Clinical Research Knowledge Research Articles

A Proposed Framework for Rigor and Transparency in Dysphagia Research: Prologue.

Scientific transparency and rigor are essential for the successful translation of knowledge in clinical research. However, the field of oropharyngeal dysphagia research lacks guidelines for methodological design and reporting, hindering accurate interpretation and replication. This article introduces the Framework for RigOr aNd Transparency In REseaRch on Swallowing (FRONTIERS), a new critical appraisal tool intended to support optimal study design and results reporting. The purpose of introducing FRONTIERS at this early phase is to invite pilot use of the tool and open commentary. FRONTIERS was developed by collaborating researchers and trainees from six international dysphagia research labs. Eight domains were identified, related to study design, swallowing assessment methods, and oropharyngeal dysphagia intervention reporting. Small groups generated questions capturing rigor and transparency for each domain, based on examples from the literature. An iterative consensus process informed the refinement and organization of primary and subquestions, culminating in the current initial version of FRONTIERS. FRONTIERS is a novel tool, intended for use by oropharyngeal dysphagia researchers and research consumers across disciplines. A web application enables provisional use of the tool, and an accompanying survey solicits feedback regarding the framework. FRONTIERS seeks to foster rigor and transparency in the design and reporting of oropharyngeal dysphagia research. We encourage provisional use and invite user feedback. A future expert consensus review is planned to incorporate feedback. By promoting scientific rigor and transparency, we hope that FRONTIERS will support evidence-based practice and contribute to improved health outcomes for individuals with oropharyngeal dysphagia.

120 Impact of Undergraduate Clinical Research Experience: Highlighting the UCLA Clinical and Translational Science Institute Research Associates Program (CTSI-RAP)

OBJECTIVES/GOALS: CTSI-RAP is a professional development program that provides undergraduate students with clinical research exposure and training. Students support UCLA research faculty by assisting with all aspects of the research process, including recruiting participants, data management, and presentations. METHODS/STUDY POPULATION: CTSI-RAP onboards a 15-20 volunteer student cohort annually in a competitive application and interview process with less than a 10% acceptance rate. Since the inaugural cohort in 2013, over 160 students have participated. The program engages hundreds of students each year through the recruitment process, campus clinical research events, and student-led conference opportunities. Evaluation surveys developed through REDCap in 2022 sought to assess the program’s impact on undergraduate experiences, professional development, and post-graduate careers. Surveys distributed to investigators and their study teams evaluated the student’s clinical research knowledge and engaged student involvement. RESULTS/ANTICIPATED RESULTS: Based on evaluation surveys, the CTSI-RAP program received excellent reviews from both students and their assigned study teams. 100% of students and faculty would recommend the program to a friend or colleague. 30% of students present or publish annually, indicating a wealth of meaningful contributions made by students. 90% of students go on to attend medical school, health-related graduate school, or other health-related employment. Several students continue working in clinical research through gap-year employment. As demonstrated by the high caliber of student and faculty experiences, CTSI-RAP has created an esteemed and valued symbiotic infrastructure to support clinical research endeavors at UCLA. DISCUSSION/SIGNIFICANCE: Through clinical research career exploration and professional skill-building in undergraduate careers, the CTSI-RAP program produces highly-trained future leaders in the field and benefits the capacity of UCLA research. CTSI-RAP provides a model for similar programs to be funded and implemented in other institutions.

Knowledge and engagement in research activities by medical students: challenges and new opportunities - an institutional survey.

