Abstracts of the 45th Congress of the Société Internationale d’Urologie

From efficacy to cost-effectiveness

Statistical methods that are commonly used in the review and approval process of regulatory submissions are usually referred to as statistics in regulatory science or regulatory statistics. In a broader sense, statistics in regulatory science can be defined as valid statistics that are employed in the review and approval process of regulatory submissions of pharmaceutical products. In addition, statistics in regulatory science are involved with the development of regulatory policy, guidance, and regulatory critical clinical initiatives related research. This book is devoted to the discussion of statistics in regulatory science for pharmaceutical development. It covers practical issues that are commonly encountered in regulatory science of pharmaceutical research and development including topics related to research activities, review of regulatory submissions, recent critical clinical initiatives, and policy/guidance development in regulatory science. Devoted entirely to discussing statistics in regulatory science for pharmaceutical development. Reviews critical issues (e.g., endpoint/margin selection and complex innovative design such as adaptive trial design) in the pharmaceutical development and regulatory approval process. Clarifies controversial statistical issues (e.g., hypothesis testing versus confidence interval approach, missing data/estimands, multiplicity, and Bayesian design and approach) in review/approval of regulatory submissions. Proposes innovative thinking regarding study designs and statistical methods (e.g., n-of-1 trial design, adaptive trial design, and probability monitoring procedure for sample size) for rare disease drug development. Provides insight regarding current regulatory clinical initiatives (e.g., precision/personalized medicine, biomarker-driven target clinical trials, model informed drug development, big data analytics, and real world data/evidence). This book provides key statistical concepts, innovative designs, and analysis methods that are useful in regulatory science. Also included are some practical, challenging, and controversial issues that are commonly seen in the review and approval process of regulatory submissions. About the author Shein-Chung Chow, Ph.D. is currently a Professor at Duke University School of Medicine, Durham, NC. He was previously the Associate Director at the Office of Biostatistics, Center for Drug Evaluation and Research, United States Food and Drug Administration (FDA). Dr. Chow has also held various positions in the pharmaceutical industry such as Vice President at Millennium, Cambridge, MA, Executive Director at Covance, Princeton, NJ, and Director and Department Head at Bristol-Myers Squibb, Plainsboro, NJ. He was elected Fellow of the American Statistical Association and an elected member of the ISI (International Statistical Institute). Dr. Chow is Editor-in-Chief of the Journal of Biopharmaceutical Statistics and Biostatistics Book Series, Chapman and Hall/CRC Press, Taylor & Francis, New York. Dr. Chow is the author or co-author of over 300 methodology papers and 30 books.

Advancing racial and ethnic equity in science, medicine, and health: a call for papers

Purpose: The National Cancer Institute’s (NCI’s) Cancer Research Data Commons (CRDC) is a data ecosystem for the cancer research community that provides cloud-based, secure storage and analytic tools for many cancer data types, including genomic, proteomic, imaging, and clinical data. CRDC requires a carefully designed, federated data governance framework to enable CRDC’s goals to sustain a collaborative data environment where researchers can access timely, accurate, and relevant cancer data. Methods: In 2023, CRDC chartered a Data Governance Framework of Committees and Working Groups across all CRDC components to: Enable diverse data type sharing; provide secure data access; optimize common infrastructure components and functions; and adhere to FAIR data principles (Findable, Accessible, Interoperable, and Reusable). We considered many designs for the CRDC Data Governance Framework, including fully centralizing or decentralizing decision-making bodies. Implementing a fully centralized data governance framework for a diverse data ecosystem like CRDC would risk top-down decisions that do not meet the unique needs of the CRDC and cancer research community. A fully decentralized data governance framework risks inconsistencies and compliance challenges. Additional governance design considerations included a federated approach that emphasizes clear roles and responsibilities; prioritizing cross-component policies to ensure consistency and promote operational efficiency; defining measurable performance standards; and keeping data owners, stewards, and users informed, trained, and supported. Results: We have determined that long term sustainment of CRDC requires a federated governance approach with broad stakeholder participation through Committees and Working Groups. Currently established CRDC governance committees include the Enterprise Architecture Review Team (EART), Submission Review Team, Data Standards Working Group, and Data Advisory Board consisting of cancer research domain experts, researchers, and skilled cloud engineers and developers. In 2023, the CRDC EART defined data lifecycle stages and identified technical optimization opportunities for submission coordination and indexing. The established governance groups are working to identify optimization opportunities for data quality checks, submission review workflows, study acceptance criteria, data submission reviews, and cross-CRDC emerging data standards requirements. Conclusions: Sustaining large, complex, cancer research data requires a federated governance approach with participation from all relevant stakeholder groups and cannot simply be top-down imposition of policies, standards, and procedures. The newly established CRDC federated governance framework will contribute to improving the long-term sustainability of the CRDC infrastructure and ensuring CRDC data drive meaningful research outcomes. Citation Format: Juergen Klenk, Dina Mikdadi, Chelsea Owens, Angela Maggio, Bhavani Singh, Eric Barner, Tanja Davidsen, Erika Kim. Managing large-scale cancer research data programs [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 3568.

