Successful Randomized Trials

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Randomization in Clinical Trials

Author : William F. Rosenberger
Publisher : John Wiley & Sons
ISBN 13 : 1118742249
Total Pages : 284 pages
Book Rating : 4.1/5 (187 download)

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Book Synopsis Randomization in Clinical Trials by : William F. Rosenberger

Download or read book Randomization in Clinical Trials written by William F. Rosenberger and published by John Wiley & Sons. This book was released on 2015-11-23 with total page 284 pages. Available in PDF, EPUB and Kindle. Book excerpt: Praise for the First Edition “All medical statisticians involved in clinical trials should read this book…” - Controlled Clinical Trials Featuring a unique combination of the applied aspects of randomization in clinical trials with a nonparametric approach to inference, Randomization in Clinical Trials: Theory and Practice, Second Edition is the go-to guide for biostatisticians and pharmaceutical industry statisticians. Randomization in Clinical Trials: Theory and Practice, Second Edition features: Discussions on current philosophies, controversies, and new developments in the increasingly important role of randomization techniques in clinical trials A new chapter on covariate-adaptive randomization, including minimization techniques and inference New developments in restricted randomization and an increased focus on computation of randomization tests as opposed to the asymptotic theory of randomization tests Plenty of problem sets, theoretical exercises, and short computer simulations using SAS® to facilitate classroom teaching, simplify the mathematics, and ease readers’ understanding Randomization in Clinical Trials: Theory and Practice, Second Edition is an excellent reference for researchers as well as applied statisticians and biostatisticians. The Second Edition is also an ideal textbook for upper-undergraduate and graduate-level courses in biostatistics and applied statistics. William F. Rosenberger, PhD, is University Professor and Chairman of the Department of Statistics at George Mason University. He is a Fellow of the American Statistical Association and the Institute of Mathematical Statistics, and author of over 80 refereed journal articles, as well as The Theory of Response-Adaptive Randomization in Clinical Trials, also published by Wiley. John M. Lachin, ScD, is Research Professor in the Department of Epidemiology and Biostatistics as well as in the Department of Statistics at The George Washington University. A Fellow of the American Statistical Association and the Society for Clinical Trials, Dr. Lachin is actively involved in coordinating center activities for clinical trials of diabetes. He is the author of Biostatistical Methods: The Assessment of Relative Risks, Second Edition, also published by Wiley.

Field Trials of Health Interventions

Author : Peter G. Smith
Publisher : Oxford University Press, USA
ISBN 13 : 0198732864
Total Pages : 479 pages
Book Rating : 4.1/5 (987 download)

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Book Synopsis Field Trials of Health Interventions by : Peter G. Smith

Download or read book Field Trials of Health Interventions written by Peter G. Smith and published by Oxford University Press, USA. This book was released on 2015 with total page 479 pages. Available in PDF, EPUB and Kindle. Book excerpt: "IEA, International Epidemiological Association, Welcome Trust."

Complex Interventions in Health

Author : David A. Richards
Publisher : Routledge
ISBN 13 : 1134470568
Total Pages : 444 pages
Book Rating : 4.1/5 (344 download)

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Book Synopsis Complex Interventions in Health by : David A. Richards

Download or read book Complex Interventions in Health written by David A. Richards and published by Routledge. This book was released on 2015-04-17 with total page 444 pages. Available in PDF, EPUB and Kindle. Book excerpt: Health and human services currently face a series of challenges – such as aging populations, chronic diseases and new endemics – that require highly complex responses, and take place in multiple care environments including acute medicine, chronic care facilities and the community. Accordingly, most modern health care interventions are now seen as ‘complex interventions’ – activities that contain a number of component parts with the potential for interactions between them which, when applied to the intended target population, produce a range of possible and variable outcomes. This in turn requires methodological developments that also take into account changing values and attitudes related to the situation of patients’ receiving health care. The first book to place complex interventions within a coherent system of research enquiry, this work is designed to help researchers understand the research processes involved at each stage of developing, testing, evaluating and implementing complex interventions, and assist them to integrate methodological activities to produce secure, evidence-based health care interventions. It begins with conceptual chapters which set out the complex interventions framework, discuss the interrelation between knowledge development and evidence, and explore how mixed methods research contributes to improved health. Structured around the influential UK Medical Research Council guidance for use of complex interventions, four sections, each comprised of bite-sized chapters written by multidisciplinary experts in the area, focus on: - Developing complex interventions - Assessing the feasibility of complex interventions and piloting them - Evaluating complex interventions - Implementing complex interventions. Accessible to students and researchers grappling with complex interventions, each substantive chapter includes an introduction, bulleted learning objectives, clinical examples, a summary and further reading. The perspectives of various stakeholders, including patients, families and professionals, are discussed throughout as are the economic and ethical implications of methods. A vital companion for health research, this book is suitable for readers from multidisciplinary disciplines such as medical, nursing, public health, health services research, human services and allied healthcare backgrounds.