Objectives: to describe participation and knowledge in research programs by medical students from Oswaldo Aranha University Center (Centro Universitário Fundação Osvaldo Aranha, UNIFOA). Methods: it was applied a survey during 2nd Symposium on Clinical Research - focusing on oncology in the South of the State of Rio de Janeiro. The survey was answered by medical students from UNIFOA, encompassing socio-demographic variables, and clinical issues. Results: 73 participants answered the survey, 64.4% (47/73) of them registered up to 3rd semester. Regarding participation in academic research project, 79.5% (67/73) didn’t have any participation, more than fifty per cent 56.2% (41/73), tried to participate in a project, but only 23.3% (17/73) got success in this initiative. Concerning general knowledge in clinical research, 80.8% (59/73) affirmed not had any contact with theme up to moment in their graduation course. Questions evaluating knowledge in basic concepts, described that only 50.7% (37/73) of the students know the difference between basic and clinical research, and only 45.2% (33/73) know the steps of approval process involving medical procedures. Conclusion: low engagement of medical students in research activities might explain the low rate of physicians working on this area. Their potential interest should be enabled by medical schools to increase qualified human resources which will accelerate Brazilian participation in clinical trials.

Digital badges in academia: An educational tool for the clinical research coordinator.

Digital badges can provide condensed competency-based knowledge enabling individuals a chance to explore specialized careers in clinical research. A digital badge can be an efficient pathway to introduce clinical research job roles and educate a larger diverse workforce for clinical research coordinator positions at AMCs. The New Jersey Alliance for Clinical and Translational Science (NJ ACTS) developed a digital badge with potential to broaden exposure to training opportunities for CRCs and improve their prospects for a career at Rutgers. This paper describes the development of a digital badge introducing individuals to the clinical research profession, especially for those who aspire to become a CRC. The badge was designed to include five domains (Scientific Concepts and Research Design, Ethical and Participant Safety Considerations, Clinical Study Operations and Site Management, and Data Management and Informatics). Participants assessed the badge for accuracy and presentation level. The results demonstrated that the competencies were met, and content was appropriate for someone with limited knowledge of clinical research. Survey results along with the Difficulty Index and Discrimination Index calculated for quiz questions supported the badge rank as foundational. Research is ongoing to evaluate the value of the badge to job acquisition, performance, and career growth.

To explore clinical pharmacists’ opinions, and their perceived barriers and facilitators, to supporting clinical research delivery in secondary care

Abstract Introduction The National Health Service (NHS) is confronted with significant challenges in facilitating clinical research delivery.1 Clinical pharmacists were instrumental in ensuring patient safety while conducting urgent public health studies, such as the RECOVERY trial, during the COVID-19 pandemic.2 Numerous studies have reported the positive impact of pharmacy workforce in supporting clinical research delivery3. However, it remains unclear whether pharmacists are willing to take on this extra responsibility. Aim To explore the opinions of UK clinical pharmacists towards facilitating the delivery of clinical research in secondary care. Objectives include understanding the level of knowledge of clinical research among clinical pharmacists; assessing levels of interest among clinical pharmacists towards supporting clinical research delivery; identifying clinical pharmacists’ perceived barriers and facilitators to supporting clinical research delivery; and developing recommendations to facilitate pharmacists’ engagement in research delivery. Methods This study employed a qualitative research approach and utilised convenience sampling based on the researcher’s professional network. Eight pharmacists from two secondary care NHS Trusts participated. Individual semi-structured interviews were conducted using questions adapted from the Research Capacity and Culture (RCC) tool which was validated by two clinical trial pharmacists. Keele University Research Ethics Committee provided a favourable ethical opinion. Interview transcripts were analysed to identify emerging themes by using framework analysis. Results The findings revealed that participants possessed limited knowledge of clinical research in general. The key themes identified were categorised into three domains: individual, professional, and organisational, which corresponded with the RCC tool. In the individual domain, pharmacists demonstrated interest in clinical research delivery but lacked confidence. They acknowledged clinical research as contributing to evidence-based practice and enhancing professional development. However, they expressed concerns about patient harm resulting from trial interventions and poorly designed studies generating misleading data. Within the professional domain, pharmacists' capability to support clinical research delivery was limited by inadequate training in clinical research, their clinical skills, and their disease knowledge. They perceived internal and external barriers to participation. It has been suggested to improve the research culture within the profession and promote the role pharmacists can play in delivering research among other healthcare professionals. In the organisational domain, the workplace environment was perceived to present obstacles due to competing priorities and clinical research not being seen to be a core duty by managers. Additionally, awareness of clinical research opportunities was limited and exposure to clinical research-related activities within the workplace was minimal. Discussion/Conclusion Recommendations to address these barriers include promoting clinical research training, developing mentorship programs, creating platforms to connect clinical pharmacists with research opportunities, and identifying roles that allow pharmacists to incorporate clinical research into their routine practice. This research project has several limitations, including the use of a convenience sampling method, a small sample size and potential interviewer bias due to research participants all being known to the researcher. In summary, the pharmacy workforce possesses the potential to support the challenges in clinical research delivery faced by the NHS. However, addressing the perceived barriers is critical to enhancing pharmacist involvement in this field.