Since last year The British Journal of Clinical Pharmacology has been available in electronic form, free to members of the British Pharmacological Society. This month the Journal takes the next step and launches an online submission and peer review system using Manuscript Central™ software at http://bcp.manuscriptcentral.com. Currently, the time between submission of papers and their acceptance (after revision) or rejection runs between 65 and 114 days. It is hoped that Manuscript Central™ can speed this up and refine the review process even more. A significant proportion of the period between submission and the final decision by the Editors can be attributed to papers in transit between the Editorial Office, Editors, Executive Editors, referees, and authors. Manuscript Central™ will accelerate the review process by cutting out these delays. A flow chart of the operation of Manuscript Central™ customized for the Journal is shown in Figure 1. Figure 1 Flow chart of the operation of Manuscript CentralTM. What does electronic submission involve and what are its benefits to authors? The vast majority of papers are now written on a word processor and most figures are created electronically. The system allows authors to load their papers directly onto the Manuscript Central™ web site in a variety of formats (the Editorial Office will do this if requested). The vagaries of the various national and international postal services will be a thing of the past. Immediately on submission, authors will receive an acknowledgement and manuscript number by E-mail. Subsequent transfer of papers between the Editorial Office, the Editors, Executive Editors, Referees, and back to Authors will be entirely electronic and thus, ‘instantaneous’. In addition, the whole peer review process is designed to be transparent, within the bounds of confidentiality. Authors will be able to log on to the Manuscript Central™ web site and monitor the progress of their submitted paper. They will be able to respond to referees’ and editorial comments, resubmit revised manuscripts and track their progress, all online. Access is 24 h a day, 7 days a week. However, we do realize that some authors will not be quite so enthusiastic about this initiative. If authors cannot or do not wish to submit their paper electronically, the Journal will accept hard copy in the normal way. Papers will then be scanned into the system, and processed through Manuscript Central™. How will the new system affect referees? Recently, we have begun to confirm individual referee's availability by E-mail. Those that agree to review a paper will now be asked to visit the Manuscript Central™ web site and down load the paper for viewing on screen or printing. Comments (which can be cut and pasted from any word processor) and recommendations are submitted online, and become immediately available to the Editors or Executive Editors for their consideration. Referees who do not wish to use this system at present can request a paper copy and review the paper in the normal way. Despite some anticipated teething troubles, we firmly believe that electronic submission and peer review will increase the speed of publication and enhance the quality of the Journal. Thus, we encourage all authors and referees to make use of Manuscript Central™, even those whose use of computers and the internet has yet to prove a positive experience. Full instructions for manuscript submission are available on their web site at http://bcp.manuscriptcentral.com. In addition, advice and support is available by telephone (in the UK +442074044101 and in the USA +18668493738), by E-mail: (ku.oc.icskcalb@lartnectpircsunam) on the Web at http://blackwellsupport.custhelp.com, or by clicking the ‘Get Help Now’ icon on the site at any point. It should be stressed that the Editorial Office (staffed by humans who answer telephones) will still function in the same way, and will not be replaced by a computer somewhere in cyberspace!

Editorial management of articles on health economics may benefit from guidelines for peer review and revision. To assess whether publication (in August 1996) of the BMJ guidelines on peer review of economics submissions made any difference to editorial and peer review processes, quality of submitted manuscripts, and quality of published manuscripts. Before-after study conducted in the editorial offices of BMJ and The Lancet of the effect of the BMJ guidelines on review and revision of economics submissions, defined as those making explicit comments about resource allocation and/or costs of interventions. Editorial fate and changes in the quality of submissions. A total of 2982 manuscripts were submitted to the 2 journals during the before periods, 105 (3.5%) of which were economics submissions. Of these, 27 (24.3%) were full economics evaluations, and 78 (75.7%) were other economics submissions. Overall acceptance rate was 11.6% (12/105). During the after period 2077 manuscripts were submitted to the 2 journals, 87 (4.2%) of which were economics submissions. Eighteen (20.7%) were full economics evaluations, and 69 (79.3%) were other economics submissions. Overall acceptance rate was 6.9% (6/87). Although a number of manuscripts could not be traced to determine whether they were economics submissions, there appeared to be little difference between the 2 journals in numbers or editorial fate of the manuscripts. There was no change in the quality of submitted manuscripts, but BMJ editors found the guidelines and checklists useful and sent fewer economics submissions for external peer review in the after phase. Publication of the guidelines helped the BMJ editors improve the efficiency of the editorial process but had no impact on the quality of economics evaluations submitted or published.

