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Call for Chapters
A Comprehensive Guide for Novice Researchers in Clinical Trials
Elsevier, Academic Press Imprint
Series: Next Generation Technology Driven Personalized Medicine and Smart Healthcare
For more information on the series, visit Next Generation Technology Driven Personalized Medicine.
Call for Chapters
Introduction to the Theme
The landscape of clinical trials is evolving rapidly, with increasing emphasis on personalized medicine, innovative methodologies, and technology-driven approaches. This book, A Comprehensive Guide for Novice Researchers in Clinical Trials, aims to provide an accessible, in-depth foundation for early-stage researchers and professionals in the field. Topics include research methods, trial design, ethics, data management, and regulatory insights specific to Saudi Arabia. The objective is to create a resource that bridges theoretical foundations with practical applications in clinical trials, addressing the needs of today’s healthcare researchers.
Objectives of the Book
This book is designed to:
- Equip novice researchers with a comprehensive understanding of clinical trial methodologies and requirements.
- Introduce essential aspects of clinical research, from trial design to data management, while highlighting ethics and regulatory practices.
- Serve as a Scopus-indexed reference that leverages Elsevier’s ELSA platform, making it accessible to a broad academic and professional audience.
Table of Indicative Chapters
- Introduction to Health Research Methods
- History of Clinical Trials
- Clinical Trial Designs
- Clinical Trial Essentials
- Ethics and Good Clinical Practice in Clinical Trials
- Trial Protocol Development
- Clinical Research Site Operation
- Clinical Data Management
- Clinical Trial Monitoring
- Principles of Statistics in Clinical Trials
- Reporting Clinical Trials
- Essentials of Project Management
- Regulatory Affairs of Clinical Trials in Saudi Arabia
- Training Programs and Job Opportunities in the Clinical Trial Industry
Important Guidelines for Contributors
- Submission Platform: Contributions will be managed through Elsevier’s ELSA platform.
- Proposal Submission: A chapter proposal (300-500 words) is required for initial review. Detailed guidelines for authors, a sample chapter, and sample chapter abstract are attached for reference.
- Manuscript Preparation: Use MS Word with consistent formatting (bold, font size) for different heading levels. Each chapter should contain an abstract (100-150 words) and 5-10 keywords. Refer to the Elsevier Manuscript Preparation Guidelines for specific formatting instructions.
- Artwork and Figures: Figures and tables should be submitted separately, with high-resolution images in JPG or TIFF format as per the provided guidelines.
- Permissions: Contributors are responsible for obtaining permissions for any third-party material. An artwork list detailing all figures and tables with appropriate permissions is required upon manuscript submission.
- Language and Style: Both British and US English are acceptable; however, authors must remain consistent within their chapters.
- Reference Style: Use either the Harvard (Name-Date) or Vancouver (Numbered) style, as outlined in the guidelines.
Timeline
- Submission of Chapter Proposals (300-500 words): December 5, 2024
- Acceptance of Book Chapter Proposals: December 10, 2024
- Full Chapters Due: February 15, 2025
- Reviews to Authors: March 5, 2025
- Final Chapters to ELSA: April 1, 2025
- Publication: Quarter 4, 2025
Editorial and Contact Information
Editors
- Dr. Basim Alsaywid Saudi National Institute of Health, Riyadh, Saudi Arabia Email: balsaywid@snih.gov.sa
- Dr. Miltiadis D. Lytras Saudi National Institute of Health, Riyadh, Saudi Arabia Email: miltiadis.lytras@gmail.com
Managing Editor
- Dimitrios Lytras, MD Student School of Medicine, National Kapodistrian University of Athens Email: dimitrios.lytras.md@gmail.com
For further information, please refer to the attached author guidelines, sample chapters, and sample abstract. We look forward to receiving your proposals and contributions to this impactful project.
This is the email sent Oct 1st at 3pm:
Parul from Zydaptive just sent you a full-text request for:Impact of Fibromyalgia Severity on Health Economic Costs
ArticleApplied Health Economics and Health Policy 03/2011; 9(2):125-36., DOI:10.2165/11535250-000000000-00000
Andreas Winkelmann · Serge Perrot · Caroline Schaefer · Kellie Ryan
See request
Broad and narrow determinants of health policy
The protocol should indicate how the study will contribute to advancement of knowledge ,how the results will be utilized ,not only in the publications but also how they will likely affect the health care ,health systems and health policies.