Attitudes and barriers to participation in window-of-opportunity trials reported by White and Asian/Asian British ethnicity patients who have undergone treatment for endometrial cancer

PurposeWindow-of-opportunity trials (WOT) are a study design that have been used to investigate drug activity in endometrial cancer (EC). Recruitment to cancer clinical trials by patients from ethnic minority groups is reported to be lower than for patients of White ethnicity.MethodsA verbal questionnaire was conducted with White and Asian/Asian British ethnicity patients who had undergone treatment for EC. Strategic purposeful sampling was used to recruit patients from diverse social/educational backgrounds. Questions explored: background knowledge of clinical research, WOT study design, and views on medications that might be investigated. Thematic analysis was used to explore motivations for WOT participation and perceived barriers.ResultsIn total, 21 patients were recruited to the study (15 White and 6 Asian/Asian British). Views on optimum time to receive trial information differed, preferences ranging from 'at the time of diagnosis' to 'a few days after diagnosis'. The choice of medication under investigation had a strong influence on potential willingness to participate, with greater interest reported in medications derived from vitamins or food supplements rather than hormone-based drugs. Potential barriers to participation included concern over potential side-effects and the emotional/physical burden of a cancer diagnosis prior to major surgery.DiscussionThis study provides important insights into patients’ views on WOT participation in EC and raises issues that need to be considered for future trial design and participant recruitment materials. The timing and format of study information and type of substance under investigation were factors influencing potential participation. Future studies should consider using multi-lingual visual information videos to address information needs, as this may encourage participation by ethnic minority patients.

Reconceptualizing Integrated Knowledge Translation goals: a case study on basic and clinical science investigating the causes and consequences of food allergy

BackgroundIntegrated Knowledge Translation (IKT) and other forms of research co-production are increasingly recognized as valuable approaches to knowledge creation as a way to better facilitate the implementation of scientific findings. However, the nature of some scientific work can preclude direct knowledge to action as a likely outcome. Do IKT approaches have value in such cases?MethodsThis study used a qualitative case study approach to better understand the function of IKT in a non-traditional application: basic and clinical science investigating the causes and consequences of food allergy. Building off previous baseline findings, data were obtained through in-depth interviews with project scientists and steering committee members and complemented by researcher observation. Data were analyzed through an integrated approach to understand how well participants perceived the stipulated project IKT outcomes had been met and to better understand the relationship between different forms of IKT goals, outcomes, and impacts.ResultsWe propose a conceptual model which builds temporal continuity into the IKT work and understands success beyond truncated timelines of any one project. The model proposes project IKT goals be conceptualized through three metaphorical tower blocks: foundational (changing the culture for both scientists and knowledge-users), laying the groundwork (building relationships, networks and sparking scientific inquiry), and putting scientific knowledge to action. Based on this model, this case study demonstrated notable success at the foundational and intermediate blocks, though did not turn basic and clinical research knowledge into actionable outcomes within the project timespan.ConclusionsWe find that current IKT literature which situates success as filling a knowledge to action gap is conceptually inadequate for understanding the full contributions of IKT activities. This work highlights the need for building cultural and scientific familiarity with IKT in order to better enable knowledge to action translation. Improving understanding and communication of science and empowering knowledge-users to engage with the research agenda are long-term strategies to build towards knowledge implementation and lay the ground work for many future research projects.

Clinical Trials and Clinical Research: A Comprehensive Review.