I began my term as editor of AJIDD in January 2008. Since that time, we have received more than 200 new manuscripts to consider for publication. As we begin publishing our 2010 volume, I want to share some data about the Journal, provide a glimpse into some future issues, highlight an important change in our policy regarding the reporting of nonsignificant findings, and briefly comment on the passing of two prominent leaders.I thought it would be useful to share data regarding the outcomes of the editorial process for the Journal as well as information about the readership. Such data are used by many audiences, including academic bodies that evaluate faculty members being considered for promotion, tenure, or awards. I have based these data only on submissions for 2008. I hope to do similar updates on an annual basis.In 2008, AJIDD received 111 new submissions for review. As I write this editorial (September 2009), final editorial decisions have been made on all but 13, with the latter either still being revised by the authors or having been revised and resubmitted for further review. Of the 98 manuscripts for which final decisions have been made, 32.7% were accepted. Importantly, no new submission in 2008 was accepted without change; all required revision. The median time from first submission to initial editorial feedback was 54 days, a number that we are hoping to improve.In terms of content, more than 90% of the articles submitted were reports of empirical studies rather than research reviews or theoretical papers. It is interesting that the submissions were quite diverse in terms of the home country of the lead author. Manuscripts were submitted by authors from 23 countries. Although more manuscripts were submitted by authors from the United States than any other single country, more than half of the manuscripts were submitted from authors based outside of the United States. Clearly, despite its name, AJIDD is increasingly an international journal, and this is a trend we wish to foster.In terms of readership, each issue of AJIDD is distributed in print to 2,874 individuals and 944 libraries. Through electronic subscriptions, AJIDD reaches even more individuals at institutions that maintain a current subscription.Archived issues of the Journal are available free-of-charge on-line at http://aaidd.allenpress.com/aamronline/?request=index-html. Current articles can be accessed at that same site. Abstracts for all articles are free.In the 2010 volume, we will be publishing a special issue devoted to cognitive neuroscience approaches to the study of intellectual and developmental disabilities. This issue includes some truly exciting and path-breaking research that will illuminate the causes of a variety of developmental problems and suggest possible avenues for treatment. I am indebted to Tony Simon, an associate editor for AJIDD, for editing this special issue. It required a tremendous amount of work on his part, but it has helped to open a whole new era for AJIDD.In 2010, we will also publish a special section on evidence-based treatments for individuals with intellectual and developmental disabilities. We hope that this will be the first in a series of special sections devoted to evidenced-based treatments, each with a somewhat different emphasis. This effort has been led by Ann Kaiser, an associate editor for AJIDD, and Laura Lee McIntyre. They have solicited an exciting collection of submissions for this first special section and are working diligently to complete the editorial process for its publication late in 2010. I am very grateful to them for leading this ongoing effort to help translate research into practice in the pages of AJIDD.For many years, it has been the policy of AJIDD not to report inferential statistics when presenting nonsignificant findings. For example, if a t test involving a comparison of two groups on a dependent measure was nonsignificant, the author was encouraged simply to indicate that the "groups did not differ" rather than reporting the value of the t test, the p value, etc. In fact, this is often a good strategy, saving journal space and making the article easier to read.There are, however, many instances in which it is important to provide complete statistical information for a nonsignificant finding. A case in point is the matched-group design, which is common in our field. This design involves matching two or more groups on a measure, such as age, IQ, or mental age. The logic of this design, many have argued, requires more than simply demonstrating that the average difference between the groups on the so-called matching variable failed to exceed a p ≤ .05 level of significance. Would a "nonsignificant" difference that reaches a p value of .06 really give one confidence that the groups are "matched?" Indeed, Carolyn Mervis and her colleagues have argued persuasively that groups should not be considered as matched on a variable unless the p value associated with a comparison of their means reaches .50 (Mervis, 2004; Mervis & Klein-Tasman, 2004; Mervis & Robinson, 1999). Other authors have made similar suggestions in other contexts (e.g., Frick, 1995).My point is not to insist that every matched-group design study published in AJIDD achieve a particular p value in comparisons of the groups on the matching variable (although a failure to achieve such a p value is likely to require other evidence or additional statistical methods, such as ANCOVA). Instead, my point here is that a reviewer or reader must be able to evaluate the claim that the groups in such a design have been matched appropriately, and this requires that the author provides supporting evidence in the form of a complete reporting of relevant statistics. In the case of other types of designs, I also strongly encourage authors to think carefully about their designs and claims and report the statistics for nonsignificant findings when doing so is important to the evaluation of the study by readers. We will not routinely say "no" to the full reporting of nonsignificant findings when the authors provide an adequate rationale, and, in some cases, such as the matched-groups design, we will insist on full reporting.Unfortunately, 2009 marked the passing of Eunice Kennedy Shriver and Senator Edward Kennedy. It is difficult to put into words all that these two remarkable people achieved on behalf of people with developmental disabilities. They shaped polices and helped create systems that provide ongoing support for research into the causes, consequences, and treatment of developmental disabilities, and they worked to produce ongoing opportunities for people with developmental disabilities to contribute to and participate fully in their communities. They taught us all about the need to respect, value, and support all people without regard to level of ability. Mrs. Shriver and Senator Kennedy will be missed, but their influence on our work and our lives will continue.

