protocol become approved? • Once an idea is formulated and the protocol written it must be reviewed • All clinical trials in the US are approved and monitored by an Institutional Review Board (IRB) http://www.nih.gov/health/clinicaltrials/basics.htm
  • 22. What is an IRB? An IRB is an independent committee of doctors, statisticians, and community members who review a study’s safety, human rights, and ethics
  • 23. Informed consent
  • 24. Informed consent • Understanding the procedures involved, risks and benefits of a study are extremely important when making decisions • The informed consent document and discussion are used to help you in this process • Translation and interpretive services are available during this time http://www.nih.gov/health/clinicaltrials/basics.htm
  • 25. Clinical trial concepts • Placebo: Inactive product that is very similar to the real drug or treatment but does has no affect on the condition • Randomization: A person is randomly assigned to one of any treatments in a study. Done to avoid bias or influence on the outcome • Single or double blinding: the subject doesn’t know the treatment (single) the subject and researcher do not know the treatment (double) http://www.nih.gov/health/clinicaltrials/basics.htm
  • 26. What happens once the clinical trial is over? • Analysis: All collected information is analyzed to see if there are any differences between treatment groups • Peer review: Experts review the analysis to see it is sound • Publication: Once it is past peer review it is published in a scientific journal http://www.nih.gov/health/clinicaltrials/basics.htm
  • 27. Why should I take part in a clinical trial? 1. Access to a new intervention that’s not normally available. 2. A new intervention may improve your health. 3. Most studies cover the cost of the intervention. 4. You are helping researchers answer questions about a disease. 5. You play an active role in your own health care. 1. A new intervention may not be better than the standard. 2. A new intervention has risks and side effects. 3. Your health insurance may not cover all costs. 4. If you are in a randomized study you will not be able to choose the intervention you receive. 5. You may need to make more visits to the clinic or hospital.
  • 28. NCI Clinical Trials • NCTN – National Clinical Trials Network • NCORP -NCI Community Oncology Research Program
  • 29. NCI Supports Community-Based Cancer Research • Majority of cancer care is provided in the community • Access to large diverse patient populations • Access to real world healthcare delivery settings • Test feasibility of new interventions/processes • Engage community oncologists in the research process to accelerate the uptake of evidence-based practice
  • 30. NCTN
  • 31. NCI Funding for NCTN
  • 32. NCORP Research Expansion
  • 33. Division of Cancer Control and Population Sciences (DCCPS) NCORP Associate Director Center to Reduce Cancer Health Disparities (CRCHD) Division of Cancer Treatment and Diagnosis (DCTD) Division of Cancer Prevention (DCP) NCORP Director NCORP Organizational Structure NCI NCORP Research Bases: NCTN Groups Cancer Centers Cancer Prevention and Control Trials Cancer Care Delivery Community Sites: NCORP NCORP-Minority/ Underserved Cancer Prevention and Control Trials Treatment Trials Cancer Care Delivery Extramural Investigators NCI-designated Cancer Centers Other Academic Centers Health Care Organizations Nonprofit Research Organizations Clinical Trials and Translational Research Advisory Committee (CTAC) Coordinating Center for Clinical Trials Evaluation and Prioritization of Research Concepts Steering Committee: Disease specific Symptom mgt./QOL Cancer Care Delivery Central Institution Review Board CIRB Cancer Trials Support Unit CTSU National Clinical Trials Network (NCTN) Treatment Trials
  • 34. Cancer prevention trials TARGET = Prevent breast cancer recurrence OR prevent breast cancer • DHA or placebo to prevent recurrence in breast cancer survivors • Vitamin D or placebo in premenopausal women at high risk for breast cancer • BFIT: 1st degree female relatives of breast cancer survivors receive an educational intervention
  • 35. Cancer treatment trials FOCUS = Receive intervention before OR after surgery • Receive propanolol prior to breast surgery to determine its effect on tumor growth • Receive metformin and atorvastatin prior to breast surgery to determine its effect on tumor growth
  • 36. Cancer treatment trials FOCUS = Receive intervention before OR after surgery • (B47) Randomly receive 1 of 4 chemotherapies after surgery • (B50) Receive a drug called TDM1 or Herceptin if breast disease is still present after surgery and received treatment prior to surgery • (S1207) Receive a drug called everolimus for high risk hormone positive and HER2 negative disease
  • 37. Metastatic treatment trials FOCUS = Receive intervention to prevent disease proliferation • Triple negative breast cancer patients: metformin and erlotinib • Metastatic patients with hormone sensitive Her2 Negative. Letrozole +/- palbocyclib
  • 38. Metastatic treatment trials • Metastatic Her-2 positive randomized to lapatinib + Xeloda vs. Neratinib + Xeloda • Bollero 4 – everolimus/letrozole +/- RAD Y24135 • LY2835219 – hormone sensitive her-2 negative • PD-L1 – Phase 1 • Her2 + - trastuzumab/ruxolitinib
  • 39. Symptom management trials FOCUS = Receive intervention to address side effects • True, sham or no acupuncture to treat joint pain caused by hormonal therapy • True or sham electroacupuncture to treat numbness during taxol chemotherapy • Menthol cream or placebo to treat numbness after chemotherapy
  • 40. Cancer survivorship trials FOCUS = Gather information on the physical & mental health of survivors • Exercise and Dietary intervention to decrease weight and improve outcome
  • 41. How do I find out about trials? • ONCOLOGISTS – ASK YOUR ONCOLOGIST - They are familiar with clinical trials resources, websites, and contacts • COMMUNITY RESOURCES – Local support groups – American Cancer Society • INTERNET – All trials are registered in the US and worldwide on clinicaltrials.gov • FRIENDS & FAMILY

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