- Data monitoring committees (DMCs) emerged in the 1970s to periodically review accumulating clinical trial data and monitor safety and efficacy. They issue judgments to stop or continue trials.
- DMCs have become reflexive institutions that engage in endogenous critical inquiry. They focus on issues like membership qualifications and attributes, and how much trials can be redefined based on interim data.
- Guidelines have been issued to provide standards around DMC roles, structures, and decision-making processes. There is debate around how independent DMCs should be and what level of access they should have to trial data and ability to influence trial parameters.
The Randomized Controlled Trial: The Gold Standard of Clinical Science and a ...marcus evans Network
Tim Fayram, St. Jude Medical Inc. - Speaker at the marcus evans Medical Device R&D Summit Fall 2013, held in Palm Beach, FL delivered his presentation entitled The Randomized Controlled Trial: The Gold Standard of Clinical Science and a Barrier to Innovation?
Biostatistics are widely used in clinical trials to collect and organize and describe and interpret these result and then give to us proves to take appropriate clinical decisions
The Randomized Controlled Trial: The Gold Standard of Clinical Science and a ...marcus evans Network
Tim Fayram, St. Jude Medical Inc. - Speaker at the marcus evans Medical Device R&D Summit Fall 2013, held in Palm Beach, FL delivered his presentation entitled The Randomized Controlled Trial: The Gold Standard of Clinical Science and a Barrier to Innovation?
Biostatistics are widely used in clinical trials to collect and organize and describe and interpret these result and then give to us proves to take appropriate clinical decisions
What Are the Different Types of Clinical Research or who can participate in it?Vial Trials
Participation in a clinical trial is an option for many people with serious illnesses, especially when no suitable treatments are available. Please read this blog here to know about the different types of clinical research or who can participate in it!
Research Methodology In Medical Research. This presentation gives an comprehensive overview of research methodology in biomedical research also includes different types of medical research and ethics in medical research.
Types Of Clinical Trials And Its Significance Clinical trials means medical research studies involving people. They are divided into different stages, called phases. The earliest phase trials might focus at whether a drug is safe or the side effects it causes. A later phase trial aims to test and compare whether a new treatment is better than existing ones.also checkwhy clinical trials are important in clinical research.
Meta-analysis in Epidemiology is:
Useful tool for epidemiological studies which investigates the relationships between certain risk factors and disease.
Useful tool to improve animal well-being and productivity
Despite of a wealth of suitable studies it is relatively underutilized in animal and veterinary science.
Meta-analysis can provide reliable results about diseases occurrence, pattern and impact in livestock.
It is utmost essential to take benefit of this statistical tool for produce. more reliable estimates of concern effects in animal and veterinary science data.
Presentation delivered by Rebecca Cann, Cultural Planning Supervisor, City of St. Catharines at The Ontario Rural Council's municipal cultural planning forum, "Economies in Transition" on November 17, 2008 in Brockville.
What Are the Different Types of Clinical Research or who can participate in it?Vial Trials
Participation in a clinical trial is an option for many people with serious illnesses, especially when no suitable treatments are available. Please read this blog here to know about the different types of clinical research or who can participate in it!
Research Methodology In Medical Research. This presentation gives an comprehensive overview of research methodology in biomedical research also includes different types of medical research and ethics in medical research.
Types Of Clinical Trials And Its Significance Clinical trials means medical research studies involving people. They are divided into different stages, called phases. The earliest phase trials might focus at whether a drug is safe or the side effects it causes. A later phase trial aims to test and compare whether a new treatment is better than existing ones.also checkwhy clinical trials are important in clinical research.
Meta-analysis in Epidemiology is:
Useful tool for epidemiological studies which investigates the relationships between certain risk factors and disease.
Useful tool to improve animal well-being and productivity
Despite of a wealth of suitable studies it is relatively underutilized in animal and veterinary science.
Meta-analysis can provide reliable results about diseases occurrence, pattern and impact in livestock.
It is utmost essential to take benefit of this statistical tool for produce. more reliable estimates of concern effects in animal and veterinary science data.
