Understanding Of Clinical Research Research Articles

Understanding how nurses can effectively utilise social media for increasing public involvement, recruitment and impact dissemination of Clinical Research Trials.

The methodologies for clinical research trials are evolving to greater usage of social media platforms, providing opportunities to incorporate smart technologies in their delivery. Research Nurses should consider how they can utilise platforms for public engagement in trials. To explore the experiences of social media platforms and clinical research trials in a healthy population group, to gain insight into how clinical researchers can utilise these platforms professionally and ethically. Using a critical realist qualitative focus group design with template analysis, we recruited 16 healthy members of the public aged 18-75 years. The data expands upon their thoughts and behaviours regarding social media platforms with their understanding of clinical research. Three main themes along with their specific subthemes (1) Design: Patient and Public Involvement (Subtheme: Understanding of clinical research, Diversity of social media users), (2) Implementation: Recruitment to active studies, (Subtheme: Motivators for volunteering, Trustworthy), (3) Dissemination: Impact and Awareness of Results, (Subtheme: Information overload, Motivations for users to share information). This study has highlighted the need to consider the way different population groups use social media platforms and the information they share when looking to engage them in clinical research trials.

Medical School Clinical Trials Educational Intervention: Impact on Knowledge and Attitudes.

Medical student knowledge and opinions of clinical research have important ramifications for how likely they will be to refer patients into clinical trials as practicing physicians. This study examined students understanding, knowledge, and attitudes about clinical trials at the start of medical school and after completion of a multi-faceted intervention designed to increase medical students' confidence in understanding and explaining clinical trials during the pre-clinical and clinical years. Medical students were surveyed about their knowledge of and attitudes toward clinical trials in their first (N = 724) and third (N = 191) years of medical school. During the intervening years, students attend a lecture delivered by University of Hawai 'i Cancer Center faculty, were provided a resource manual from National Cancer Institute, participated in two problem-based learning clinical scenarios, and completed an optional practicum. After completing the comprehensive clinical trials education, there were significant increases in student understanding and knowledge and a decrease in student perception that clinical trials exploit participants. Most students agreed or strongly agreed that inclusion of clinical trials in the curriculum was important and would influence their future practice. Integration of clinical trials education into the medical school curriculum improved students' understanding of clinical research, their ability to communicate the clinical trials process, and confidence in conducting, referring to, and locating clinical trials. Medical students appreciate the importance of clinical trials in advancing medicine and medical education. Further integration of clinical trials education and opportunities to engage in research during medical school are warranted to address students' uncertainty about the benefits of participation for patients.

Abstract B076: A qualitative exploration of women’s understanding of clinical research and decisions to participate: Improving diversity in clinical research

Abstract BACKGROUND: Twenty-nine years since the National Institutes of Health (NIH) Revitalization Act was passed to encourage minority participation in clinical trials (CTs), and yet there remains a deficit of minorities recruited into CT. This induces the idea that Women-of-Color (WoC) (Blacks, Latinas, Native Americans, Asians) are less likely to participate than their Northern/European White (NE/W) counterparts. Using a mixed methods study that included quantitative surveys and qualitative interviews, we dive into understanding how a diverse group of women understand and perceive CT, along with concerns and attitudes towards clinical research. METHOD: The interview script was designed to capture patients’ understanding and concerns of clinical research, reasons for agreeing or declining participation, and facilitators or barriers to participation. The CRAs were trained in establishing rapport with the patient, clearly communicating the questions, and probing for more elaboration of responses. Interviewees and interviewers were matched based on gender and race. A total of four CRAs conducted the interviews – two Asian CRAs interviewed the Asian participants, one Latina CRA interviewed Latinas and White, non-Hispanics, and one African American CRA who interviewed the African American participants. Structured individual interviews were conducted by trained CRAs. The audio-recordings of all interviews were transcribed word for word and reviewed for accuracy. Two independent coders then read and coded each transcript and extracted a set of quotes (phrases or sentences) that reflected the themes. RESULTS: A total of 44 women were accrued between August 2019 and February 2020. The racial/ethnic makeup include the following: 20 Latinas ([White/Hispanic] - one Salvadorian, one half Mexican/half Armenian, and 18 Mexican), 8 Asian (one half Chinese/half Japanese, one Indian, three Chinese, two Vietnamese, one Thai), 8 African American/non-Hispanic, and 8 White/non-Hispanic (two Iranian and 6 European). Age range of women were 27 to 71 years of age. Seventeen women declined participation. CONCLUSION: The in-person interviews highlighted feelings of cultural mistrust among the WoC participants and not in the NE/W participating in the study. The results highlight the influence of cultural mistrust as a barrier and the importance of diversity of the clinical research team in overcoming this barrier, particularly among WoC clinical trial participants. Of course, there is undeniable heterogeneity within the WoC population; each community is influenced by its own historical and present contexts that influence its relationship with the medical system. Approaches to overcome this barrier must address the specific needs of each community. Diversity of the clinical research team and the ability of the team to address culturally relevant beliefs can increase trial diversity. The generalizability, quality, and effectiveness of healthcare treatment requires diverse representation in all clinical trials. Citation Format: Veronica Jones, Noe Chavez, Vanessa M. Robles, Laura Kruper, Lily Lai, Amy Polverini, Lusine Tumyan, Lesley Taylor, James Waisman, Angelica Sanchez, Christine Thai, Tanya Chavez, Nikita Wright. A qualitative exploration of women’s understanding of clinical research and decisions to participate: Improving diversity in clinical research [abstract]. In: Proceedings of the 15th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2022 Sep 16-19; Philadelphia, PA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2022;31(1 Suppl):Abstract nr B076.