I am a student of public policy studying the policy cycle. I am curious about the potential role of citizens within this cycle as well as critique about the current situation I am writing from New Zealand, interested in health policy and also issues regarding the Treaty of Waitangi
Anybody got invited to submit his/her article to OPAST group? I recently received several emails from this network of OPAST journals (e.g. International Journal of Health Policy Planning), and I could not verify the reputation yet. Is there anyone with any knowledge about this so far? Thank you for the attention.
I'm currently seeking individuals who would be open to participating in a brief interview or responding to a questionnaire through a Google Form for my thesis research, which focuses on evaluating the governance system of the healthcare sector in the UAE. I've utilized LinkedIn, email, and even made in-person visits to the Ministry of Health in my efforts to reach out to relevant professionals. Unfortunately, the response rate has been quite low.
I would greatly appreciate any suggestions or guidance you may have on more effective ways to connect with individuals working in sectors related to Health in the United Arab Emirates. Your insights and recommendations would be incredibly valuable to my research. Thank you in advance for your assistance.
How do you really measure the Impact of enacting a Health Policy on the community? for example, increasing tax on packet cigarette
The IPBES assessment "Options for delivering sustainable approaches to health” is looking for examples where programs and policies have included indigenous and local knowledge. If you know some examples even are not fully documented your contribution will be appreciated.
(Add your answers in english, spanish, or french).
Thanks
I am currently doing research around mental health in the workplace and I aim to send out two questionnaires. One for line managers/HR staff and the other questionnaire to employees. My research is focused on the managers and also employee opinions, attitudes and perceptions of mental health and well-being in the workplace. so my questions are around how do employees rate their mental health policies and procedures including support programs and services available to them.
Within my surveys I am using likert scales and also open-ended questions. I plan on using thematical analysis for the qualitative part and SPSS for the likert rating scale questions.
I was just wondering if you have any guidance or tips on this?
Any help would be greatly appreciated?
Thank you
What do you consider to be the main methodological approaches to answering key questions in health policies?
Dear Colleagues,
With an increasing number of countries implementing digital health and digital public health tools, questions arise about whether these tools are effective and how to implement them best nationally. The lack of a validated and standard list of indicators complicates the comparison of digital health maturity between countries. We need guidance for governments in setting up strategies for the effective implementation and adoption of digital public health tools in routine care and the prevention of diseases.
To address this challenge, we want to invite researchers and practitioners from medicine, public health, economics, computer science, law, cultural studies, sociology, or other comparable disciplines. Participants should know about the development, implementation and evaluation of digital public health systems to take part in a Delphi study to choose the leading quality indicators to assess the maturity of national digital public health systems from four perspectives:
1. The information-telecommunication-technology requirements
2. The political support and legal regulation for the implementation and use of health technologies and the generated data
3. The application of concrete digital health tools to the national health system
4. The collective social willingness to use these tools
We are using a snowball approach to reach as many experts as possible. Please join our effort by participating in this Delphi study https://bit.ly/3raMsVY. Please forward this message to all your mailing lists of colleagues that might fit the purpose of this study. Every participation will be greatly appreciated and contribute to a better understanding of international digital public health systems.
This Delphi study will be conducted within the German Leibniz ScienceCampus Digital Public Health research project entitled "Developing a Maturity Measurement Model for Digital Public Health: The Digital Public Health Readiness Index".
Best regards and take care,
Laura Maaß
(on behalf of the digital public health readiness index team and the EUPHA Digital Health Section)
Link to Survey: https://bit.ly/3raMsVY
I will be doing a study where I will compare the health policies of two countries. Is normative comparison a good way to go about it? If not how can I analyse my data?
Thanks in advance
Kind regards
Lavinia
Looking for help with jurisprudential research in health policy with potential impact on clinical trial data disclosure; would involve interpretation and analysis of multiple existing laws in India, drawing comparisons with international laws and identifying gaps. Final outcome would be publications with coauthorship, and acknowledgement in final thesis paper. Hoping to hear from my esteemed network
how is the Effective of Implementation of Policy on Healthy Diet and Physical Activities Related to Control Strategies for Non-Communicable Disease, (provide more link is more welcome, please)
I am in the process of conducting a research in health policy that helps reconciles health financing and avaliability of quality health services.