Presentation delivered by Rebecca Cann, Cultural Planning Supervisor, City of St. Catharines at The Ontario Rural Council's municipal cultural planning forum, "Economies in Transition" on November 17, 2008 in Brockville.
I computer sono ormai diventati uno strumento indispensabile per lo svolgimento di qualsiasi attività umana, professionale o sociale che sia. La brutta notizia è che le nostre informazioni, e tutti i nostri dati, vengono veicolati da sistemi informatici di cui ignoriamo la struttura. Cioè, non ci è dato a sapere come trattano i nostri contenuti, perché sono chiusi e inaccessibili nelle loro funzionalità più nascoste.
È evidente la potenziale pericolosità di affidare ciecamente i propri dati a sistemi che non siamo in grado di controllare. I sistemi basati su software a codice sorgente aperto eliminano questo rischio e consentono, di converso, di conoscere esattamente cosa succede alle cose che scriviamo e trasmettiamo.
Con il passaggio dagli atomi ai bit si è aperta una nuova era. Il nuovo paradigma non riguarda solo i computer, ma interagisce profondamente con le nostre abitudini e i nostri stili di vita.
In this paper we present a wide area distributed
system using a content-based publish/subscribe communication middleware
which can deterministically detect and report failures with respect to
timely message delivery and message omission. Our approach does not require
external clock synchronization nor does it impose any constraints on the
publish/subscribe middleware. We show that our system performs better and is
safer than when using NTP for external clock synchronization. We provide a
proof of concept implementation and present results of experiments carried
out in the PlanetLab environment.
Year end presentation for Cypris Chat English learning community in Second Life 2010. Presented by Mike McKay (aka Professor Merryman)
Presentations and data are made public to help further publicize the benefits of language learning in spatial voice enabled realistic virtual worlds. We recognize that there simply is no other better way to receive immediate exposure to the language and with so much fun. It being free, at Cypris Chat, makes this even better.
Determining Your Community's Competitive Advantage For The Creative SectorEmily Robson
Michael Florio, from OMAFRA’s rural community development branch will provide an overview of a ‘new’ practical economic analysis tool being developed to help communities identify their competitive advantages in the creative/cultural sector. As part of this overview, Michael will explain, how the information can systematically be used by a community/region to inform the development of a local strategy/action plans to grow the creative/cultural sector in a community/region.
Economies in Transition: Leveraing Cultural Assets for Prosperityes In Transi...Emily Robson
Presentation delivered by Peter Kenyon, Director of Bank of I.D.E.A.S in Perth, Australia. The presentation explores asset-based community development projects in rural and remote Australia and New Zealand. The presentation was delivered to The Ontario Rural Council's municipal cultural planning forum
Access versus dedicated panel: ESOMAR panel conference Dublin 2008Kristof De Wulf
After the rapid and widespread emergence of online access panels, we are currently witnessing a new trend towards online custom panels that are specifically built, used and managed for research purposes of one company or its brand(s). This study compares the online access panel ‘XL Online Panels’ with a dedicated and branded online research panel from Heinz, generating conclusions on the relative advantages and disadvantages related to using either of them. Specific attention is paid to panel member conditioning and quality.
The Medical Council of India regulates uniform standards of higher qualifications in medicine and recognition of medical qualifications in India and abroad. Official registration of doctors with recognized medical qualifications is controlled by the council, and procedures have been laid out under the Indian Medical Council Act 1956 and Indian Medical Degree Act 1916. Although there are no legal constraints specifically dealing with methodology of executing or dispensing medical services in India, various laws including the Drugs and Cosmetics Act, 1940 define negligence; criminal intent; sale, manufacture and distribution of drugs etc., while judicial precedent and case laws determine medical negligence on a case by case basis. The healthcare service provider adopting telemedicine methods of medical practice must ensure that medical consultation, prescriptions, treatment and drugs are dispensed only in accordance with legal provisions and guidelines regulating the medical and healthcare sector in India.