Decision-making about clinical trial options among older patients with metastatic cancer who have exhausted standard therapies

ObjectivesOlder adults under-enroll in early phase cancer clinical trials. There are limited data on their trial experiences, which hampers our ability to understand potential reasons and responses to under-enrollment. We aimed to explore older adults' experiences and deliberations with phase 1 trials. Materials and MethodsWe analyzed 101 in-depth interviews with 39 adults (average 2.6 interviews per participant) about their experiences with phase 1 trials. All respondents were ≥ 65 years and had advanced cancer. Interviews lasted 60–90 min and were audio-recorded, transcribed, and analyzed to identify respondents' understanding of clinical research, perceptions of early phase trials, and experiences with enrollment. ResultsClinical trial participation was an interactive process that unfolded over time. Older adults relied on ongoing guidance and discussion with their oncologist to navigate the process. Respondents were generally interested in life-prolonging therapies, including enrollment in early phase clinical trials, but did not necessarily state this explicitly to their oncologist. While respondents did not mention age as a limitation to trials participation, participants age > 70 were less enthusiastic about participation and more often discussed their quality of life and weighed benefits of trial participation in the context of their remaining months of life. ConclusionEarly phase clinical trial enrollment is complex, and older adults rely on their oncologist to navigate this process. Acknowledging this complexity through shared decision-making may ensure that older adults have appropriate opportunities to enroll in early phase clinical trials and guard against inappropriate under-enrollment.

Development and validation of LRP1B mutation-associated prognostic model for hepatocellular carcinoma.

Purpose: To develop a lipoprotein receptor-related protein 1B (LRP1B) gene mutation-based prognostic model for hepatocellular carcinoma (HCC) patients risk prediction. Methods: The LRP1B gene mutation rate was calculated from HCC patient samples. Meanwhile, differentially expressed genes according to LRP1B mutant were screened out for prognostic model establishment. Based on this innovative model, HCC patients were categorized into high- and low-risk groups. The immune status including immune cell infiltration ratio and checkpoints have been explored in two groups. The functions of LRP1B and risk factors in the model were verified using both in vivo and in vitro experiments. Results: It could be demonstrated that LRP1B was a potential negative predictor for HCC patients prognosis with high mutation frequency. The functions of LRP1B were verified with ELISA and Quantitative Real-time PCR method based on clinic-recruited HCC participants. Eleven genes displayed significant differences according to LRP1B status, which could better predict HCC patient prognosis. The functions of these genes were examined using HCC cell line HCCLM3, suggesting they played a pivotal role in determining HCC cell proliferation and apoptosis. From the immune cell infiltration ratio analysis, there was a significant difference in the infiltration degree of seven types of immune cells and two immune checkpoints between high- and low-risk HCC patients. Conclusion: The present study hypothesized a potential prognostic biomarker and developed a novel LRP1B mutation-associated prognostic model for HCC, which provided a systematic reference for future understanding of clinical research.