Small Clinical Trials

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 9780309171144
Total Pages : 222 pages
Book Rating : 4.1/5 (711 download)

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Book Synopsis Small Clinical Trials by : Institute of Medicine

Download or read book Small Clinical Trials written by Institute of Medicine and published by National Academies Press. This book was released on 2001-01-01 with total page 222 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical trials are used to elucidate the most appropriate preventive, diagnostic, or treatment options for individuals with a given medical condition. Perhaps the most essential feature of a clinical trial is that it aims to use results based on a limited sample of research participants to see if the intervention is safe and effective or if it is comparable to a comparison treatment. Sample size is a crucial component of any clinical trial. A trial with a small number of research participants is more prone to variability and carries a considerable risk of failing to demonstrate the effectiveness of a given intervention when one really is present. This may occur in phase I (safety and pharmacologic profiles), II (pilot efficacy evaluation), and III (extensive assessment of safety and efficacy) trials. Although phase I and II studies may have smaller sample sizes, they usually have adequate statistical power, which is the committee's definition of a "large" trial. Sometimes a trial with eight participants may have adequate statistical power, statistical power being the probability of rejecting the null hypothesis when the hypothesis is false. Small Clinical Trials assesses the current methodologies and the appropriate situations for the conduct of clinical trials with small sample sizes. This report assesses the published literature on various strategies such as (1) meta-analysis to combine disparate information from several studies including Bayesian techniques as in the confidence profile method and (2) other alternatives such as assessing therapeutic results in a single treated population (e.g., astronauts) by sequentially measuring whether the intervention is falling above or below a preestablished probability outcome range and meeting predesigned specifications as opposed to incremental improvement.

Randomized Controlled Trials

Author : Alehandro R. Jadad
Publisher : John Wiley & Sons
ISBN 13 : 1405132663
Total Pages : 170 pages
Book Rating : 4.4/5 (51 download)

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Book Synopsis Randomized Controlled Trials by : Alehandro R. Jadad

Download or read book Randomized Controlled Trials written by Alehandro R. Jadad and published by John Wiley & Sons. This book was released on 2007-07-23 with total page 170 pages. Available in PDF, EPUB and Kindle. Book excerpt: Randomized controlled trials are one of the most powerful and revolutionary tools of research. This book is a convenient and accessible description of the underlying principles and practice of randomized controlled trials and their role in clinical decision-making. Structured in a jargon-free question-and-answer format, each chapter provides concise and understandable information on a different aspect of randomized controlled trials, from the basics of trial design and terminology to the interpretation of results and their use in driving evidence-based medicine. The authors end each chapter with their musings, going beyond the evidence or citations, and sometimes even beyond orthodox correctness to share their thoughts and concerns about different aspects of randomized controlled trials, and their role within the health system. Updated to include insights from the last decade, this second edition challenges over-reliance on randomized controlled trials by debating their strengths and limitations and discussing their optimal use in modern healthcare. It also includes a new and increasingly relevant chapter on the ethics of randomized trials. World renowned writers and thinkers Drs Jadad and Enkin bring you this invaluable book for busy health professionals who wish to understand the theory of randomized controlled trials and their influence on clinical, research or policy decisions.

