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Fundamentals Of Randomized Controlled Trials

机译：随机对照试验基础

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The randomized controlled trial (RCT) is one of the simplest but most powerful tools of research. It is a form of study or scientific experiment in which people are allocated at random to receive one of several clinical interventions. These experiments are most commonly used in testing the safety and efficacy of any therapeutic or health care procedures. Preparing the protocol, specifying the methods of improving the transparency and validity of reporting the results of RCT’s and submitting for ethical review are basic prerequisites. Randomization reduces the risk of serious imbalance in important unknown as well as known factors that could influence the clinical course of the participants. Methods of Randomization include use of a table of random numbers, computer programs and tossing a coin etc. Apart from randomization, bias can be reduced by allocation concealment, blinding and minimizing the loss to follow. The basic study designs are concurrent parallel type, cross over type and factorial design. Other types include mega trials, sequential trials, fixed trials, explanatory and pragmatic trials. Valid inferences depend on how well the investigator designed, conducted and reported various procedures to minimize bias in the trial.The steps involved in conducting an RCT are selecting the reference population, selecting the experimental or study population, obtaining informed consent, randomization into treatment and control groups, application of intervention, follow up and final assessment of the outcome. INTRODUCTION Randomized Controlled Trial (RCT) is a type of scientific experiment or a form of clinical trial most commonly used in testing the safety and effectiveness of health care services or preventive or therapeutic procedures. [1]In recent decades, modern medicine has been blessed with a pharmaceutical armamentarium that is much more powerful than it had before. A major factor for such rapid advance has been the development and refinement of the clinical research method known as the RCT. A clinical trial is defined as a prospective scientific experiment that involves human subjects in whom an intervention is initiated for the evaluation of a therapeutic procedure.[2] In an RCT, each patient is assigned to receive a specific treatment intervention by a chance mechanism.These studies are the underlying basis for what is currently called “evidence-based medicine”. Nothing more clearly indicates the key role of an RCT in modern clinical research than the placement of this specific research method at the top of the list of levels of evidence in evidence-based medicine.[3]RCT, also known as true experiments or intervention studies, are considered to be the gold standard research design for demonstrating a cause-and-effect relationship between an intervention and an outcome. Results of an RCT are more definitive than any other type of clinical research information.RCTs can be classified according to the different aspects of intervention evaluated. These include explanatory or pragmatic trials, efficacy or effectiveness trials and Phase 1, 2, 3 & 4 trials.[4]We present here an outline of the fundamental principles of RCTs. IMPORTANT TERMS IN RCT The people who take part in RCTs (the ‘study population’) are called ‘participants’. Participants can be patients, healthy volunteers, relatives of patients, members of the general public, communities, or institutions. The people who design and carry out the study and analyze the results are called the ‘investigators.’ For example, if an investigator, say `A` and his colleagues are conducting a study in which patients with essential hypertension who are randomized to receive either a beta-blocker (or, say `drug X`) and a newly marketed drug, `Y`, say angiotensin receptor blocker (ARB), the `A` and his colleagues would be the investigators; the participants are the patients withessential hypertension; and the interventions are drug X and drug Y.RCTs usually try to measure and compare
机译：随机对照试验（RCT）是最简单但功能最强大的研究工具之一。这是一种研究或科学实验的形式，其中随机分配人们以接受几种临床干预措施之一。这些实验最常用于测试任何治疗或保健程序的安全性和有效性。准备协议，指定提高报告RCT结果的透明度和有效性以及提交道德审查的方法是基本的先决条件。随机化可降低重要未知因素以及可能影响参与者临床过程的已知因素中严重失衡的风险。随机化方法包括使用随机数表，计算机程序和抛硬币等。除了随机化以外，可以通过分配隐藏，盲目化和最小化后续损失来减少偏差。基础研究设计是并行并行类型，交叉类型和析因设计。其他类型包括大型试验，顺序试验，固定试验，解释性试验和实用试验。有效的推论取决于研究者设计，执行和报告各种程序的程度，以最大程度地减少试验中的偏差。进行RCT的步骤包括选择参考人群，选择实验或研究人群，获得知情同意，随机分配治疗和对照组，干预措施的应用，随访和最终评估结果。简介随机对照试验（RCT）是一种科学实验或临床试验形式，最常用于测试卫生保健服务或预防或治疗程序的安全性和有效性。 [1]在最近的几十年中，现代医学得到了药物武器库的大力支持，它比以前强大得多。如此迅速发展的一个主要因素是称为RCT的临床研究方法的发展和完善。临床试验被定义为涉及人类受试者的前瞻性科学实验，在受试者中启动了干预措施以评估治疗程序。[2]在RCT中，通过机会机制将每位患者分配到特定的治疗干预中。这些研究是目前所谓的“循证医学”的基础。没有将RCT在现代临床研究中的关键作用更清楚地表明这一特定研究方法放在循证医学证据级别列表的顶部。[3] RCT，也称为真实实验或干预研究被认为是证明干预与结果之间因果关系的金标准研究设计。与任何其他类型的临床研究信息相比，RCT的结果更具确定性。RCT可以根据所评估干预的不同方面进行分类。这些包括解释性或实用性试验，功效或有效性试验以及第1、2、3和4期试验。[4]在此，我们概述了RCT的基本原理。 RCT中的重要条款参加RCT的人（“研究人口”）称为“参与者”。参与者可以是患者，健康的志愿者，患者的亲属，公众，社区或机构。设计，进行研究并分析结果的人员称为“研究者”，例如，如果研究者说“ A”和他的同事正在进行一项研究，其中原发性高血压患者被随机接受一个β受体阻滞剂（或称“药物X”）和一种新上市的药物“ Y”（指血管紧张素受体阻滞剂（ARB）），“ A”及其同事将成为研究人员。参加者为原发性高血压患者;而干预措施是X药物和Y药物。RCT通常尝试衡量和比较

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