Clinical research is an alternative terminology used to describe medical research. Clinical research involves people, and it is generally carried out to evaluate the efficacy of a therapeutic drug, a medical/surgical procedure, or a device as a part of treatment and patient management. Moreover, any research that evaluates the aspects of a disease like the symptoms, risk factors, and pathophysiology, among others may be termed clinical research. However, clinical trials are those studies that assessthe potential of a therapeutic drug/device in the management, control, and prevention of disease. In view of the increasing incidences of both communicable and non-communicable diseases, and especially after the effects that Coronavirus Disease-19 (COVID-19) had on public health worldwide, the emphasis on clinical research assumes extremely essential. The knowledge of clinical research will facilitate the discovery of drugs, devices, and vaccines, thereby improving preparedness during public health emergencies. Therefore, in this review, we comprehensively describe the critical elements of clinical research that include clinical trial phases, types, and designs of clinical trials, operations of trial, audit, and management, and ethical concerns.

A cross-sectional survey on principal investigators' clinical research knowledge in Japan.

Principal investigators (PIs) play a key role in clinical research, and must thus understand the role of clinical research support staff to conduct successful and appropriate clinical research. This study evaluates clinical research capabilities by examining the clinical research knowledge of PIs and clinical research support staff. The participants of this cross-sectional study were academic researchers and clinical research support staff from Japanese universities and research institutions. The participants comprised of 54 respondents, among whom 36 were PIs (physicians) and 18 were clinical research support staff. A self-administered electronic survey was created and evaluated by experts, with 50 knowledge items. Mann-Whitney U tests were used to determine the significance of the differences in knowledge between clinical research support staff and PIs. We compared the correct answer rate of clinical research support staff and PIs for each knowledge category and observed that the clinical research support staff scored significantly higher than the PIs in all aspects of clinical research knowledge sections, including total score. Our findings showed that PIs did not have the same amount of clinical research knowledge as the clinical research support staff. Clinical research knowledge is essential for investigators, especially PIs, to protect patients and promote medical breakthroughs. Thus, more accessible clinical research education and mandatory knowledge testing will allow PIs to lead successful clinical research and further the level of medical research in Japan.

SNMMI Clinical Trials Network Research Series for Technologists: Clinical Research Primer—Regulatory Process, Part I: How and When Radiopharmaceuticals Can Be Used

CE credit: For CE credit, you can access the test for this article, as well as additional JNMT CE tests, online at https://www.snmmilearningcenter.org Complete the test online no later than March 2025. Your online test will be scored immediately. You may make 3 attempts to pass the test and must answer 75% of the questions correctly to receive Continuing Education Hour (CEH) credit. Credit amounts can be found in the SNMMI Learning Center Activity. SNMMI members will have their CEH credit added to their VOICE transcript automatically; nonmembers will be able to print out a CE certificate upon successfully completing the test. The online test is free to SNMMI members; nonmembers must pay $15.00 by credit card when logging onto the website to take the test.The radiopharmaceutical development and approval process in the United States has changed dramatically over the past decade with the emergence of several new and exciting diagnostic and therapeutic drugs. This impressive expansion is a direct result of the symbiotic relationship that exists between drug development, clinical research, and improved regulatory guidance. The correlative increase in clinical research has introduced diverse opportunities for newcomers in medical and scientific professions. Knowing how to successfully navigate the clinical research process can be challenging for a novice. The pathway is highly regulated and, with the addition of radiopharmaceuticals, may be confusing and daunting. Moreover, very little clinical research education and training is provided in the typical collegiate curricula for these new initiates. This article will familiarize the reader with the U.S. regulatory process by providing basic definitions and understanding of how and when radiopharmaceuticals can be used in clinical research, including those involving investigational new drug applications and radioactive drug research committees. A later article will expand the reader's clinical research knowledge by focusing on the identity and role of the institutional review board.

