Clinical Researchers

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Brief Guidelines for Methods and Statistics in Medical Research

Abstract

Research requires sound methodology. It begins by properly identify good research topic, intensive background literatures and clear concept. Objectives are written with SMART criteria. Relevant variables are identified, defined and planned on how they are to be collected in standard manner. Statistical analyses

should then be planned in great detail.

Keywords Research methodology Research design Sampling Sample size

Data collection Validity and reliability Quality of data What is research? Literally research means a careful or diligent search; systematic inquiries, investigations or experimentations to discover or to prove theories. In medicine, research is initiated to measure magnitude of diseases, maybe in population or institution; or even among a specific group of people. Research is also conducted to prove how good the new drugs, methods or any invention when compared to the existing ones. Research helps policy makers to design and plan strategies based on best available evidence.

The most important requirement to start a research is to know why we would like to conduct one. We may do research to:

• decide the best treatment for patient,

• measure prevalence of a disease in the community,

• determine risk factors for common health problem,

• describe health seeking behaviour in a population,

• prove that the new drug is better than the old one; or for many other reasons.

Academic Writing

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Writing is an integral part of the process of research. It also facilitates success in academics. It is not enough to be smart and knowledgeable; we have to demonstrate our knowledge and insights through writing whether we are students or scholars.Otherwise we would be like wild flowers—perhaps the most beautiful on earth with exquisite scent, but unseen, unsmelt and unsung.

Academic Writing is aimed at MBA students, MPhil and PhD scholars, and young faculty in management and behavioural sciences. The nudge for writing this book came from our graduate and doctoral students in the field of management and participants in faculty development programmes—their research papers and other written assignments, to be precise. Some of these students are among the best in the country, perhaps in the world. But their writing often lets them down.

Meet your Patient Recruitment & Enrollment Goals

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Recruiting and enrolling patients for clinical trials is often a long and difficult process. Nearly 80% of clinical trials fail to meet enrollment timelines.

This eBook explores common challenges in patient recruitment and retention and presents 10 tips to successful recruitment and retention in clinical trials.

Enrollment planning
Finding the right patients
Keys to retention

Basic statistic for resaerch

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Statistics is a very broad subject, with applications in a vast number of different fields. In enerally one can say that statistics is the methodology for collecting, analyzing, interpreting and drawing conclusions from information. Putting it in other words, statistics is the methodology which scientists and mathematicians have developed for interpreting and drawing conclusions from collected data. Everything that deals even remotely with the collection, processing, interpretation and presentation of data belongs to the domain of statistics, and so does the detailed planning of that precedes all these activities

Biostatistics in Clinical Trials

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Statistics is the science of collecting, summarizing, presenting and interpreting data, and of using them to estimate the magnitude of associations and test hypotheses. It has a central role in medical investigations. Not only does it provide a way of organizing information on a wider and more formal basis than relying on the exchange of anecdotes and personal experience, it takes into account the intrinsic variation inherent in most biological processes. For example, not only does blood pressure differ from person to person, but in the same person it also varies from day to day and from hour to hour. It is the interpretation of data in the presence of such variability that lies at the heart of statistics. Thus, in investigating morbidity associated with a particular stressful occupation, statistical methods would be needed to assess whether an observed average blood pressure above that of the general population could simply be due to chance variations or whether it represents a real indication of an occupational health risk

Maintaining health and treating illness through regular physical activity

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The World Health Organisation has identified a lack of physical activity as the fourth leading risk factor for global mortality, being directly implicated in 6% of deaths worldwide. Publications such as “the five year forward view”, “20/20 vision”, and the “Christie Commission” agree that increased prioritisation of effective, person-centred preventative medicine is needed to allow people to live longer, healthier lives in their communities both in the UK and worldwide.

Regular physical activity can improve academic attainment and healthy development in children and young people, improves productivity and health outcomes in young and middle aged adults, whilst maintaining functional independence in older adults. Regular physical activity helps maintain good mental and physical health, and helps prevent over 40 chronic diseases.
Physical inactivity is a highly prevalent and major public health challenge in the 21st entury.While progress has been made, and must be sustained in relation to smoking, a significant increase in the pace and scale of efforts to increase physical activity is required.

Conducting GCP-compliant Clinical Research( book to Read)

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The overall aim of this work is to provide a reference book which describes the general framework for conducting GCP compliant clinical research, particularly pharmaceutical industry clinical research. Hopefully, it is written in simple enough language so that it is readable to those who are new to the business: however, we have also included many examples from our years of practice to sustain the interest of a more experienced group. Pharmaceutical industry personnel (e.g. monitors, data management personnel, statisticians, medical advisers, and study medication or device suppliers from both sponsors and CROs) will find many helpful hints and examples of how the situation can go awry.