Validity and Inter-Rater Reliability Testing of Quality Assessment Instruments

Author : U. S. Department of Health and Human Services
Publisher : CreateSpace
ISBN 13 : 9781484077146
Total Pages : 108 pages
Book Rating : 4.0/5 (771 download)

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Book Synopsis Validity and Inter-Rater Reliability Testing of Quality Assessment Instruments by : U. S. Department of Health and Human Services

Download or read book Validity and Inter-Rater Reliability Testing of Quality Assessment Instruments written by U. S. Department of Health and Human Services and published by CreateSpace. This book was released on 2013-04-09 with total page 108 pages. Available in PDF, EPUB and Kindle. Book excerpt: The internal validity of a study reflects the extent to which the design and conduct of the study have prevented bias(es). One of the key steps in a systematic review is assessment of a study's internal validity, or potential for bias. This assessment serves to: (1) identify the strengths and limitations of the included studies; (2) investigate, and potentially explain heterogeneity in findings across different studies included in a systematic review; and (3) grade the strength of evidence for a given question. The risk of bias assessment directly informs one of four key domains considered when assessing the strength of evidence. With the increase in the number of published systematic reviews and development of systematic review methodology over the past 15 years, close attention has been paid to the methods for assessing internal validity. Until recently this has been referred to as “quality assessment” or “assessment of methodological quality.” In this context “quality” refers to “the confidence that the trial design, conduct, and analysis has minimized or avoided biases in its treatment comparisons.” To facilitate the assessment of methodological quality, a plethora of tools has emerged. Some of these tools were developed for specific study designs (e.g., randomized controlled trials (RCTs), cohort studies, case-control studies), while others were intended to be applied to a range of designs. The tools often incorporate characteristics that may be associated with bias; however, many tools also contain elements related to reporting (e.g., was the study population described) and design (e.g., was a sample size calculation performed) that are not related to bias. The Cochrane Collaboration recently developed a tool to assess the potential risk of bias in RCTs. The Risk of Bias (ROB) tool was developed to address some of the shortcomings of existing quality assessment instruments, including over-reliance on reporting rather than methods. Several systematic reviews have catalogued and critiqued the numerous tools available to assess methodological quality, or risk of bias of primary studies. In summary, few existing tools have undergone extensive inter-rater reliability or validity testing. Moreover, the focus of much of the tool development or testing that has been done has been on criterion or face validity. Therefore it is unknown whether, or to what extent, the summary assessments based on these tools differentiate between studies with biased and unbiased results (i.e., studies that may over- or underestimate treatment effects). There is a clear need for inter-rater reliability testing of different tools in order to enhance consistency in their application and interpretation across different systematic reviews. Further, validity testing is essential to ensure that the tools being used can identify studies with biased results. Finally, there is a need to determine inter-rater reliability and validity in order to support the uptake and use of individual tools that are recommended by the systematic review community, and specifically the ROB tool within the Evidence-based Practice Center (EPC) Program. In this project we focused on two tools that are commonly used in systematic reviews. The Cochrane ROB tool was designed for RCTs and is the instrument recommended by The Cochrane Collaboration for use in systematic reviews of RCTs. The Newcastle-Ottawa Scale is commonly used for nonrandomized studies, specifically cohort and case-control studies.

Handbook of Statistics in Clinical Oncology

Author : John Crowley
Publisher : CRC Press
ISBN 13 : 142002776X
Total Pages : 642 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Handbook of Statistics in Clinical Oncology by : John Crowley

Download or read book Handbook of Statistics in Clinical Oncology written by John Crowley and published by CRC Press. This book was released on 2005-12-01 with total page 642 pages. Available in PDF, EPUB and Kindle. Book excerpt: A compendium of cutting-edge statistical approaches to solving problems in clinical oncology, Handbook of Statistics in Clinical Oncology, Second Edition focuses on clinical trials in phases I, II, and III, proteomic and genomic studies, complementary outcomes and exploratory methods. Cancer Forum called the first edition a

Cluster Randomised Trials

Author : Richard J. Hayes
Publisher : CRC Press
ISBN 13 : 1315353237
Total Pages : 466 pages
Book Rating : 4.3/5 (153 download)

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Book Synopsis Cluster Randomised Trials by : Richard J. Hayes