Good morning
I hope you all doing great and safe
I got Bachelor degree on health administration and master on health administration concentration in health informatics .
I want to start a PHD research on Health policy, Health management or Health services research or any related major ,
I am looking for a interesting topics ,I had topic interest which was the impact of modern health technology on health research and policy and its consequences but I couldnot narrow the problem question which impact negitivaly on my acceptance , so Now I want you please to help me to find topic interest under the topic of learning health system or any related you think will help me .
appreciate your time
I'll be happy to give someone comprehensive Mta-Analysis version2.
Best Regards,
zeynab farhadi
phd candiate of health policy
Iran university of medical science
Many countries are in lockdown to reduce the impact of Covid19. This method has been proven to work in China (Wuhan) and previously in those US cities which triggered it early and firmly in the 1918 influenza pandemic.
Now what are the exit scenarios?
The French government has said last week (first week of April) that it was evaluating multiple scenarios to exit the lockdown, step by step, region by region.
Some articles have been published casting light on some aspects :
What are the possible exit steps?
Is testing a must prior to this as shown in an article by Economic Nobel Prize Winner Paul Romer?
Please share your views and input, with needed references
Unfortunately, in many underdeveloped and some developing countries, the health status is still poor. This problem causes the people of these countries not to have proper access to optimal health services. How is the health system in your country? What do you think about the weaknesses of the health system in underdeveloped and developing countries? In your opinion, what are the causes of this inappropriate situation? Please share your views with us.
It is very clear that, Pharmacists are not getting involved in health policies even though they are having a very good role in it. A positive friendly discussion will be appreciated without criticizing anyone. What kind of researches needed on this aspects?
I am measuring the effect of a time event (Health Policy) on an outcome (Recent Use of Health Services). I have a baseline measure (use within 6 months at baseline), a pre-time event outcome measure (use within 6 months at pre-time event follow-up measure) and a post-time event outcome measure (use within 6 months of post-time even follow-up measure). The time-event is binary and is the main independent variable being tested as a main exposure variable. The outcome variable can either be the change from pre-post (ordinally: increase, decrease, no change) or as the post-time event outcome (binary) given I adjust for the pre-time event outcome (binary). Which method and framing to this question is optimal?
Hi
I got Bachelor degree on public health and master on health service management .
I want to start a PHD research on Health policy, Health management or Health logistics ,
I am looking for a topic interesting topics , but until now I do not find any ,
So please If you could advice me about a topics that interesting and new would be great
Affordable Care Act impact?
AoA participation?
Dear Colleagues,
As a member of the ICN-APN Health Policy Subgroup i'm seeking your help to conduct a SWOT (Strengths, Weaknesses, Opportunities, and Threats) analysis for the status of Advanced Nursing Practice in the Eastern Mediterranean Region.
Eastern Mediterranean Region including the following countries:
Afghanistan, Bahrain, Djibouti, Egypt, Iran (Islamic Republic of), Iraq, Jordan, Kuwait, Lebanon, Libya, Morocco, Oman, Pakistan, Qatar, Saudi Arabia, Somalia, Sudan, Syrian Arab Republic, Tunisia, United Arab Emirates.
I would appreciate if you could complete the attached template to describe the APN regulatory considerations including:
1. Regulatory authority over APN practice
2. APN Educational and accreditation policy
3. APN Licensure and title protection
4. Role and scope of practice regulations
Please do not hesitate to contact me for further information by posting down or e-mail me on anashwan861@outlook.com
Best Regards
Abdulqadir
Health policy folks must now look at the states that did not expand Medicaid access to care for the low income populations.
FIND THIS ARTICLE AND SPREAD NEWS ABOUT IT. THIS IS AN IMPORTANT, BRAND NEW, POLICY ANALYSIS THAT IS VERY GOOD NEWS FOR THOSE WHO "GET IT" ABOUT HEALTH CARE AND THE UNDER-SERVED.
American Journal of Public Health, February 2018, Vol. 108 No 2.