Ethical Conduct for Research Involving Humans.Canadian TCPS2

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The second edition of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans was launched in December 2010. TCPS 2, as it is commonly known, updated and expanded the original (1998) version of TCPS. The Panel on Research Ethics (PRE) and the Secretariat on Responsible Conduct of Research that supports PRE, strive to ensure that TCPS 2 is current and that the guidance it provides is as clear as possible. In this, they have always received the full support of the federal research agencies (CIHR, NSERC and SSHRC) that are jointly responsible for the TCPS, and for PRE and the Secretariat.

This revised version of TCPS 2 reflects the efforts of PRE and the Secretariat since the launch of TCPS 2 to achieve those goals. Together, they have addressed areas requiring clarification and responded to the evolution of issues that arise in research involving humans. These efforts are informed by the feedback we received from the research community and from those whose professional focus is research ethics. Community engagement provides an invaluable source of information for PRE and the Secretariat, whether through our interpretation service, our speaking engagements at regional and national meetings, or our public consultation on the proposed changes that led to this version of TCPS 2 . It is our hope that these revisions make TCPS 2 a more useful resource for researchers and, therefore, a more effective instrument for the protection of research participants.

Essentials of Clinical Research

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To answer many of their clinical questions, health care practitioners need access to reports of original research. This requires the reader to critically appraise the design, conduct, and analysis of each study and subsequently interpret the results. This fi rst chapter reviews some of the key historical developments that have led to the current paradigms used in clinical research, such as the concept of randomization, blinding (masking) and, placebo-controls.

Conducting Clinical Research

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Why Read This Book?

A View from the Trenches I offer a unique perspective, having experienced research from a variety of angles. I have participated in clinical trials since college and have been a patient in a clinical research center. I conducted bench and clinical research during my infectious disease fellowship, for which I designed and oversaw my first clinical trial (with mentoring, of course). In all, I have had over 20 years experience in conducting clinical trials. As background, I am a physician specializing in internal medicine with a subspecialty in infectious diseases. My initial medical training was at the University of Maryland, where the caliber of the infectious disease faculty was topnotch and the enthusiasm contagious. Infectious diseases, a specialty that spans all ages of patients and that involves being a sleuth and puzzling things out, fascinated me. When Memorial Hospital recruited me to practice in Cumberland, Maryland, there was no infectious disease specialist on the eastern side of the Appalachian Mountains within almost 150 miles.

The Elements of Success Conducting Cancer Clinical Trials A Guide

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In June 2005, The Lewin Group, in partnership with Lovett-Collins Associates, was commissioned by C-Change™ to conduct a study to determine the cost and time expenditures of cancer clinical trials. The Lewin Group published these findings and elements of success for cancer clinical trials in a document titled, “A Guidance Document for Implementing Effective Cancer Clinical Trials, Version 1.2.

” http://www.c- changetogether.org/about_ndc/newsroom/default.asp 1

The following year, based on input from the Summit on Clinical Trials, C-Change and the Coalition of Cancer Cooperative Groups commissioned The Lewin Group, again in partnership with Lovett-Collins Associates, to produce two targeted follow-up documents: a policy document that summarizes the current economic environment of cancer clinical trials for policy makers; and a web-based resource and guidance document on how to conduct clinical trials for use by clinical trial personnel.

ADVANCING MATERIALS RESEARCH

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ADVANCING MATERIALS RESEARCH

National Academy of Engineering National Academy of Sciences

with the participation of the National Materials Advisory Board and the

Solid State Sciences Committee of the National Research Council

The field of materials research has an extended past as well as a long and promising future. As an area of human technical endeavor it is as old as Homo faber—the first member of our species to seek a stone or piece of wood to help accomplish a difficult task. The field came a long way as an empirical art in the hands of successive generations of individuals who sought to reach out ever further in helping their local societies develop a better physical relationship with the surrounding world. The edge of a stone sharpened by flaking was better for cutting or scraping than a typical natural stone. Flint and obsidian had great advantages over the more common fieldstone. A hafted stone hammer could be more effective in certain situations than a stone merely held in the hand. Copper,and particularly bronze, was less brittle and more malleable than stone.Moreover, it was learned that the metals could be melted and cast into form. Iron eventually proved better than bronze, and was much more available than copper and tin once one learned to reduce its ores with carbon, although it was probably first used in the relatively rare meteoric form—“skystone” to the ancients.

