Thursday, April 23. Incorporating ClinicalTrials.gov Into Patient Education and Care Coordination. Session 1:30 3 pm Valencia BC

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1 Session 1:30 3 pm Valencia BC Incorporating ClinicalTrials.gov Into Patient Education and Care Coordination Clinical trials play a significant role in improving cancer treatment, symptom management, and healthcare delivery. Patients seeking clinical trial options often rely on oncology nurses to help them navigate the process. ClinicalTrials. gov is a registry and results database of publicly and privately supported clinical studies that can be used to assist patients and family members interested in clinical trials. Learn more about it and how you can use its search tools, study statuses, and trial results data in your patient education. Target Audience: Registered Nurses, Advanced Practice Nurses Level of Content: Advanced Speaker: Kandie Dempsey, MS, RN, OCN Director, Cancer Research Christiana Care Health Services Neward, DE Full Disclosure: Nothing to Disclose Speaker: Rebecca J. Williams, PharmD, MPH Assistant Director, ClinicalTrials.gov National Library of Medicine, National Institutes of Health Bethesda, MD Full Disclosure: Nothing to Disclose Objectives: At the end of this session, participants will be able to: 1. Understand the context for educating individuals about oncology clinical trial participation. 2. Gain knowledge on the scope of ClinicalTrials.gov, the tools available for finding studies, and tips for navigating the contents of a study record. 3. Identify key elements to discuss with individuals who are considering participating in research. Bibliography: American College of Surgeons. (2012). Cancer program standards Retrieved from cancer/coc/standards American Society of Clinical Oncology. (2008). ASCO outlines minimum standards and exemplary attributes for research sites: Previews tools to be provided. Journal of Oncology Practice, 4(4), doi: /jop JOP American Society of Clinical Oncology. (2012). Policy statement: Oversight of clinical research. Journal of Clinical Oncology, 21(12), Retrieved from content/21/12/2377.full.pdf Meropol, N.J., Buzaglo, J.S., Millard, J., Damjanov, N., Miller, S.M., Ridgway, C.,... Watts, P. (2007). Barriers to clinical trial participation as perceived by oncologists and patients. Journal of the National Comprehensive Cancer Network, 5(8), Michaels, M. (2012, October). Addressing challenges in cancer trials accrual: A look in the mirror. Applied Clinical Trials. Retrieved from National Cancer Institute & National Institutes of Health. (2002). Cancer clinical trials: A resource for outreach, education, and advocacy (Publication No ). Retrieved from alnet.cancer.gov/sites/accrualnet.cancer.gov/files/resource- Guide_Book_m.pdf National Cancer Institute. (2013). Learn about clinical trials: What are clinical trials? Retrieved from National Institutes of Health. (2014). HHS and NIH take steps to enhance transparency of clinical trial results. Retrieved from National Institutes of Health. (2015). ClinicalTrials.gov background. Retrieved from background Prayle, A.P., & Hurley, M.N. (2012). Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: Cross sectional study. British Medical Journal, 344, d7373. Retrieved from Schilsky, R.L. (2011). Accrual to cancer clinical trials in the era of molecular medicine. Science Translational Medicine, 3(75), 1 2. Retrieved from Williams, S. (2004). Clinical trials recruitment and enrollment: Attitudes, barriers, and motivating factors [A summary of literature and market research reports held by NIC as of August 2004]. Retrieved from trials_recruitment_and_enrollment.pdf Zarin, D.A., Tse, T., & Sheehan, J. (2015). The proposed rule for U.S. clinical trial registration and results submission. The New England Journal of Medicine, 37(2), Retrieved from Zon, R.T., Bruinooge, S.S., & Lyss, A.P. (2014). The changing face of research in community practice. Journal of Oncology Practice, 10(3), Retrieved from Oncology Nursing Society 40th Annual Congress 1

2 What are Cancer Clinical Trials? research studies conducted with people to find better ways to prevent, diagnose and treat cancer May include new drugs, approaches to surgery or radiation therapy, combinations of treatments or methods such as gene therapy. Final step moving basic scientific research from the laboratory into treatments for people with cancer. Yesterday s Clinical Trials are Today s Treatments How do we know how to treat patients? How do we know which types of treatments are effective in treating specific cancers? What modality should be used? What toxicities should we expect? What outcomes can be anticipated? How are results communicated? Why Do We Need Clinical Trials? Prevent Treat Control Decrease incidence and mortality Improve Quality of Life Decrease the cost of cancer care Problem Significance No standard effective treatments exist for many types of cancer. Further improvement of effective therapies is needed for all cancers. Communication of clinical trial results. Barriers to Participation Participant Lack of information/awareness. Lack of access. Fear, distrust or suspicion. Financial and personal concerns. Physician Lack of awareness Loss of control of patients care Belief that standard therapy is best Concern of additional administrative burdens Lack of Awareness Publication facilitates the open exchange of information among researchers, and increasingly with patients. Not all research can be published in peer reviewed journals! Notion of bad research if positive findings are not indicated. 2 Oncology Nursing Society 40th Annual Congress