Download or read book Cluster Randomised Trials written by Richard J. Hayes and published by CRC Press. This book was released on 2017-07-06 with total page 466 pages. Available in PDF, EPUB and Kindle. Book excerpt: Cluster Randomised Trials, Second Edition discusses the design, conduct, and analysis of trials that randomise groups of individuals to different treatments. It explores the advantages of cluster randomisation, with special attention given to evaluating the effects of interventions against infectious diseases. Avoiding unnecessary mathematical detail, the book covers basic concepts underlying the use of cluster randomisation, such as direct, indirect, and total effects. In the time since the publication of the first edition, the use of cluster randomised trials (CRTs) has increased substantially, which is reflected in the updates to this edition. There are greatly expanded sections on randomisation, sample size estimation, and alternative designs, including new material on stepped wedge designs. There is a new section on handling ordinal outcome data, and an appendix with descriptions and/or generating code of the example data sets. Although the book mainly focuses on medical and public health applications, it shows that the rigorous evidence of intervention effects provided by CRTs has the potential to inform public policy in a wide range of other areas. The book encourages readers to apply the methods to their own trials, reproduce the analyses presented, and explore alternative approaches.

Designing Randomised Trials in Health, Education and the Social Sciences

Author : D. Torgerson
Publisher : Springer
ISBN 13 : 0230583997
Total Pages : 226 pages
Book Rating : 4.2/5 (35 download)

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Book Synopsis Designing Randomised Trials in Health, Education and the Social Sciences by : D. Torgerson

Download or read book Designing Randomised Trials in Health, Education and the Social Sciences written by D. Torgerson and published by Springer. This book was released on 2008-03-13 with total page 226 pages. Available in PDF, EPUB and Kindle. Book excerpt: The book focuses on the design of rigorous trials rather than their statistical underpinnings, with chapters on: pragmatic designs; placebo designs; preference approaches; unequal allocation; economics; analytical approaches; randomization methods. It also includes a detailed description of randomization procedures and different trial designs.

A Practical Guide to Cluster Randomised Trials in Health Services Research

Author : Sandra Eldridge
Publisher : John Wiley & Sons
ISBN 13 : 0470510471
Total Pages : 299 pages
Book Rating : 4.4/5 (75 download)

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Book Synopsis A Practical Guide to Cluster Randomised Trials in Health Services Research by : Sandra Eldridge

Download or read book A Practical Guide to Cluster Randomised Trials in Health Services Research written by Sandra Eldridge and published by John Wiley & Sons. This book was released on 2012-02-20 with total page 299 pages. Available in PDF, EPUB and Kindle. Book excerpt: Cluster randomised trials are trials in which groups (or clusters) of individuals are randomly allocated to different forms of treatment. In health care, these trials often compare different ways of managing a disease or promoting healthy living, in contrast to conventional randomised trials which randomise individuals to different treatments, classically comparing new drugs with a placebo. They are increasingly common in health services research. This book addresses the statistical, practical, and ethical issues arising from allocating groups of individuals, or clusters, to different interventions. Key features: Guides readers through the stages of conducting a trial, from recruitment to reporting. Presents a wide range of examples with particular emphasis on trials in health services research and primary care, with both principles and techniques explained. Topics are specifically presented in the order in which investigators think about issues when they are designing a trial. Combines information on the latest developments in the field together with a practical guide to the design and implementation of cluster randomised trials. Explains principles and techniques through numerous examples including many from the authors own experience. Includes a wide range of references for those who wish to read further. This book is intended as a practical guide, written for researchers from the health professions including doctors, psychologists, and allied health professionals, as well as statisticians involved in the design, execution, analysis and reporting of cluster randomised trials. Those with a more general interest will find the plentiful examples illuminating.

Randomized Controlled Trials

Author : Phyllis Solomon
Publisher : Oxford University Press
ISBN 13 : 9780199715541
Total Pages : 224 pages
Book Rating : 4.7/5 (155 download)

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Book Synopsis Randomized Controlled Trials by : Phyllis Solomon