Perhaps what is most significant about materials research throughout its history is that, in parallel with the development of social organization and advances in the art of language, it tended to be a major limiting factor in determining the rate at which civilization could advance. The effectiveness of

equipment of all kinds is conditioned in substantial part by the materials of which it is made. The nature and quality of materials in a device are as important as the ingenuity with which it is designed. Moreover, improvements in equipment have increased working efficiency and permitted greater freedom in society to promote both the expansion of population and the degree of specialization of those engaged in arts, crafts, and the management

Group Recruitment to Improve Clinical Study Enrollment and Retention

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Obtaining informed consent is an essential step in enrolling patients in clinical research studies. Traditionally, informed consent is obtained individually, person by person. Despite this time-consuming, personalized process, studies of informed consent consistently report low levels of comprehension. A modified process, “group recruitment,” offers the potential to improve comprehension, reduce the time required by study personnel, and also increase study participant engagement and retention. The benefits of group recruitment derive from three features: First, because information is presented to a group, it is feasible to present more information than can, as a practical matter, be presented individually. Second, during the group process, individuals share questions and concerns, helping patients feel more confident of a decision to participate. Third, patients bond with the group, so they feel more engaged in the study and are more likely to continue to the end.

Small Clinical Trials: Issues and Challenges

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he design and conduct of any type of clinical trial requires three considerations: first, the study should examine valuable and important biomedical research questions; second, it must be based on a rigorous methodology that can answer a specific research question being asked; and third, it must be based on a set of ethical considerations, adherence to which minimizes risks to individuals. Whenever possible standard trial designs should be used in clinical trials. Moreover, investigators should strive to design clinical trials that contain adequate statistical power. However, there are times when the number of experimental subjects is unavoidably small. For example, the rapid progress that is occurring in a variety of areas of science (e.g. biotechnology, organ transplantation, gene therapy, cellular therapies, bioartificial organs, and designer genes tailored to an individual) has resulted in the need for clinical trials with small numbers of participants and new approaches to optimization of the design and analysis of clinical trials when the number of experimental participants (the sample size) in unavoidably small. Clinical trials with small numbers of participants, however, must address broad sets of issues different from those that must be addressed in trials with large numbers of participants. It is in those circumstances of trials with small sample sizes that approaches to optimization of the study design and data interpretation pose greater challenges. Copyright © National Academy of Sciences. All rights reserved. Small Clinical Trials: Issues and Challenges http://www.nap.edu/catalog/10078.html x PREFACE Clinical trials involving astronauts share characteristics with clinical trials of the new technologies mentioned above, as astronauts comprise a population with small numbers of subjects, and many variables that affect this group during space travel cannot be controlled on Earth. However, interventions that prevent potentially life-threatening conditions such as accelerated bone mineral density loss on long space missions must be explored if long missions in space are to be successful. Therefore, the National Aeronautics and Space Administration (NASA) asked the Institute of Medicine (IOM) to convene a panel of experts to recommend optimal approaches to the design, implementation, and evaluation of outcomes in clinical trials with small numbers of participants. NASA commissioned this fast-track study because the opportunity to plan for the next clinical trial during a space mission was rapidly approaching and important questions needed to be answered. A group of experts in statistics, clinical research study design, epidemiology, and pharmacology made a major effort to prepare what I believe will be a widely useful report. Robert Gibbons, a biostatistician and liaison from the IOM Board on Health Sciences Policy, participated throughout the study as a full committee member. A centerpiece of the committee’s activity was an invitational workshop. Experts from the United States and Canada spent a full day providing additional information and expertise to the committee during the invitational workshop discussing future directions for small clinical trials with small numbers of participants. Their efforts were particularly important in helping the committee prepare this report. After careful consideration the committee developed recommendations for approaching the issues and challenges inherent in clinical trials with small sample sizes. Moreover, the design and implementation of future research in this newly developing area of clinical investigation will improve the ability of investigators to evaluate outcomes efficiently and in a cost-effective manner to allow advances in medicine to be available to patients with life-threatening diseases in an efficient manner. Finally, the IOM staff, led by Charles Evans, contributed significantly to the final outcome. We owe a tremendous gratitude to Kathi Hanna, a highly skilled science writer, and to Veronica Schreiber, the research assistant on the project, for their untiring efforts and assistance to the committee throughout all phases of the study.

Suzanne T. Ildstad
Committee Chai