Challenges in the design, conduct, analysis, and reporting in randomized clinical trial studies: A systematic review.

Background: Randomized clinical trials have been considered as the gold standard for evaluating the effectiveness and safety of medical interventions; however, there are major barriers to their design, conduct, analysis, and reporting. They are multidisciplinary and involve different steps and face a variety of challenges that may vary from one country to another. The aim of this study was to provide a comprehensive presentation of the challenges of clinical trial studies in different steps including design, conducting, analysis, and reporting. Methods: In this study, all original articles conducted during 1991-2017 that reviewed the barriers to clinical trial studies at one of the steps of design, conducing, analysis, and reporting of the results in Medline (through PubMed), Embase, Web of Sciences, Scopus, and Google Scholar were considered. The searched keywords were as follow: challenges, barriers, and randomized clinical trial. Results: The following barriers in different steps of randomized clinical trials were identified: general barriers include insufficient knowledge and understanding of clinical research and research methodology, barriers to ethical and regulatory systems, and lack of funding. The investigator-initiated trials may face similar problems to those of sponsor-initiated trials, such as handling regulatory systems, administrative and financial issues, multiple languages, and different patient compensation approaches. The challenge related to design was poor planning. Other challenges were lack of manpower and financial resources, inappropriate statistical methods for analysis (analysis challenges), and challenges related to reporting which include selective reporting. Conclusion: Based on the results of this systematic review, the most important challenges were barriers related to handling ethical and regulatory systems, patient recruitment, and lack of budget and skilled staff for conducting clinical trials. Training to improve the quality of randomized clinical trial studies in different steps and levels was the most important recommendation in these studies.

Patients' understanding of clinical research: An Italian cancer patient survey.

Patients' awareness of clinical research and their involvement in clinical trials is of great importance, but it is difficult to estimate the extent of knowledge on the research being undertaken. We evaluated the level of knowledge about clinical research using a self-reporting survey distributed to 967 adult patients with cancer attending the Departments of Medical Oncology and Onco-Haematology Units of IRST IRCCS and 4 hospitals in the region of Emilia-Romagna, Italy. The questionnaire was composed of 10 specific items on research knowledge. Patients responding correctly to at least 8 of the 10 items were considered to have a good understanding of clinical research. The questionnaire was completed by 769 patients (response rate 79.5%). Only 19% of patients were found to have a good understanding of clinical research. Patients with higher education and those who had previous clinical trial experience showed a significantly better understanding. Fifty-three percent of patients said that they would be willing to participate in a trial studying a new drug and 75% expressed an interest in taking part in informative meetings/events about clinical studies. Our results show that patients' understanding of clinical research is limited and highlight an interest in learning more.

PP-27 Survey of children and young people’s perceptions of clinical research

Background Both international declarations and some national legislation required that children and young people need to consent to participating a clinical re-search when they have the capacity to make their own decisions. However, the children and young people’s perceptions of paediatric clinical research is unknown. Fur-thermore, it is difficult to conduct a paediatric clinical trial because of enrollment difficulties. This study was con-ducted to investigate the children and young people’s perceptions of clinical trial. Methods The survey was conducted through We-Chat investigation network aged from 8–18 years. Results The effective questionnaires are 800 copies. Children and young people’s overall awareness rate of the clinical study is 40.13%. It revealed that 21% people believed that clinical research was to treat people as ex-perimental rats. When asked ‘who have the final decision on research participation’. Chose oneself, parents/guard-ian and doctor are 46.88%,74.88% and 37% respectively. When asked ‘If you want to participate a study, but your parents/guardian do not agree, what would you do?’, chose give up, persuade parents agree and unknown were 35.75%,41.00%,19.63% respectively. When asked ‘If you do not want to participate a study, but your parents/guardian thinks you should, what would you do? ‘chose listen to parents, refuse the suggestions of parents/guard-ian, unknown were 56.75%, 24.13% and 15.5.0% respec-tively. When asked’If the trial is similar to the ordinary clini-cal treatment, would you agree to participate?’, chose very willing, willing, neutral and unwilling was 10.88%, 40.88%, 27.75%, and 18.25% respectively. When asked ‘If the clin-ical research is helpful to you, but it need to draw a little more blood, do you like to participate’, chose very willing, willing, neutral and unwilling was 12.88%, 42.63%, 15.63% and 24.50%. When asked ‘If the clinical research is helpful for you, but it need to add some unpainful tests, would you like to participate?’,chose very willing, willing, neutral and unwilling were 10.13%, 39.63%, 24.25% and 23.50%. As to ‘what are your most concerns of participate an in-vestigation?’, chose ‘worry about added pain or discom-fort’ was 68.63%, chose’people treat me differently when they know me participate the research’was 11.13%. As to ‘How can reduce your concerns or make you feel better to participate the research?’, chose ‘doctors and nurses take good care of me’ was 64.00%, chose ‘get to know more about research’was 41.88%. As to‘how can encour-age you to participate an research?’, chose ‘know that other people also participate the research’ was 58.75%, chose ‘know the information after research’was 48.38%, chose ‘get economy compensation’ was 31.13%. When asked ‘If the research is not helpful for you, but it will help others, will you participate?’, chose willing and unwilling was 78.75% and 21.25% respectively. Conclusion It is very necessary to education and cor-rect guide children and young people’s understanding of clinical research. It is very necessary to concern about the children and your people who involved in the research. The situation of the paediatric clinical trial recruitment dif-ficulties could be improved by efforts.