The purpose of this editorial is to address ongoing concerns for research design problems, statistical analysis problems, and research study conclusions made in manuscripts and published articles. Editorial dilemmas are created when editors recognize important research ideas, but the research manuscripts for these ideas reflect poorly argued studies. When such dilemmas occur, journal editors are generally limited to one of the following options: 1) Rejecting a paper that simply is not tenable; 2) encouraging the author(s) to rewrite the paper and resubmit a revised paper; or 3) becoming ghost writers for the author(s) to bring an acceptable level of quality to the paper.Nuijten1 reported evidence to support an argument that statistical reporting errors are distorting scientific literature. Nuijten further reported that publication bias was the most prominent reason given, and provided the following concrete solutions to correct this problem:Allison et al.2 wrote that procedural and analytic mistakes in peer reviewed papers are discoverable; however, they are sometimes impossible to fix. Allison et al. further attempted to address more than 25 procedural and analytic errors. Journal editors, they reported, were sincere in their reviews; however, the manuscripts were generally not well prepared. Allison et al. cited ten editorial problems, including several listed below:Noorden3 addressed the problem of inaccurate use of statistics in published papers and discussed Science as an example of a journal that is taking action to correct such inaccuracies. Noorden reported that Science: 1) retains seven statisticians on a Statistical Board of Reviewing Editors (SBoRE) and 2) strongly recommends all papers reporting potential new biomarkers be evaluated by an independent statistician before submission for review (see http://www.sciencemag.org/authors/science-editorial-policies).Kass et al.4 recommended simple rules for effectively addressing statistical arguments in science papers. Using a list format with editorial comments, Kass et al. included some of the following rules:In response to the concern for research design problems, statistical analysis problems, and research study conclusions, Journal of Oral Implantology (JOI) has taken the following steps to improve the quality of the manuscripts submitted for review:Journal editors have responsibilities to ensure the accuracy of published scientifically argued papers, to protect the patients who practitioners treat based upon the finding of published scientific papers, and to ensure that published scientific papers have tenable longevity as progressive technology advancements are used to test the scientific merits of journal publications. The position of JOI is that these responsibilities need to be shared more fully with authors of scientific papers vying for publication in journals and not simply the responsibilities of journal editorial boards.

In the published article, there was an error in Figure 5 as published, although the caption is correct. Figure 5 in the published paper is from the first submission for review. The revised Figure 5 has different subfigures B, C, and D which are located in squares b–d in Figure 4. The corrected Figure 5 and its caption appear below.The authors apologize for this error and state that this does not change the scientific conclusions of the article in any way. The original article has been updated.

The Book Reviews section will introduce you to the latest and most interesting books on a wide range of topics pertaining to the law and policy of risk regulation. EJRR Book Reviews will strive to be present in every edition and will accept reviews from all disciplines. For further information on the submission of reviews please contact the Book Reviews Editor at david.hornsby@wits.ac.za.