Download or read book Randomized Controlled Trials written by Phyllis Solomon and published by Oxford University Press. This book was released on 2009-02-02 with total page 224 pages. Available in PDF, EPUB and Kindle. Book excerpt: Randomized controlled trials (RCTs) are considered by many researchers and providers to be the gold standard of health and social service effectiveness research. However, there exist scant resources that deal with the complex nature of designing and implementing RCTs in community-based settings. This clearly written pocket guide provides researchers and social service practitioners insight into each step of an RCT. The goal of this text is to enable readers to understand, design, and implement a community-based RCT. From the initial stage of planning the RCT and developing its conceptual foundations through implementation, the authors provide a wealth of detail and case studies from social work practice research that assist readers to comprehend the detailed information provided. Accessible, concrete advice is woven throughout the text and tackles the many design and implementation challenges that arise in community practice settings. The importance of utilizing a mix of qualitative and quantitative methods is encouraged due to the intricate nature of RCT research in community-based environments. Through utilizing practical case examples, this pocket guide reviews the essentials of RCTs in a manner that will appeal to researchers, practitioners and students alike who are seeking the necessary tools to build the empirical knowledge base for community-based psychosocial interventions for social work.

Modern Adaptive Randomized Clinical Trials

Author : Oleksandr Sverdlov
Publisher : CRC Press
ISBN 13 : 1482239892
Total Pages : 536 pages
Book Rating : 4.4/5 (822 download)

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Book Synopsis Modern Adaptive Randomized Clinical Trials by : Oleksandr Sverdlov

Download or read book Modern Adaptive Randomized Clinical Trials written by Oleksandr Sverdlov and published by CRC Press. This book was released on 2015-06-30 with total page 536 pages. Available in PDF, EPUB and Kindle. Book excerpt: Is adaptive randomization always better than traditional fixed-schedule randomization? Which procedures should be used and under which circumstances? What special considerations are required for adaptive randomized trials? What kind of statistical inference should be used to achieve valid and unbiased treatment comparisons following adaptive random

Pragmatic Randomized Clinical Trials

Author : Cynthia J. Girman
Publisher : Academic Press
ISBN 13 : 0128176644
Total Pages : 500 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis Pragmatic Randomized Clinical Trials by : Cynthia J. Girman

Download or read book Pragmatic Randomized Clinical Trials written by Cynthia J. Girman and published by Academic Press. This book was released on 2021-04-08 with total page 500 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pragmatic Randomized Clinical Trials Using Primary Data Collection and Electronic Health Records addresses the practical aspects and challenges of the design, implementation, and dissemination of pragmatic randomized trials, also sometimes referred to as practical or hybrid randomized trials. While less restrictive and more generalizable than traditional randomized controlled trials, such trials have specific challenges which are addressed in this book. The book contains chapters encompassing common designs along with advantages and limitations of such designs, analytic aspects in planning trials and estimating sample size, and how to use patient partners to help design and operationalize pragmatic randomized trials. Pragmatic trials conducted using primary data collection and trials embedded in electronic health records - including electronic medical records and administrative insurance claims - are addressed. This comprehensive resource is valuable not only for pharmacoepidemiologists, biostatisticians and clinical researchers, but also across the biomedical field for those who are interested in applying pragmatic randomized clinical trials in their research. Addresses typical designs and challenges of pragmatic randomized clinical trials (pRCTs) Encompasses analytic aspects of such trials Discusses real cases on operational challenges in launching and conducting pRCTs in electronic health records

How to Design, Analyse and Report Cluster Randomised Trials in Medicine and Health Related Research

Author : Michael J. Campbell
Publisher : John Wiley & Sons
ISBN 13 : 1119992028
Total Pages : 266 pages
Book Rating : 4.1/5 (199 download)

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Book Synopsis How to Design, Analyse and Report Cluster Randomised Trials in Medicine and Health Related Research by : Michael J. Campbell

Download or read book How to Design, Analyse and Report Cluster Randomised Trials in Medicine and Health Related Research written by Michael J. Campbell and published by John Wiley & Sons. This book was released on 2014-05-27 with total page 266 pages. Available in PDF, EPUB and Kindle. Book excerpt: A complete guide to understanding cluster randomised trials Written by two researchers with extensive experience in the field, this book presents a complete guide to the design, analysis and reporting of cluster randomised trials. It spans a wide range of applications: trials in developing countries, trials in primary care, trials in the health services. A key feature is the use of R code and code from other popular packages to plan and analyse cluster trials, using data from actual trials. The book contains clear technical descriptions of the models used, and considers in detail the ethics involved in such trials and the problems in planning them. For readers and students who do not intend to run a trial but wish to be a critical reader of the literature, there are sections on the CONSORT statement, and exercises in reading published trials. Written in a clear, accessible style Features real examples taken from the authors’ extensive practitioner experience of designing and analysing clinical trials Demonstrates the use of R, Stata and SPSS for statistical analysis Includes computer code so the reader can replicate all the analyses Discusses neglected areas such as ethics and practical issues in running cluster randomised trials How to Design, Analyse and Report Cluster Randomised Trials in Medicine and Health Related Research provides an excellent reference tool and can be read with profit by statisticians, health services researchers, systematic reviewers and critical readers of cluster randomised trials.