3 Lack of Awareness 40% of adults report that they do not understand the idea of a clinical trial NCI Survey 85% of cancer patients were not aware of clinical trials however, 75% would have participated if they have known it was possible. Care Coordination/Navigation Education is required for both the patient and the health care team with regards to clinical trial availability. Health care providers may provide clinical trial: Education Care Coordination Navigation Search Tools NCI, 2012; Williams, 2002 About ClinicalTrials.gov Clinical studies registry and results database Over 183,000 studies (trials & observational studies) Studies with locations in all 50 states and >180 countries Privately and publicly funded studies involving humans Study information submitted by sponsors or principal investigators Web Site & registry launched in February 2000 Results database, in September 2008 >16,000 studies with results Database updated nightly Usage 98 million page views per month 64,000 visitors per day Data as of February 10, Content of a Study Record (One Record per Unique Study Protocol Single NCT Number) Protocol section Submitted at trial initiation; updated throughout trial lifecycle Summarizes information from trial protocol: e.g., Condition Interventions Study Design Includes recruitment information (e.g., eligibility, locations) Results section Submitted after trial completion/termination Summarizes trial results Participant flow Baseline characteristics Outcome measures (including statistical analyses) Adverse events 10 Why Register and Submit Results? Ethical and Scientific Rationale Responsibility to research participants, patients, and the public Research integrity Evidence based medicine Required by various policies and laws Selected Policies and Laws Journal editor requirement for publication (ICMJE) Registration (prospective) for all interventional studies U.S. Federal Law (FDAAA 801) Registration & results for applicable clinical trials of drugs, biologics, and devices Results currently limited to approved products (but proposed to expand to include unapproved) NIH encourages for all NIH supported trials Registration & results for all clinical trials (including those not subject to FDAAA 801) Proposal issued by NIH in Nov 2014 to make this a requirement 11 ICMJE = International Committee of Medical Journal Editors FDAAA 801 = Section 801 of the Food and Drug Administration Amendments Act of 2007 (U.S. Public Law ) 12 Oncology Nursing Society 40th Annual Congress 3

4 Sample Uses of ClinicalTrials.gov Identify trials of potential interest for an individual or user community Track progress of a specific trial and availability of summary results Identify completed or ongoing trials for specific conditions/interventions Supplements a literature review Identify researchers and/or centers of relevance to specific conditions/interventions Methods for Finding Trials Basic Search Advanced Search allows for a focused search See Studies by Topic Conditions/Rare Diseases, Drugs, Dietary Supplements, Sponsor/Collaborators, Locations See Studies on Map Search Results Tools RSS Feed Receive automatic updates on a specific search Download Search Results Choose study fields to include Select file format (tab and comma separated values format is appropriate for a spreadsheet) Additional Resources ClinicalTrials.gov Online Training brief animated tutorials Topics currently available: Basic Search, Advanced Search, Customize Your Display, Downloading Search Results, Modify a Search, RSS Feed Setup for a Search, Study Record Details Find Studies: Why Should I Register and Submit Results?: Clinical Trial Participation Impact Expands beyond patient care and education. Institute of Medicine A National Cancer Clinical Trials System for the 21 st Century: Reinvigorating the NCI Cooperative Group System ASCO Exemplary Clinical Trial Site Characteristics Commission on Cancer Accreditation Cancer Program Standards Transparency ClinicalTrials.gov provides easy access to publicly and privately supported clinical trials on a wide range of diseases and conditions. Reporting of positive and negative findings helps researchers prevent unnecessary duplication of trials. Establishes trust with clinical trial participants that information is put to maximum use to further knowledge about their condition. 4 Oncology Nursing Society 40th Annual Congress

5 Enhancing Clinical Trial Awareness Promote trial involvement through education. Many people do not have access to Internet. Nurse navigators, clinical research nurses and oncology nurses in general may identify potential participants. Education through Community partnerships, patient advocates, support groups, churches, senior centers before diagnoses are made. Enhancing Awareness If patients aren t being offered clinical trial participation, they aren t being provided with all of their treatment options! Clinical Trial results have not been consistently reported to trial participants ClinicalTrials.gov provides another avenue for the information to be provided. Oncology Nursing Society Resources ONS Oncology Clinical Trials Competencies Communicate Educate Advocate ONS Special Interest Group Clinical Trials Nursing Share Best Practices ClinicalTrials.gov The advancement of medicine requires broad access to clinical trials and their findings. It is our responsibility to fulfill ethical obligations to human research volunteers by: Registering trials and submitting summary results Contributing towards the dissemination of information regarding the tools and resources available to health care professionals and the individuals we serve. ClinicalTrials.gov Compliance with reporting provides public assurance that the rights, safety and well being of trial subjects are protected and that clinical trial data are credible. Principles are translated into legal requirements. Exemplary clinical trials sites, incorporate timely and accurate clinical trial awareness and requires the engagement of health care professionals in the clinical trial education and awareness process. Tools to Reach Your Audience Investigators Tumor conferences, MDCs, newsletters, brochures, posters, educational venues Community Investigators, referring MDs, website, radio/tv, newspaper, posters, newsletter Oncology Nursing Society 40th Annual Congress 5

6 Target Your Message Clinical trial participation is essential in reducing cancer burden. Clinical trial availability raises the bar of oncology practice in your community. Clinical Research is a team effort. Research cures cancer. Conclusion Clinical trial success depends on accrual. Increase trial awareness in both the lay and physician community. Area resources influence marketing efforts. Research is not complete until it has been reported! Need to build upon what has been learned. ClinicalTrials.gov Conclusion Conducting research is an integral part of our profession and serves the mission of improving survival and the quality of life for cancer patients. ClinicalTrials.gov education may improve accrual and assist in maximizing opportunities for clinical trial participation. ClinicalTrials.gov helps to ensure data is generated and disseminated in a timely manner. Information Resources clinicaltrials nursing second edition research/clinicaltrial resources 6 Oncology Nursing Society 40th Annual Congress