Greater Awareness and Knowledge of Clinical Research Increases Willingness to Participate in Future Vaccine TrialsAn Examination of the Enduring Impact of COVID-19 Pandemic

The devastating impact of COVID-19 pandemic, its fast-tracked vaccines and authorized treatments have led to more volunteers signing up to be part of clinical studies than any time in recent history. We sought to investigate the relationship between increased knowledge of vaccine clinical trials and willingness to participate in future vaccine trials. A convenience sample survey of the United States residents was conducted in May 2021. Over 1,100 adults completed questions about their knowledge of clinical vaccine trials and attitudes toward participation in future trials. A total of 1149 respondents completed the survey. The median age was 29. Amongst respondents, 47.9% were women. Over 85% had attended college. Most were married (60.1%). A significant proportion of respondents were of Hispanic origin (42.2%). Higher Knowledge Scores were observed for female respondents (p <0.001);>30 years-old respondents (p <0.001) and respondents with a bachelors’ degree or higher (p <0.05). Overall, the survey respondents felt that their COVID-19 pandemic experience had increased their knowledge of vaccine trials (807, 70.2%) and willingness to participate in future vaccine studies (677, 58.9%). In addition, over half of the respondents expressed willingness to sign up for a future vaccine study of any kind (51.5%) with another 38.0% willing to consider it. The findings from this survey confirms significant increased interest in clinical vaccine study participation in the midst of COVID-19 pandemic and provides actionable insights to improve outreach efforts with underrepresented populations in clinical research. Keywords: COVID-19; Clinical Trials Participat

Exploring network dynamics in science: the formation of ties to knowledge translators in clinical research

From an evolutionary economics perspective, knowledge networks are self-organizing systems. Therefore, studying changes of these systems requires an understanding of how such changes are influenced by both the behaviors and characteristics of key individual actors and the network structure. We apply this perspective to a network of investigators (i.e. lead scientists) and a sample of 9543 Phase 2 cancer clinical trials during the period 2002–2012, in order to examine the structure and explore the dynamics of the clinical trial network. Using temporal exponential random graph models, we examine whether preferential attachment, multi-connectivity, or homophily drive the formation of new collaborative relations to knowledge translators - i.e. investigators with basic and clinical research knowledge. Our results suggest that despite some increased connectivity over time the network remains fragmented due to the considerably growing number of investigators in the network. This fragmentation limits opportunities for knowledge transfer to advance clinical trials. We find that homophily in research fields and investigators’ country of affiliation and heterophily in terms of publication output promote the formation of ties to knowledge translators. We find also that multi-connectivity increases the probability of tie formation with knowledge translators while preferential attachment reduces this probability.

Analyzability of newly developed/commercially promoted drugs among young medical and dental doctors.

Introduction:The development of a new chemical entity into a drug is of indispensable importance for the progression of health care. As physicians play the main and important part of any clinical trial, it is necessary to know about their awareness about clinical research, drug development, good clinical practices, and regulatory authorities.Objective:This study was designed to assess and compare the knowledge and awareness toward drug development process among medical interns, dental interns, and postgraduates (PGs).Methodology:This was a cross-sectional study enrolling 186 professionals of medical college and 110 professionals of dental college in Punjab who were given a prevalidated questionnaire that included 27 questions related to knowledge regarding drug development process. Data were analyzed for percentage correct responses, mean values, and intergroup comparison by applying t-test using SPSS version 20, IBM SPSS Statistics for Windows, Version 20.0. IBM Corp., Armonk, NY, USA.Results:It was found that medical and dental college professionals had a very poor awareness and knowledge about drug development process to the tune of 33%. Professionals of dental college had 53.7% knowledge of clinical research in comparison to 43.2% of medical college. A statistically significant (P < 0.05) difference for sections on drug development, clinical research, and regulatory authority among interns and PGs was found with interns possessing better knowledge.Conclusion:It is concluded that regulatory authorities such as Board of Studies of various medical universities, Dental Council of India, and Medical Council of India must take necessary steps to increase the knowledge of drug development process among dental and medical professionals. Incorporation of this topic in educational curriculum in the initial stages of graduation and postgraduation would be beneficial.

