HBV Clinical Trials and Why They Are Important. Presenters: Robert G. Gish, MD, FAASLD Moon S. Chen, Jr, PhD, MPH
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1 HBV Clinical Trials and Why They Are Important Presenters: Robert G. Gish, MD, FAASLD Moon S. Chen, Jr, PhD, MPH
2 What Is a Clinical Trial? Studies in which people volunteer to test new drugs or devices Learn whether new treatment works and is safe for people Therapies in clinical trials NOT the same as available drugs (roucne care) Available therapies have been tested & approved
3 Why Are Clinical Trials Important? New treatments must pass many tests before they get to pacents Can advance science and help others in the future Other consideracons: PaCents may access therapies in development Tests, treatment usually free for study volunteers PaCents may be observed more closely during trial
4 What Does the Healthcare Provider Do in Clinical Trials? Physician (principal invescgator, PI) Organizes & directs the study Reviews the data Clinical research coordinator Handles day-to-day accvices Main contact for pacents Image courtesy of stockimages at FreeDigitalPhotos.net
5 How to Find HBV Clinical Trials ClinicalTrials.gov- lists all clinical trials Local academic and nonacademic insctucons Pharma companies website liscngs HepaHHs B FoundaHon ( - info@hepb.org - Call HBV specific liscng - Provides contact informacon for trial site (contact research team)
6 How to Find HBV Clinical Trials Center for InformaHon & Study on Clinical Research ParHcipaHon MED HERO ( Free service to help find appropriate clinical trials locally or further away - Send you contact informacon for research studies ~1 week ; regular mail: 2 weeks Free educaconal brochure (key quescons to ask research staff) Can also search their CenterWatch clinical trials database yourself
7 How Can Healthcare Providers Get Involved in a Trial? Create database of pacents in their praccce viral disease, liver disease, demographics Publish arccle on their pacent profile Approach pharma companies Establish a research infrastructure Publish
8 If Healthcare Provider Is Not Involved in a Clinical Trial If a provider is not involved in a trial but his/her pacent wants to parccipate: Referral to research center Submit intake form if available Transfer records a^er complecng HIPAA forms Can scll remain involved in pacent s care
9 Barriers to ParCcipaCng in Clinical Trials The Healthcare Provider PerspecHve
10 Clinical Trials Can Affect PracCce Some trials can run months, years Establish protected Cme for clinical trials Allocate staff just for clinical trials Budget own Cme and staff Cme to balance the business aspect of disease
11 Other Barriers to Clinical Trials Lack of awareness about new drugs, trials Lack of urgency for pacents to enter trial 7 effeccve treatments available SubstanCal costs associated with clinical trials
12 Healthcare Provider Concerns PaCents may not want to parccipate PaCents may not adhere to protocol Language, cultural barriers Take Cme off work, need to travel to trial site May lose pacents to clinical trial site
13 Key Messages for Healthcare Providers About HBV Clinical Trials To build a database of HBV pacents, providers must take the following steps: 1. Test for HBV in all at-risk pacents 2. Test for anc-hbc; if posicve do not vaccinate; educate about risk of reaccvacon 3. Prevent HBV with vaccinacon if all three HBV tests are negacve
14 Key Messages for PaCents About Clinical Trials 1. Currently no cure for HBV infeccon 2. ExisCng treatments: lifelong, have side effects 3. New drugs with potencally shorter therapy and greater effeccveness could prevent hepaccs B-related: a. deaths b. liver transplants c. liver cancer
15 Talking About Clinical Trials: Strategies to Promote and MoCvate Talking to individuals with HBV Face-to-face meecngs about HBV beder than telephone discussions Use enduring materials, pictures, graphics, videos Talking to healthcare providers WHO plan to eliminate HBV worldwide by 2030 MenCon the 30+ new therapies in development for HBV, with the next step being a funcconal cure
16 Your Roles in Increasing Asian Americans ParHcipaHon in HBV Clinical Trials Moon S. Chen Jr., PhD, MPH Co-Founder, NaHonal TF on HBV: Focus on APIs Professor & Associate Director for Cancer Control UC Davis Comprehensive Cancer Center
17 ObjecCves From Review to Realiza,on From RealizaHon to Responsibili,es From ResponsibiliHes to Roles
18 ObjecCves From Review to Realiza,on
19 Asian American Cancer Mortality Trends Reported By Race/ Ethnicity Table 1. Top 5 sites of cancer-related mortality, ranked as a proporcon of all cancer deaths, by race/ethnicity ( ) Thompson, C. A., Gomez, S. L., HasCngs, K. G., Kapphahn, K., Yu, P., Shariff-Marco, S., Palaniappan, L. P. (2016). The Burden of Cancer in Asian Americans: A Report of NaConal Mortality Trends by Asian Ethnicity. Cancer Epidemiology, Biomarkers & PrevenCon: A PublicaCon of the American AssociaCon for Cancer Research, Cosponsored by the American Society of PrevenCve Oncology, 25(10), hdps:// doi.org/ / epi
20 Asian Americans with Chronic HBV US DEMOGRAPHICS Asian Americans 6%
21 Our cancer burden is unique, because, among all racial groups in the United States, Asian Americans were the first to experience cancer as the leading cause of death. In all other racial groups, heart disease is the leading cause of death.