Good Research Practice in Non-Clinical Pharmacology and Biomedicine

Author : Anton Bespalov
Publisher : Springer Nature
ISBN 13 : 3030336565
Total Pages : 424 pages
Book Rating : 4.0/5 (33 download)

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Book Synopsis Good Research Practice in Non-Clinical Pharmacology and Biomedicine by : Anton Bespalov

Download or read book Good Research Practice in Non-Clinical Pharmacology and Biomedicine written by Anton Bespalov and published by Springer Nature. This book was released on 2020-01-01 with total page 424 pages. Available in PDF, EPUB and Kindle. Book excerpt: This open access book, published under a CC BY 4.0 license in the Pubmed indexed book series Handbook of Experimental Pharmacology, provides up-to-date information on best practice to improve experimental design and quality of research in non-clinical pharmacology and biomedicine.

Pharmacoepidemiology

Author : Brian L. Strom
Publisher : John Wiley & Sons
ISBN 13 : 1119413419
Total Pages : 1220 pages
Book Rating : 4.1/5 (194 download)

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Book Synopsis Pharmacoepidemiology by : Brian L. Strom

Download or read book Pharmacoepidemiology written by Brian L. Strom and published by John Wiley & Sons. This book was released on 2019-12-16 with total page 1220 pages. Available in PDF, EPUB and Kindle. Book excerpt: This classic, field-defining textbook, now in its sixth edition, provides the most comprehensive guidance available for anyone needing up-to-date information in pharmacoepidemiology. This edition has been fully revised and updated throughout and continues to provide a rounded view on all perspectives from academia, industry and regulatory bodies, addressing data sources, applications and methodologies with great clarity.

Randomized Control Trials in the Field of Development

Author : Florent Bédécarrats
Publisher : Oxford University Press, USA
ISBN 13 : 0198865368
Total Pages : 442 pages
Book Rating : 4.1/5 (988 download)

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Book Synopsis Randomized Control Trials in the Field of Development by : Florent Bédécarrats

Download or read book Randomized Control Trials in the Field of Development written by Florent Bédécarrats and published by Oxford University Press, USA. This book was released on 2020 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: In October 2019, Abhijit Banerjee, Esther Duflo, and Michael Kremer jointly won the 51st Sveriges Riksbank Prize in Economic Sciences in Memory of Alfred Nobel for their experimental approach to alleviating global poverty. But what is the exact scope of their experimental method, known as randomized control trials (RCTs)? Which sorts of questions are RCTs able to address and which do they fail to answer? The first of its kind, Randomized Control Trials in the Field of Development: A Critical Perspective provides answers to these questions, explaining how RCTs work, what they can achieve, why they sometimes fail, how they can be improved and why other methods are both useful and necessary. Bringing together leading specialists in the field from a range of backgrounds and disciplines (economics, econometrics, mathematics, statistics, political economy, socioeconomics, anthropology, philosophy, global health, epidemiology, and medicine), it presents a full and coherent picture of the main strengths and weaknesses of RCTs in the field of development. Looking beyond the epistemological, political, and ethical differences underlying many of the disagreements surrounding RCTs, it explores the implementation of RCTs on the ground, outside of their ideal theoretical conditions and reveals some unsuspected uses and effects, their disruptive potential, but also their political uses. The contributions uncover the implicit worldview that many RCTs draw on and disseminate, and probe the gap between the method's narrow scope and its success, while also proposing improvements and alternatives. Without disputing the contribution of RCTs to scientific knowledge, Randomized Control Trials in the Field of Development warns against the potential dangers of their excessive use, arguing that the best use for RCTs is not necessarily that which immediately springs to mind. Written in plain language, this book offers experts and laypeople alike a unique opportunity to come to an informed and reasoned judgement on RCTs and what they can bring to development.