Awareness and attitude of Saudi cancer patients toward participation in clinical research

&lt;p class="abstract"&gt;&lt;strong&gt;Background:&lt;/strong&gt; Public awareness about the importance of clinical research (CR) is crucial for patient’s participation in clinical trials. Their enrollment may be impacted by their levels of awareness and attitudes toward participation. Our study aimed to assess the Saudi cancer patient’s knowledge and perception about CR, and determine the influencing factors and barriers affecting participation.&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Methods:&lt;/strong&gt; A cross-sectional study was conducted in 300 cancer patients attending the Oncology Department at King AbdulAziz Medical City (KAMC) Riyadh between February 2011 and February 2012 using a survey covering the demographic data, knowledge of clinical research, and attitude toward participation; followed by statistical analysis.&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Results:&lt;/strong&gt; A total of 300 patients were enrolled in the study with a median age of 53.6 (42.2-64.01); 62.67% of which were females. The majority of patients (97.31%) were not aware of Institutional Review Board (IRB). However, (75.33%) showed interest in CR participation, if offered. The advanced disease (86.67%), and the lack of other treatment options (85.33%) were the top two encouraging factors, while fear of adverse side effects (58.33%), and the unknown efficacy of treatment (58.32%) were the top two barriers against participation. Respondents younger than 45 years, and educated ones were significantly more interested in participation in CR with P values P=0.0136 and P=0.0239 respectively.&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;There is an apparent gap in cancer patient’s awareness about CR. However, there is an obvious interest in participation in CR especially in younger and educated patients. Enhancing public awareness is crucial to improve participation in CR.&lt;/p&gt;

Pharmacy Students' Knowledge and Attitude toward Registration Trials and Clinical Research: A Survey in a Japanese University Hospital.

Clinical research plays a fundamental role in establishing new treatments. Clinical research coordinators are considered essential in clinical research, and medical professionals such as pharmacists often take on this role. Pharmacy students can be considered future candidates for this task. We used questionnaires to survey the knowledge of and attitudes toward registration trials and clinical research of pharmacy students at Tokushima University Hospital. All pharmacy students (103) to whom questionnaires were sent responded. Almost all respondents were aware of registration trials and clinical research. More than 90% were aware of the existence of clinical research coordinators, and about half (48.6%) understood their role. In clinical research terminology, most respondents were aware of informed consent and related issues, but fewer than 20% were aware of more practical things. In total, 29.1% and 40.8% of the respondents were willing to carry out and coordinate research. These findings suggest that pharmacy students have basic knowledge of clinical research and that many students are willing to carry out and coordinate clinical research. More practical exposure to clinical research may help to strengthen their future contribution. Further studies may help to determine how to provide education on registration trials and clinical research to pharmacy students.

A Survey on Clinical Research Training Status and Needs in Public Hospitals from Shenzhen

Objective: To obtain information on the current clinical research training status and evaluate the training needs comprehensively for medical staff in hospitals.Methods: This survey was initiated and conducted by the Health and Family Planning Commission of Shenzhen in conjunction with the Peking University Clinical Research Institute (Shenzhen) from Sep 2016 through Nov 2016. It was planned that no less than 10% of the total staff from each participating hospital were invited to complete the survey. All participants filled out the questionnaire anonymously and voluntarily.Results: A total of 644 subjects from 12 hospitals completed the survey with the response rate of 28.7%. The majority of respondents (80%) have attended training related to clinical research knowledge and skills, however, medical research ethical aspects and statistics knowledge have been provided only for 40% and 27% of respondents, respectively. With regard to preference on training subjects and contents, Protocol design and development (74%) is ranked first, followed by the data analysis and summary (59%) among those researchers from medical professions. Project management and quality control course are mostly demanded for technicians and nurses (53%). Unpredictably, no more than 40% of the respondents consider that it is necessary to receive “Regulation and Research ethics” course even for those Principal investigators.Conclusions: Our survey results indicated that training subjects on protocol design and research ethics are urgently needed and relatively inadequate in China. An appropriate clinical research competency training model should be developed and provided for hospital staffs in China.

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.