A. Somi, et al. pp 216-218
Correspond with first author...good for Indiana U. School of Public Health
apsomi@indiana.edu
Here it is....such analyses require a little bit of time to conduct, but it is clear that expansion of Medicaid substantially, profoundly, increased initial early stage and overall diagnoses of cancer in states that expanded Medicaid under the Affordable Care Act. Late-stage diagnoses were not affected....undoubtedly because patients were already experiencing symptoms and problems that had drawn them into the system already.
Why is this important? It is because those people who were expanded into Medicaid represent lots of the most at-risk in the population of not getting early diagnosis, screening, routine medical examinations, and miss the opportunity of early diagnosis without access to care (financial access). This expansion effect on early stage cancer is very significant because in addition to being more humane and medically effective, the burden of cost for late-stage discovery of cancer has certainly been reduced in those states that expanded Medicaid.
Now, anyone who claims that the ACA "did not work" will need to address the question about why those states that did not expand did not experience the successful early stage detection of cancers....or, in the world of fake news and political spin, perhaps the current Administration will claim that the ACA caused more early stage cancers....I would not be surprised.
Just the opinion of a health professional on the Healthy weight, healthy lives policy in the UK, how effective it has been and what could be improved or crucial when implementing it today.
Here is the link to the health policy: https://extranet.who.int/nutrition/gina/sites/default/files/GBR%202008%20Healthy%20Weight%2C%20Healthy%20Lives-%20A%20Cross-Government%20Strategy%20for%20England.pdf
thank you in advance
Looking at the Indian context with the recent introduction of the National Mental Health Policy 2014 and the Mental Healthcare Act, 2017.
I am trying to compare two time series and I am in the process of assessing different methodologies to compare their relationship.
If you have used the Granger test, are you willing to share some literature on the topic please?
Looking at the Indian context with the recent introduction of the National Mental Health Policy 2014 and the Mental Healthcare Act, 2017.
Performing Systematic Reviews and Meta-Analysis of prevalence studies (concerning ophthalmological disorder), is possible to consider the appraisal checklist presented by the Joanna Briggs Institute (Munn et al., 2014; 2015) as the better tool available?
This because NOT all the SR and MA of prevalence studies - published beyond 2015 - are using this instrument.
- Munn, Zachary, et al. "Methodological guidance for systematic reviews of observational epidemiological studies reporting prevalence and cumulative incidence data." International journal of evidence-based healthcare 13.3 (2015): 147-153.
- Munn, Zachary, et al. "The development of a critical appraisal tool for use in systematic reviews addressing questions of prevalence." International journal of health policy and management 3.3 (2014): 123.
Background: A city-state like Hamburg (Germany) has many health-related actors and activities, yet when competing with other values and interests (e.g., in urban planning debate), health is a “weak” topic. A better understanding of the dynamics of local health policy, including political discussion and parliamentary debate, should be helpful for strengthening the case for health.
While conducting a preliminary analysis (ref. below), we realized that parliamentary documents are a hitherto underutilized source for (local etc.) health policy, calling for exchange and cooperation across localities.
Ref.: Hornberg, C., Fehr, R. (2015): Identifying major trends of health policy in a German city state – using hitherto neglected sources. European Public Health (EPH) Conference: Health in Europe – from global to local: policies, methods and practices, Milano (I), 15-17 Oct 2015. European Journal of Public Health, Vol.25, Suppl.3, p.96.
For years I have been thinking and raising the point that to some different degrees, our health has been significantly influenced by politics dressed as democracy, human right or religion. Selfish and self-centered abuse of power produced by political systems or religious systems has served to provide planned benefits for individuals (such as fame, position…) or a system, a nation (such as economical growth), but the price has been paid by others. For example, I see important links between inciting wars with the need for gun sale of some countries, the resources existed in target countries (such as oil ), as well as the political gains internally or externally. I see the link between our individual, group or national selfishness and health challenges and health inequity. I see that religious wars have roots in politics. To be honest I am very afraid that in the name of democracy or religion we witness more wars, hunger and inequity in health.
Evelyne De leeuw and I had a presentation in a health promotion conference in regards to politics and religions as ignored determinants of health. I can send you our presentation slides if you are interested.