Oncologic patients attitudes and participation in clinical trials.

e18029 Background: Clinical trials are an essential part of the oncological care. However, literature indicates low accrual of only 2-4% of the oncologic population. One of the leading known barriers is the patient's hesitant attitude toward participation. This study aimed to evaluate the patients' population treated in the Tel Aviv Sourasky Medical Center (TASMC) oncology division and their understanding of clinical research in order to improve local recruitment strategies. Methods: An observatory, questionnaire based research was conducted. Patients receiving active oncology treatment in the TASMC oncologic day care unit were asked to complete an anonymous questionnaire, which was comprised of two main parts: the first evaluate demographic information and past experience in clinical research. The second investigated basic knowledge true/false test regarding clinical trials. The questionnaire was validated by both external and internal validity tests (α-Cronbach validity test) and was approved by the local ethics committee. Results: Two hundred patients completed the questionnaires. Median age was 60. 64% would consider participating in a clinical study. 23% (N = 46) had past experience in research, and compared to those with no experience they were found to have higher academic education (67.4% vs 36.9%, p < 0.0001), be more secular (76.1% vs 58.3, p = 0.037) and to have a better understanding of medical research (84.4%, vs 36.5%, p < 0.0001). They were also more inclined to participate in a future research (73% vs 44.9%, p = 0.01). Of those who would decline to participate and had failed the knowledge test (score less than 60%), the most frequent concern was related to the placebo arm (p = 0.055), ability to reject consent, and to trust issues with the treating oncologist. Conclusions: Despite a noteworthy readiness to enroll in clinical trials among the TASMC oncologic population, there were found significant knowledge and basic understanding gaps regarding clinical trials. Further efforts are needed to better understand specific accrual barriers and to develop an adapted information system.

What advanced cancer patients with limited treatment options know about clinical research: a qualitative study.

Discussions between oncologists and advanced cancer patients (ACPs) may touch on the complex issue of clinical trial participation. Numerous initiatives have sought to improve the quality of these potentially difficult conversations. However, we have limited data about what ACPs know about clinical research as they enter such discussions as, to date, such research has focused on the period following informed consent. This study examines ACPs' understanding of clinical research in the treatment period before consent. We conducted in-depth interviews with adult ACPs with limited treatment options at four clinics in an academic medical center. So as not to influence patients' perspectives, interviewers probed patients' knowledge of clinical research only if the patient first brought up the topic. Interviews (40-60min) were audio-recorded, transcribed, and analyzed thematically and via quantitative content analysis by an interdisciplinary team. Of 78 patients recruited, 56 (72%) spontaneously brought up the topic of clinical research during interview and are included in this analysis. Qualitative thematic analysis and quantitative content analysis revealed that patients' knowledge varied in terms of (1) accuracy and (2) specificity (level of detail). ACPs who spoke with high specificity were not always accurate, and ACPs with accurate knowledge included both high- and low-specificity speakers. ACPs' knowledge of clinical research is variable. Patients who can discuss the technical details of their care may or may not understand the broader purpose and procedures of clinical trials. Understanding this variability is important for improving patient-provider communication about clinical research and supporting efforts to provide individualized care for ACPs.