PD-8-1 - Learn more, Go further at the Pharmaceuticals and Medical Devices Agency (PMDA)

In 2013, I joined PMDA where I have been engaged in the regulatory review process for new oncology products as a part of a multidisciplinary team. In this role, I also offer advisory services for clinical trials that support new drug applications (NDAs). My responsibilities at PMDA have utilized my background in medical oncology. My particular mission is ‘smart regulation' and the purpose is to deliver effective drugs to cancer patients with a great degree of safety and without unnecessary delay. With this mission in mind, I am continuing to learn by collaborating with my professional colleagues at PMDA and other regulatory authorities (FDA, EMA, Health Canada, TGA etc.), which enables me to acquire a more comprehensive knowledge of clinical research and a broader international perspective. As a global bridge between academia, industry and regulatory officials, I want to demonstrate PMDA's essential role in advancing innovative medical solutions to benefit cancer patients worldwide.

Clinical nursing and midwifery research: grey literature in African countries.

This study reviewed grey literature to assess clinical nursing and midwifery research conducted in southern and eastern African countries over the past decade. The shortage of published nursing research from African countries severely limits the ability of practicing nurses and midwives to base clinical decisions on solid evidence. However, little is known regarding unpublished or unindexed clinical research ('grey literature'), a potentially rich source of information. Identifying these sources may reveal resources to assist nurses in providing evidence-based care. This scoping review of grey literature on clinical nursing and midwifery research in southern and eastern African countries helped to identify gaps in research and assess whether these gaps differ from published research. Systematic searches of grey literature were performed. Research was included if it was conducted by nurses in 1 of 25 southern or eastern African countries, between 2004 and 2014 and included patient outcomes. Data were extracted on location, institution, research topic, institutional connections and author information. Chi-square tests were performed to compare differences between indexed and non-indexed literature. We found 262 studies by 287 authors from 17 southern and eastern African countries covering 13 topics. Although all topics were also found in indexed literature and there were statistically significant differences between the number of times, fewer topics were covered in grey literature vs. indexed. Patient satisfaction and experience and traditional health practices were more likely to be published, whereas chronic disease, assault and paediatric-related research were less often published. Generally, there is a paucity of clinical nursing research in this region. This could reflect the shortage of nurses prepared to conduct research in this region. Nurses may find additional resources for evidence in the grey literature. A complete understanding of the state of nursing science in southern and eastern African countries will help nurses and midwives to understand gaps in clinical research knowledge, potentially direct their research to more critical topics, and inform funding bodies and policy-makers of the situation of nursing science in southern and eastern African countries.

Importance of Clinical Research Training to Nurses’ for Wider Roles in Clinical Research: A Survey Based Study

It has been observed that nurses play a great role in clinical studies with their limited and routine training background of nursing. Clinical research includes a vast number of clinical trials and short term studies that are taken over by different research groups from time to time. It is matter of fact that mostly physicians are the principal investigators for clinical trials and by default regulatory authorities also recommend a great contribution of physicians in such studies. It is also pertinent to mention here that physicians/ principal investigators have limited time and practically devote lesser time for these studies. At the same time contribution of nurses attached in the clinical trial/study cannot be overlooked despite lack of any scheduled training to them for clinical research. A survey was conducted in nursing colleges, reputed multi-speciality hospitals to know about the awareness of nurses at different levels working in Govt hospitals, private hospitals, post graduate students, and undergraduate nurses. A questionnaire was developed for this survey. The data shows that even M.Sc. nursing students are having a Clinical research knowledge index of only about 75% as compared to staff nurses with significantly less Clinical research knowledge index (57%) about clinical research. The study reflects certain barriers like poor lack of focussed training, knowledge of technical skills, lack of communicating skills, lack of authority to make change, poor multi-professional team work, and lack of resources and heavy work load resulting in a poor performance and deprived efficiency of nursing graduates in research projects. This study also highlights the better focussed role of nurses in clinical research after a clinical research training course. Keywords : Clinical Research Knowledge Index; Survey; Nurses; Importance of Training