I wonder whether health promotion professional have any roles to play? Can we do better in highlighting these links and advocate for ethical politics (if possible!) , ethical economical growth (respecting the rights of other systems (environment and social systems ) and more mutual understanding between followers of different faiths? I would like to know what you think.
Kindly suggest articles in the area of health intervention evaluation where changing age structure is also controlled for.
Thanks in advance!
Increasing unexpected healthcare utilisation in developed countries has led to several questions from the stakeholders, especially the health policy makers. Critics say unexpected healthcare utilisation cannot be prevented, while others say unscheduled utilisation can be avoided if adequate measures are put in place.
I believe, if the root cause of unexpected healthcare utilisation is known, there may be significant reduction to the high influx of patients to the health centres.
Question: In your opinion, what are the factors responsible for sudden utilisation of our health centres?
I wish to research into the phenomenon of radical innovations in health policies in India. I could find 7 cases which satisfy my operational definition of radical innovation. Within each case, I would interview at least 2 people. My objective is to create a substantive theory of radical innovation in health policy.
Could I follow Grounded Theory Method (GTM) with a pre-fixed number of case studies? I can not guarantee to add on cases till I achieve theoretical saturation.
I am looking for a comparative study on the mental health policies in Europe. My main focus is the psychiatric hospital and the covered versions of it which reintroduce institutionalization of psychiatric patients. Anyone can suggest me good books or some good articles? Thanks.
health policy reforms in kenya
The use of ethnographic method to evaluate compliance with protocol.
Advocacy Coalition Framework basically applies to policy making in developed countries. In order to apply it to health policy change in developing countries, how must one proceed?
I am current working at NGO in Nepal. I want to conduct a research on policy analysis with more focus on National mental health policy of Nepal. If anyone could suggest me scientific methods or tools to carry out the research it would be very helpful for me.
Thanks
Many policy advocates, a few mainstream politicians, and some economists propose that free markets can manage environmental problems as a sole solution. That seems unlikely, because of market distortions, perverse incentives, incomplete information, long lead times before markets are likely to respond to health issues, and weak "signals" of environmental damage that change behavior of producers. Obviously there are ideological implications derived from liberalism/laissez-faire capitalism and as a minority opinion it is primarily an "Anglo-Saxon" (i.e. North American, UK, Australian, not so much NZ) point of view. However, the notion has produced an enormous number of books, papers, and reports. On the other hand, I don't see very many analyses specifically on the role of free markets as an "80%" solution (Pareto Principle), managing most problems most of the time and reducing the burden of regulation but not the need for it. This seems to me to be pivotal in environmental/occupational health policy but not much remarked upon. Maybe it is too obvious or maybe it is oversimplistic. Do you know of a body of literature that treats free markets as an essential but partial solution to societal risk management?
Please can anybody tell me how Mandatory Health Insurance affects UHC in developing countries?
Students of nursing administration course are requested to select a health policy of interest and evaluate it. Students are supposed to summarize strengths and opportunities for improvement. Would anyone suggest criteria or guidelines for evaluating a health policy?
Health Policy. Please High light the procedure in proposing a health Policy?
I am looking for real examples on how population attributable fraction estimates were crucial to guide a public health policy (e.g. implementation or reaching goals).
I am currently using semi-structured interviews with organization representatives from the public, private and voluntary sectors within the health policy area. I use non-random, purposive sampling to select the interviewees. The organizations under investigation are involved in collaborative health policy making and the interviewees must have sufficient knowledge on their organizations' collaborative projects.
- Thinktanks
- Policy groups
- Focused discussions
- Other
Dear Cochrane Reviewers,
In order to finish a Cochrane review, the authors (including myself) must use a Summary of Finding table using Grade Pro. This procedure, in some Cochrane Groups, is mandatory. I’ve tried to use it, but I still haven’t succeeded, even with some tips available in the Cochrane’s groups.
Would anyone have any suggestions or a step by step that can be useful not only for me, but also for everyone who has the same problem?
Best,
Jefferson
Missing (or at least unremarked upon) in the debate about Obamacare in particular and health policy in general is the value/worth of continuity of care, i.e. more integrated systems vs less integrated systems
Health Policy globally needs redesign to include “social determinants of health” There is a need to reorganize care around achieving value for patients. In order to improve health outcomes for patients, we first need to define all the activities that are likely to enhance health for specific segments of the population. Health care redesign should essentially include into clinical settings the activities that will influence the social factors (address social needs, such as a lack of housing or access to adequate food) that are intertwined with health. How important it is for clinicians to associate personnel with expertise in social determinants of health to support patients?