Evidence-Based Strategies for Shortening Informed Consent Forms in Clinical Research.

Long informed consent forms (ICFs) remain commonplace, yet they can negatively affect potential participants' understanding of clinical research. We aimed to build consensus among six groups of key stakeholders on advancing the use of shorter ICFs in clinical research. Partnering with the HIV Prevention Trials Network (HPTN), we used a modified Delphi process with semistructured interviews and online surveys. Concerns about redundancy of information were common. Respondents supported three strategies for reducing ICF length: (a) 91% agreed or strongly agreed with grouping study procedures by frequency, (b) 91% were comfortable or very comfortable with placing supplemental information into appendices, and (c) 93% agreed or strongly agreed with listing duplicate side effects only once. Implementing these strategies will facilitate adoption of the proposed changes to U.S. regulations on ICF length, should they be enacted.

S27 - The patients' understanding of clinical research

S27 - The patients' understanding of clinical research

Educating Parents About Pediatric Research: Children and Clinical Studies Website Qualitative Evaluation.

A gap in information about pediatric clinical trials exists, and parents remain uncertain about what is involved in research studies involving children. We aimed to understand parent perspectives about pediatric clinical research after viewing the online Children and Clinical Studies (CaCS) program. Using a qualitative descriptive study design, we conducted focus groups with parents and phone interviews with physicians. Three themes emerged providing approaches to improve parent's understanding of clinical research by including strategies where parents (a) hear from parents like themselves to learn about pediatric research, (b) receive general clinical research information to complement study-specific details, and (c) are provided more information about the role of healthy child volunteers. Parents found the website a valuable tool that would help them make a decision about what it means to participate in research. This tool can assist parents, providers, and researchers by connecting general information with study-specific information.

Understanding of early-phase clinical trials among a cohort of advanced cancer patients with limited standard treatment options.

9651 Background: Early phase (EP) trials are typically offered to ACP once they exhaust standard treatment options. Limited knowledge exists about what patients understand regarding EP trials as they approach the end of standard treatments. Methods: ACP were recruited from five clinics at an academic medical center with an EP trials program. Patients were eligible if treating oncologists deemed them likely to exhaust standard treatment in 6-12 months. Eligible patients completed a 60 minute qualitative interview. Clinical research was only discussed if patients raised it during the interview. Interviews were audio recorded and transcribed; Atlas.ti was used for thematic coding. Results: 82 patients were recruited; 60 mentioned clinical research. Thematic analysis showed that understanding of clinical research differed along two dimensions: Accuracy and Specificity. Some ACP accurately described research; others had inaccurate understandings. Patients described the research process with different degrees o...

Promoting public awareness of randomised clinical trials using the media: the ‘Get Randomised’ campaign

AIMTo increase public awareness and understanding of clinical research in Scotland.METHODSA generic media campaign to raise public awareness of clinical research was launched in 2008. The ‘Get Randomised’ campaign was a Scotland-wide initiative led by the University of Dundee in collaboration with other Scottish universities. Television, radio and newspaper advertising showed leading clinical researchers, general practitioners and patients informing the public about the importance of randomised clinical trials (RCTs). ‘Get Randomised’ was the central message and interested individuals were directed to the http://www.getrandomised.org website for more information. To assess the impact of the campaign, cross-sectional surveys were conducted in representative samples of 1040 adults in Scotland prior to campaign launch and again 6 months later.RESULTSThere was an improvement in public awareness of clinical trials following the campaign; 56.7% [95% confidence interval (CI) 51.8, 61.6] of the sample recalled seeing or hearing advertising about RCTs following the campaign compared with 14.8% (10.8, 18.9) prior to the campaign launch (difference = 41.4%; 95% CI for difference 35.6, 48.3; P < 0.01). Of those who recalled the advertising, 49% felt that the main message was that people should take part more in medical research. However, on whether they would personally take part in a clinical trial if asked, there was little difference in response following the campaign [‘yes’ 31.3% (28.4, 34.1) prior; 30.4% (27.6, 33.2) following; difference =−0.9%; 95% CI for difference −4.8, 3.1%; P= 0.92].CONCLUSIONSIt is possible to raise public awareness of clinical research using the media, but further efforts may be required to influence individuals' decisions to take part in clinical research.