22 The cancer burden that affects Asian Americans is unusual, because more than any other racial/ ethnic group, Asian Americans experience proporhonally more cancers of infec,ous origin, such as liver cancer, cervical cancer, and stomach cancer.
23 Liver & IntrahepaCc Bile Duct Cancer Mortality Rates for Males USA, per 100,000 Asian/Pacific Islander American Indian/Alaska NaCve Hispanic Non-Hispanic Black 12.8 Non-Hispanic White Siegel RL et al. Cancer StaCsCcs, 2016; CA Cancer J Cln 2016; 66:7-30
24 Liver & IntrahepaCc Bile Duct Cancer Mortality Rates for Females USA, Per 100,000 American Indian/Alaska NaCve 6.3 Asian/Pacific Islander 6.1 Hispanic 5.6 Non-Hispanic Black 4.4 Non-Hispanic White Siegel RL et al. Cancer StaCsCcs, 2016; CA Cancer J Cln 2016; 66:7-30
25 The cancer burden that affects Asian Americans may be unnecessary, at least in part, because prevenhon is beder than a cure and earlier detechon and other behavioral changes can reduce the risk of dying from cancer or acquiring cancer.
26 ObjecCves From RealizaHon to Responsibili,es
27 Reducing Cancer Health DispariCes Among Asian Americans: Progress & Prognosis
28 Kaplan-Meier Curves of Cause Specific Survival from HCC
29 Thousand Asian American Study (TAAS)
30
31 Clinical Trials YouTube Link
32 PerspecCves
33 Paradigm TOOLS TRUSTWORTHINESS TANGIBLE BENEFITS TIME TRUST
34 PaCent s PerspecCve AGE DEMOGRAPHICS VALUES CULTURAL COMMUNICABILITY SOCIAL HERITAGE
35 HOW: FACILITATORS Doctor-recommended Trust earned Cultural sensitivity Linguistic competence
36 Does This Work? Brown M, Moyer A. Predictors of awareness of clinical trials and feelings about the use of medical informacon for research in a naconally representacve US sample. Ethnic Health. 2010;15: Tong EK, Fung LC, Stewart SL, PaterniC DA, Dang JHT, Chen MS Jr. Impact of a biospecimen colleccon seminar on willingness to donate biospecimens among Chinese Americans: Results from a randomized, controlled community-based trial. Cancer Epidemiol Biomarkers, & PrevenCon 2014 Dang JHT, Rodriguez EM, Luque JS, Erwin DO, Meade CD, Chen MS Jr. Engaging diverse populacons about biospecimen donacon for cancer research. Journal of Community GeneCcs 2014 Yes, minorihes are willing to parhcipate in health research Yes, TRUST is the key
37 ObjecCves From Review to Realiza,on From RealizaHon to Responsibili,es From ResponsibiliHes to Roles
38 Asian American Community Responses to Blood Biospecimen Drives: Findings and ImplicaCons
39 The 3 R s: Roles and ResponsibiliCes If you are: Healthcare provider. Your responsibilices are: Recommend clinical trials to your pacents Person with HBV Public health or community group. Request that your provider inform you about clinical trials Be a Resource for linking providers and pacents to clinical trials
40 How to Find HBV Clinical Trials Clinicaltrials.gov HepaHHs B FoundaHon info@hepb.org CISCRP (Search Clinical Trials) MED HERO ( Local academic / nonacademic insctucons PharmaceuCcal company websites
Analyzing National, Institutional, Provider, & Patient Perspectives for Enhancing Minority Participation in Clinical Trials
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