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Participating in Research and the Clinical Trials Process Claudia R. Baquet, MD, MPH Professor, Department of Medicine, and Associate Dean for Policy and Planning University of Maryland School of Medicine Assuring Diversity in Clinical Research Participation • A national priority • Minority, uninsured, poor, and rural communities have lower participation rates in medical research. • Underserved communities experience substantial health disparities. • Substantial barriers across multiple levels impede participation in clinical trials. • Building community-academic partnerships and community trust is essential. Fostering Public Trust in Research and Trial Diversity • Issues: • Lack of public trust and need for diversity in research participation • “Research Literacy” • Community: Lack of basic information on why research is important, how it is designed and reported; concern for “helicopter research; ethical protections for research participants • Community Primary Care Clinicians: Fear of losing control over patient care; distrust of academia and “stealing “patients; how to refer/enroll patients in studies; need for feedback from researchers Barriers to Research Participation • Patient • Health care professional • Structural or organizational • Knowledge and awareness in general public • Insufficient community infrastructure to support clinical research and trials • Historical factors Cancer Detection and Prevention University of Maryland Barriers to Clinical Trials Research Goal: examine the health behavior, clinical trials barriers, health care access, screening and health status of Maryland residents • Survey of 5,154 English-speaking, non-institutionalized men and women aged 18+ • 13 jurisdictions in Maryland (December 2001-March 2003), including: • urban Baltimore City • rural Western Maryland • rural Eastern Shore • Cross-sectional study design using random digit dialing (RDD) methodology • Clinical trial barriers and factors are predictive of participation and attitudes and information channels. Baquet CR, et al. Recruitment and Participation in Clinical Trials: Socio-Demographic, Rural/Urban, and Health Care Access Predictors. Cancer Detection and Prevention. 2006; 30. Maryland Clinical Trial Barriers Research Results • 80.0% of Blacks and 50.9% of Whites reported not knowing what a clinical trial is. • Over 95% reported their physician never discussed clinical research/trials. • 11.1% reported previous recruitment into clinical trials. • Of those, 59.4% actually participated in clinical trials. Baquet CR, et al. Recruitment and Participation in Clinical Trials: Socio-Demographic, Rural/Urban, and Health Care Access Predictors. Cancer Detection and Prevention. 2006; 30. Maryland Clinical Trial Barrier Research “Multivariate Predictors of Recruitment and Participation in Clinical Trials” • Were significantly more likely to be recruited: • in poor health (OR=1.83, CI=1.21-2.76), • had public health insurance coverage (OR=1.98, CI=1.57-2.51), and • had some college or higher level of education (OR=2.32, CI=1.84-2.92). • Were significantly more likely to actually participate: • informed about clinical trials by their health care provider (OR=1.69, CI=1.08-2.65), • knowledgeable about clinical trials (OR=2.09, CI=1.26-3.46), and • able to make the time commitment (OR=1.67, CI=1.06-2.63). • Black respondents were significantly less likely to be recruited (OR=0.61, CI=0.44-0.85) and less likely to participate (OR=0.38, CI=0.21-0.68) in clinical trials. Baquet CR, et al. Recruitment and Participation in Clinical Trials: Socio-Demographic, Rural/Urban, and Health Care Access Predictors. Cancer Detection and Prevention. 2006; 30. Journal Clinical Oncology Accrual of Maryland Cancer Patients to NCI sponsored Treatment Clinical Trials Study • Examined relationship of socio-demographic factors on accrual of Maryland cancer patients to NCI sponsored cancer treatment trials • n=2,240 Maryland cancer patients accrued onto NCI-sponsored treatment trials (1999-2002) Purpose: To determine extent to which Maryland cancer patients and patients residing in lower SES and/or rural areas were accrued to cancer trials and were representative of all cancer patients in Maryland. Data sources: • NCI’s Cancer Therapy and Evaluation Program (CTEP) for Maryland cancer patients • Maryland Cancer Registry • US Census and the Department of Agriculture Baquet CR, Ellison, G, Mishra, S et al. Analysis of Maryland Cancer Patient Participation in NCI Supported Cancer Treatment Clinical Trials. Journal of Clinical Oncology. July 2008. Accrual of Maryland Cancer Patients to NCI sponsored Treatment Clinical Trials Baquet CR, Ellison, G, Mishra, S et al. Analysis of Maryland Cancer Patient Participation in NCI Supported Cancer Treatment Clinical Trials. Journal of Clinical Oncology.July 2008. Maryland Community Clinical Trial Program Components • Research: Barriers and Strategies • Random digit dial (RDD) • Qualitative research • Results used to target educational/awareness efforts • Theory based education/outreach • Track accrual rates/trends • CTEP analysis • • Health care professionals • Trial referral • Continuing Education • Grand Rounds Training for Researchers • Community engagement • Faith-based • AHECs • Print Media • CBOs • Local Health Departments • FQHCs • Formal Partnerships • Policy Research and Advocacy • Community based infrastructure • Technical Assistance for elected officials and staff The Clinical Trials Process Learning Objectives Define a clinical trial Name the different types and phases of clinical trials Describe how participants are assigned to groups in “randomized clinical trials Know what a protocol is and its importance Know the benefits and risks of taking part in a clinical trial What are Clinical Trials? Research studies involving people Tests new ways to prevent, diagnose or treat disease Why are clinical trials important? Most of the best treatments are based on what we learned from clinical trials People with cancer and other diseases are living longer because of clinical trials Types of Clinical Trials Treatment trials Prevention trials Early-detection/screening trials Diagnostic trials Genetics trials Quality-of-life /supportive care trials Treatment Trials Evaluate the effectiveness of a new drug or treatment or a new way of using a standard treatment Test chemotherapies, vaccines, or new approaches to surgery or radiation treatment Prevention Trials Investigate different ways to reduce the risk of developing cancer Conducted in people who have never had cancer or cancer patients in remission to prevent a recurrence Early Detection/Screening Evaluate new ways of finding cancer in people before they have symptoms Conducted in people who do not have any symptoms of cancer Diagnostic Trials Test procedures for identifying cancer more accurately and at an earlier stage Conducted with people who have signs or symptoms of cancer Genetics Trials Examine the role that genes play in cancer risk or response to treatment Conducted with specific populations Look for genetic mutations by looking at DNA from blood or tissue samples Quality-of-Life/Supportive Care Investigate different ways to improve the comfort and quality of life of people who have cancer Phases of Clinical Trials Phase I: Is it safe? 15-30 people To find a safe dosage (how often it should be given?) To decide how the agent should be given (pill, injection or intravenous infusion) To observe how the agent affects the human body Participants are cancer patients who have no known effective treatment options Phases of Clinical Trials Phase II: Does it work? Less than 100 people To determine how well the new agent works against a particular cancer To see how the agent or intervention affects the human body The dosage found safe in Phase I is used Participants have been treated with chemotherapy, surgery, or radiation, but treatment has not been effective Phases of Clinical Trials Phase III: How well does it work? 100 – thousands of people To compare the new agent or intervention (or new use of a treatment ) with the current standard To find out if new treatment is better than, the same as or worse than standard treatment Eligible participants have an equal chance to be assigned to one or two more group (also called “arms”). One group gets standard treatment (control) Other group gets new treatment (investigational or intervention group) Phases of Clinical Trials Phase IV: How well does it work in the general population? Several hundred to several thousand people To further evaluate the long-term safety and effectiveness of a new treatment How Research Participants are Assigned to Groups Process called randomization (chance) using a computer to assign a participant to the intervention/investigational group or control group Control group gets standard treatment and investigational group gets new treatment being tested Used to prevent bias in research Occurs primarily in Phase III research studies Double blind – means that neither you nor the doctors know which people are taking the study agent or control agent Randomization Why is randomization important? So all groups are as alike as possible Provides the best way to prove the effectiveness of a new agent or intervention What is the Clinical Trial Protocol? A plan for the research study which acts like a “recipe” or blueprint for conducting the clinical trial Generated by the person in charge of the study, called a principal investigator What is included in a Protocol? Purpose of the study How many people will be in the study Who is eligible to participate in the study Any agents participants will take, the dosage, and how often What medical tests participants will have and how often What information will be gathered about the participants The endpoints of the study Benefits of taking part in a Clinical Trial Possible benefits: Patients will receive, at a minimum, the best standard treatment If the new approach is proven to work, patients may be among the first to benefit Patients have a chance to help others and improve cancer care Risks of taking part in a Clinical Trial Possible risks: Unknown side effects or other risks of new drug or treatment New treatment may not help every participants Costs (e.g. travel to clinical trial site) Resources Cancertrials.gov Cancer.org 1-800-4-CANCER American Cancer Society Clinical Trial Matching Service References A.J.S. Rayl. A Complete Guide to Clinical Trials. Mamm. Nov/Dec 2005 Cancer Clinical Trials: The Basic Workbook, Clinical Trials Education Series. U.S. Department of Health and Human Services. National Institutes of Health, National Cancer Institute. September 2002 Taking Part in Cancer Treatment Research Studies. U.S. Department of Health and Human Services. National Institutes of Health, National Cancer Institute. July 2007.