Identifying Preconceptions of Clinical Research in Swiss Allied Health and Nursing Researchers

Purpose: In the context of training health professionals in Switzerland in evidence-based practice, the preconceptions of active researchers might be playing a major role in the development of research methodologies within allied health and nursing professions (AHNP). The objective of this study was to identify the preconceptions (understanding of the meaning of clinical research) of researchers in AHNP at the Health Schools of the University of Applied Sciences, Western Switzerland (UASWS). Emerging theories were then discussed and challenged with available literature and participant profiles. Method: Anonymous semi-directed interviews of 20 researchers (internal and external to the university) arising from various professions, including medical and non-AHNP, were conducted between 2007 and 2008. Results: Preconceptions were grouped into eight categories that were used by 64% of participants (SD 21.8), indicating that the categories worked well in evoking participants’ preconceptions. Categories of themes covering the dimensions of clinical research definition are limits, aim, fields of professional application, professional identity, education, sensitivity of term, associated images, and relevance of a definition. Conclusion: Nurses appear to have specific preconceptions about clinical research. Due to their dominance in terms of number of professionals, they play a determining role in the development of research in AHNP in Switzerland. Researchers in the health division of the UASWS are suffering from a lack of access to experimental research and training in Switzerland. The methodological background experience of researchers seems to play a role in the understanding of clinical research, as from the available results researchers with an experimental background seem to have a larger definition of clinical research. Recommendation: authors recommend the use of the term “patient oriented clinical research” for AHNP when talking about CR.

Practice-Based Clinical Research and Ethical Decision Making-Part I: Deciding Whether to Incorporate Practice-Based Research into Your Clinical Practice

Calls for increasing clinical research in routine care settings aim to improve the empirical and ethical foundations of evidence-based practice. In the treatment and prevention of stroke many troubling management questions remain uninvestigated by the clinical research enterprise. Many practicing physicians perceive available data as having limited applicability to their average patients. Recent efforts by the National Institute of Neurological Disorders and Stroke seek to establish clinical research networks that will expand the role of private practice physicians in the conduct of research on stroke and other neurological diseases, akin to practice-based research networks supported by the Agency for Healthcare Research and Quality and other National Institutes of Health institutes. Adding clinical research to one's practice of medicine has practical and ethical implications. Furthermore, because of the growth and expansion of clinical research, all practicing physicians should have a fundamental understanding of clinical research and the differences between clinical care and clinical research, even if they are not directly involved in the conduct of clinical research, to appropriately advise their patients. In this and the following article, we offer two practical frameworks to aid physicians contemplating adding clinical research to their everyday practice of medicine.

Studying the treatment of chronic hepatitis B viral infection in special populations.

There are estimated to be more than 400 million people chronically infected with the hepatitis B virus (HBV) worldwide (Fig. 1) (1). At least 20–30% of those chronically infected will die of complications of chronic liver disease including cirrhosis and liver cancer (2,3). The World Health Organization (WHO) places HBV in the top 10 causes of death worldwide (4). The estimated viral burden in the United States is 1.5 million people, with disease concentrated in ethnic subgroups and populations with high-risk behavior, and health care costs to the North American economy that exceed $350 million per year. Although the United States is considered an area of low-prevalence hepatitis B infection, the incidence of new cases, the prevalence of carriers, and the burden of acute and chronic disease maintain hepatitis B high among the important communicable diseases. It is estimated that 300,000 new cases of hepatitis B infection occurred each year in the United States in the 1970s and 1980s. Currently about 125,000 new cases occur each year in North America. These acute infections have led to at least 27,000–42,000 chronic carriers, 17,000 hospitalizations, 300 cases of fulminant liver failure, and ultimately 4000–5500 deaths per year in the United States from cirrhosis and primary liver cancer as well as the morbidity and cost of liver transplantation in approx 350 patients per year (5–11). The age-specific incidence of acute HBV infection is shown in Fig. 2. The risk of developing chronic HBV infection after acute exposure ranges from 1% to 5% for adults and 90% for infants born to infected mothers (Fig. 3). Once chronic infection has occurred, a heterogeneous group of patients or clinical profiles is evident based on a combination of viral replication, fibrosis progression, host immune response, and presence or evolution of viral mutants. The understanding of clinical research targeted at special subsets of HBV-infected patients is essential to study design and the interpretation of the clinical literature. The purpose of this chapter