This article was originally published online on 15 january 2008 The world has gotten smaller, and continues to shrink! What goes on in Beijing or Cairo needs to be communicated to New York and Paris. To establish a rapid, efficient, and cost-effective communication system, the World Allergy Organization (WAO) has created a new unique on-line journal, the World Allergy Organization Journal or the WAO Journal. We envision this journal to be a clinically oriented communication, blending excellent reviews with clinically applied research. We have established an excellent international editorial board, contracted with Lippincott to publish the journal, and will fund the initial distribution, starting with volume 1, January 2008. The WAO has made a major commitment to the success of this journal, which will be distributed to more than 25,000 allergists worldwide, ensuring that the WAO Journal will immediately reach more allergists than any other publication in the world. We can count on this immediate and extensive impact because our biweekly e-newsletter is a huge success: it has a vast global readership and is translated into 7 languages. We are actively soliciting both high-quality reviews and translational research articles for publication, and greatly look forward to receiving your submission for review. After 18 years, the Allergy and Clinical Immunology International (ACII), the journal of the World Allergy Organization, has been discontinued. This journal was fun to read and was always interesting. However, it never achieved the readership it deserved or required for continuation, nor was it included in any of the citation indices. We thank those of our colleagues who supported ACII, particularly the past editors, Alain de Weck and Allen Kaplan, and the publisher Hogrefe and Huber. The WAO is giving a special recognition award to Rob Dimbleby of Hogrefe and Huber for his highly valued support. Johannes Ring, the current editor of ACII, will transition to the editorship of the WAO Journal, joined by Lanny Rosenwasser as coeditor. They have assembled a group of world-renowned allergists as regional editors and an excellent editorial board. Thus, the WAO recognizes the responsibility it has to facilitate excellence in allergy. We are committed to providing education through our lecture series (GLORIA, The Seminars and Conferences Lectureships, and the World Allergy Forum), Web site-related materials and case reports, our new webinars on immunology (cosponsored by the American Academy of Allergy Asthma and Immunology, and available soon on both our Web sites), a new series of on-line Continuing Medical Education programs based on clinical case histories in allergy, and the Emerging Societies Program (which, in partnership with the American College of Allergy, Asthma and Immunology, has continued to support educational activities in 2007 programs held in Thailand, China, and Latin America). The WAO is now taking this next step to help the world of allergy communicate by sponsoring the new on-line journal. We promise you that it will maintain the highest standards with respect to both review articles and original research. We promise that the subscription cost of the journal will be inexpensive, and that the journal will arrive on-line and on time on your computer. Publication will be rapid and will focus on clinically relevant materials. The WAO journal will continue to be complemented by the biweekly e-newsletter, where important relevant articles will be summarized with commentary and news, and announcements from around the world will be communicated. Thus, you will be receiving continued on-line information from WAO, and the opportunity to communicate observations or information from wherever you work to the rest of world will achieve a new level of availability. Yes, the world is shrinking, we are all working together at a new level of communication, and the WAO journal is an important cog in the wheel that will take us forward. We hope that you love and use this new journal. We all need to work together to ensure its success.

At the results of the detailed petrograhpic studies it was established that the upper Jurassic deposits (incapable to generate oil) have been intensively bioturbatied. The forms with tracefossils Chondrites had highest quantity of the population. Apparently, this ihnofossils belonged to the colony eurybiontic organisms (detritofags), which preferred seaweed detritus and products of its bacteria destruction. This organisms has played important part in pauperization of the «bagenov» sea coastal parts by sapropel when its biggest in primary deposits. Assume, that seaweed plantations biofilters (the same to modern) could absorbe much hydrocarbons, for example metane, which emanated on the fracture zones from Paleozoic rocks, lying under thick Jurassic deposits. The saturation of the benthonic layers by metane created impossible environment for detritofags. Thus, conditions for preservation of the sapropel, saturated by hydrocarbons, were created.

Chapter 9 - Airworthiness verification test of the flight control system

The Coronary CT Angiography column focuses on the burgeoning field of noninvasive coronary angiography. Samuel Wann, MD, is the Section Editor and welcomes submissions for review and potential publication.—Sylvan Lee Weinberg, MD, Editor in Chief

Objective: The human genetic resources are the base of innovative research in the field of life science and technology nowadays. The concrete practice of informed consent is of great significance in reasonable protection of human genetic resources. The aim of this study was to compare the common ground and difference of informed consent between the collection, preservation and utilization of human genetic resources for the purpose of scientific research and such activities in clinical care and clinical trial, and discusses how to reflect and provide for informed consent in the legislation of human genetic resources. Material and Methods: The relevant Chinese laws and regulations since 1993 and Regulations on the Administration of Human Genetic Resources (Submission for Review) was collected and compared. And the practical dilemma of informed consent was analyzed from the perspective of ethics, law and social implications. Results: Informed consent in the human genetic resources collection, preservation and research and development activities has demonstrated different characteristics on the aspects of the subject of informed consent, informed contents and re-consent etc., which are also the very dilemma confronted by the practice of informed consent in the human genetic resources protection. Conclusion: The reasonable provision in human genetic resources-related legislation on informed consent should take into account both the human dignity and Self-Determination and the particularity of human genetic resources and social and natural human attributes.