IT-Policy is the need of the of the hour. Why do each and every corporate house need an IT (Information Technology) Policy to deal with the Liability for the acts of Employees and Agents, Strict Liability, Vicarious Liability,
Data Protection and Secrecy, Email and Internet Usage, Laptop/Desktop Usage, Hardware Usage, Data card, Pen Drive, Security of Computer Network, System Access
Virus Protection, Installation Rights, System back up and Maintenance, Third Party and Remote Access etc.
Operations research within UK healthcare: A reviewHarender Singh
The paper "Operations research within UK healthcare: a review" provides an overview of the application of operations research (OR) in the UK healthcare sector. The review highlights the contribution of OR in improving efficiency, reducing costs, and enhancing patient outcomes in various areas of healthcare, such as hospital management, patient flow, resource allocation, and scheduling. The paper also discusses the challenges and opportunities in applying OR in healthcare, such as data availability, ethical considerations, and stakeholder engagement. Overall, the review provides insights into the potential of OR to drive innovation and improve healthcare delivery in the UK.
Presenting a published paper:
"Systematic review or scoping review? Guidance for authors when choosing between a systematic or scoping review
approach"
Role of Biostatistics in Clinical TrialsClinosolIndia
Biostatistics plays a pivotal role in the design, conduct, analysis, and interpretation of clinical trials. This field of statistics is indispensable in ensuring the scientific rigor and validity of clinical research. Here are key aspects of the role of biostatistics in clinical trials
Acetabularia Information For Class 9 .docxvaibhavrinwa19
Acetabularia acetabulum is a single-celled green alga that in its vegetative state is morphologically differentiated into a basal rhizoid and an axially elongated stalk, which bears whorls of branching hairs. The single diploid nucleus resides in the rhizoid.
Macroeconomics- Movie Location
This will be used as part of your Personal Professional Portfolio once graded.
Objective:
Prepare a presentation or a paper using research, basic comparative analysis, data organization and application of economic information. You will make an informed assessment of an economic climate outside of the United States to accomplish an entertainment industry objective.
Unit 8 - Information and Communication Technology (Paper I).pdfThiyagu K
This slides describes the basic concepts of ICT, basics of Email, Emerging Technology and Digital Initiatives in Education. This presentations aligns with the UGC Paper I syllabus.
Embracing GenAI - A Strategic ImperativePeter Windle
Artificial Intelligence (AI) technologies such as Generative AI, Image Generators and Large Language Models have had a dramatic impact on teaching, learning and assessment over the past 18 months. The most immediate threat AI posed was to Academic Integrity with Higher Education Institutes (HEIs) focusing their efforts on combating the use of GenAI in assessment. Guidelines were developed for staff and students, policies put in place too. Innovative educators have forged paths in the use of Generative AI for teaching, learning and assessments leading to pockets of transformation springing up across HEIs, often with little or no top-down guidance, support or direction.
This Gasta posits a strategic approach to integrating AI into HEIs to prepare staff, students and the curriculum for an evolving world and workplace. We will highlight the advantages of working with these technologies beyond the realm of teaching, learning and assessment by considering prompt engineering skills, industry impact, curriculum changes, and the need for staff upskilling. In contrast, not engaging strategically with Generative AI poses risks, including falling behind peers, missed opportunities and failing to ensure our graduates remain employable. The rapid evolution of AI technologies necessitates a proactive and strategic approach if we are to remain relevant.
Read| The latest issue of The Challenger is here! We are thrilled to announce that our school paper has qualified for the NATIONAL SCHOOLS PRESS CONFERENCE (NSPC) 2024. Thank you for your unwavering support and trust. Dive into the stories that made us stand out!
Francesca Gottschalk - How can education support child empowerment.pptxEduSkills OECD
Francesca Gottschalk from the OECD’s Centre for Educational Research and Innovation presents at the Ask an Expert Webinar: How can education support child empowerment?
Operation “Blue Star” is the only event in the history of Independent India where the state went into war with its own people. Even after about 40 years it is not clear if it was culmination of states anger over people of the region, a political game of power or start of dictatorial chapter in the democratic setup.