If you have an interest in disability and chronic health conditions, would like to collaborate on an interesting mHealth project using the ICF, please take the survey at the attached link: https://www.surveymonkey.com/s/mICF
Our group is working on the high education aspects of a broader research that aim to analyse the health Industrial Economic Complex and the structural challenges for the Universal Health System in Brazil.
The UK's Health and Safety Executive has long promoted the building of occupational safety and health management systems on a foundation known as POPMAR (Policy, Organization, Planning, Monitoring, Auditing, and Review) but they are now shifting to PDCA (Plan, Do, Check, Act). I am interested to know is this just a reorganization or is it a radical change and what impact will the change have on industry.
I would like to connect with someone who has worked in the NWT around health policy. I am interested in how to engage the local population in the policy process.
If I want to carry out a systematic review of China's health policy based on Chinese literature, because this specific topic has not been published yet on English language academy, is it acceptable that the review's reference is majorly Chinese?
I am looking both for personal opinions as well as references (scholars' books or articles, official documents from EU institutions, ...)
There is an urgent need to take initiatives to formulate an effective national policy to control the rising trend of antimicrobial resistance in India, including a ban on over-the-counter sale of antibiotics, and changes in the medical education curriculum to include training on antibiotic usage and infection control. I would be very much interested to know how the developed countries are handling such a situation and make proactive measures in preventing antimicrobial resistance. Your opinions and suggestions are highly appreciated.
I have found various tools that have been developed to measure structural aspects of integrated care as well as measures assessing healthcare provider’s attitudes toward care teams but have been unable to find a measure specific to integrated care delivery.
I am running a PCA analysis to create wealth index in a sample where people are living in both urban and rural area, one of the main variables I am using is livestock. This is quite common in rural areas and not so common in urban areas. In urban areas we feel that owning livestock somewhat indicates one not being wealthy, where as in rural areas it indicates if one is wealthy so this variable is working in two directions. Any good suggestions how we can tackle this situation without splitting our sample on urban and rural populations?
I am interested if any country uses the same ESA85 and ESA50 forms. Or if there are any other forms alike - could you suggest any certain policy paper (of any European country) for seeing the explanations (and imperfections) for certain workability assessment method.
Current U.S. policymaker concerns with "Pay-for-Performance" and "Value- Based-Purchasing" and "Provider Outcomes Evaluation" seem to miss the mark in various dimensions based on this early approach that takes a more broad perspecitve beyond traditional "cost-effectiveness" or "cost-benefit" analyses. The weblink for this publication is:
It would seem that regardless of the structure or legislation attached to Policy & Procedure that human error is not the greatest problem we have with clinicians. Non compliance to process rears up time and time again. What tactics/campaigns are others using in an attempt to improve non compliance? What studies are currently in process to address this? All helpful comments are appreciated.
I have found the FDA guidelines for labeling supplements. There are many supplements that are metabolized along the CYP450 pathway and, thus, interact with medications. I believe that a warning should be added to the label indicating the potential for drug interactions.
Low health literacy affects many people, the cost is significant.
I am seeking information to inform strengthening of a national medical training reform to expand access to training
Health is a critical dimension of human development as outlined in the Millennium Development Goals (MDGs). However, India is still grappling with the persistent rural- urban divide. The nation today urgently needs to strengthen the country’s rural health infrastructure to better its health status beyond the middle and upper classes of society.
I recently had a bout with shingles - which, among other things, can cause permanent nerve problems. Although there is a vaccine (which I didn't even know about) that prevents shingles, insurance will not cover it until a person reaches the age of 60. I am under the age of 60 (58), and know quite a few people under the age of 60 who have gotten shingles. Does anyone know the reasoning behind the age 60 requirement (is there a medical reason?) or why the shingles vaccine is not advertised more, given that one in three (or one in five, depending on who you read) people are going to get this at some point in the their later years? Doctors push so much other screening, etc., why not this, when it can be debilitating, very painful, and is preventable?