The people of Punjab felt alienated from main stream due to denial of their just demands during a long democratic struggle since independence. As it happen all over the word, it led to militant struggle with great loss of lives of military, police and civilian personnel. Killing of Indira Gandhi and massacre of innocent Sikhs in Delhi and other India cities was also associated with this movement.
Honest Reviews of Tim Han LMA Course Program.pptxtimhan337
Personal development courses are widely available today, with each one promising life-changing outcomes. Tim Han’s Life Mastery Achievers (LMA) Course has drawn a lot of interest. In addition to offering my frank assessment of Success Insider’s LMA Course, this piece examines the course’s effects via a variety of Tim Han LMA course reviews and Success Insider comments.
The French Revolution, which began in 1789, was a period of radical social and political upheaval in France. It marked the decline of absolute monarchies, the rise of secular and democratic republics, and the eventual rise of Napoleon Bonaparte. This revolutionary period is crucial in understanding the transition from feudalism to modernity in Europe.
For more information, visit-www.vavaclasses.com
8. the original Greenberg diagram a recent representation of the NIH model The Executive Committee has “the responsibility … to review the data analysis coming from the Coordinating Center and to prepare frequent reports to the participants, as well as annual reports to the National Heart Institute”
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13. Sequential (2X2) medical trial: Hodgkin’s Disease, Stanford Medical Center, 1967 The group methods replaced the 2X2 sequential methods first developped and used in the 1960s
23. CALGB 2006 The protocol lies at the core of the new style of practice
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27. II. What kind of institution is a DMC? DMCs are reflexive institutions.
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29. A typical DMC charter Informal reflexion and formal coding
30. The Guidance process i) 2001 Draft Guidance document issued ii) 2001 Public Meeting iii) 2006 Guidance document issued Forums for Reflexion
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32. should a DMC be allowed to change sample size? ‘ A clinical trial ... is not a fixed quantity. It’s almost like a living thing. It evolves; it changes; it can change. One of the obvious ways in which a clinical trial might need to be modified has to do with the sample size. When the sample size is calculated, different things are assumed about the rate in the control arm, the rate in the treatment arm. Those assumptions may or may not be valid. And it may turn out that the trial is underpowered and the sample size needs to be adjusted. A data monitoring committee, although it’s not easy, can grapple with this’. [Gregory Campbell, FDA meeting]
33. should a DMC be allowed to change sample size? ‘ [a DMC] is seeing data on efficacy and for it to have the ability and the right to change end points and to change crucial aspects of design I think can sacrifice the integrity of the design’. [Janet Wittes, FDA meeting] ‘ the unblinded data monitoring committee really can’t credibly change end point, sample size, subset plans or anything, any more than an unblinded sponsor could without at a minimum affecting alpha or introducing bias that we don’t know how to correct’. [Robert Temple, FDA meeting]
34. should a DMC be allowed to change sample size? ‘ Not all studies are confirmatory but those studies that are confirmatory, I’d like to be able to interpret them in that manner. It means ... I’d like to have a pre-specified hypothesis that I then confirm. At the same time, there can well be during the course of a long trial external information that could enlighten us as to what the hypothesis really ought to be. I actually don’t have a problem if I’m certain that it’s external data that leads to refinement and this is the essence of where this independence and separation enables or empowers the sponsor to have that flexibility’. [Thomas Fleming, FDA meeting]
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39. Does the independent staistician have the expertise? ‘ In the multicenter, cancer cooperative group setting … the trial data manager prepares the data for the interim analysis which is carried out by the trial statistician. Within this setting we feel that it is difficult for a completely independent third party to carry out the analysis for the following reasons: 1. They will not be as familiar with the trial or the data as the trial data manager and trial statistician and are thus more likely to make mistakes in the analysis. 2. With a large number of trials it becomes much more difficult both practically and financially to have the trial analyzed by a third party’. [Richard Sylvester, FDA Dockets]