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  • 17:00, 28 June 2025 Lawrence talk contribs created page Registry-based trials (Created page with "= Registry-Based Trials = '''Registry-based trials''' are randomized controlled trials (RCTs) that use data from existing patient registries to support key trial processes such as participant identification, randomization, data collection, and outcome assessment. By embedding trials within real-world data systems, they aim to increase efficiency, reduce costs, and improve generalizability. == When are they used? == Registry-based trials are conducted when a high-qualit...")
  • 16:41, 28 June 2025 Lawrence talk contribs created page Hybrid trials (Created page with "= Hybrid trials = '''Hybrid trials''' are studies that simultaneously evaluate both the clinical effectiveness of an intervention and the strategy used to implement it. These designs help accelerate the translation of research into practice by combining elements of effectiveness and implementation research within a single study. == When are they used? == Hybrid trials are used when there is: * Evidence suggesting the intervention may be effective, but further testing i...")
  • 16:39, 28 June 2025 Lawrence talk contribs created page Implementation trials (Created page with "= Implementation trials = '''Implementation trials''' are randomized studies that aim to evaluate the effectiveness of strategies designed to promote the adoption and integration of evidence-based interventions into routine clinical practice or community settings. These trials focus not on the clinical efficacy of the intervention itself, but rather on how best to implement it in real-world settings. == When are they used? == Implementation trials are used when an inte...")
  • 20:37, 4 April 2025 Lawrence talk contribs created page Trial Tree Wiki:About (Created page with "= About the TrialTree Wiki = The '''TrailTree Wiki''' is a collaborative knowledge base dedicated to supporting the design, conduct, reporting, and interpretation of randomized trials. It serves as a centralized hub for researchers, methodologists, students, and anyone interested in evidence-based trial design. == Purpose == The RCT Wiki aims to: * Provide clear, accessible guidance on all aspects of randomized trials * Foster best practices and transparency in trial...")
  • 02:11, 31 March 2025 Lawrence talk contribs created page Digital tools (Created page with "= Digital tools = == Overview == Digital tools are increasingly integrated into the design, conduct, analysis, and reporting of clinical trials. These tools enhance efficiency, improve data quality, facilitate participant engagement, and support real-time decision-making. As trials become more complex and geographically diverse, the use of digital technologies helps streamline operations and reduce burden on sites and participants. == Categories of Digital...")
  • 00:35, 31 March 2025 Lawrence talk contribs created page Estimands (Created page with "= Estimands = == Overview == An '''estimand''' is a precise description of the treatment effect to be estimated in a randomized controlled trial (RCT). It defines what is being measured, for whom, and under what conditions. The concept was formalized in the ICH E9 (R1) addendum to improve clarity and consistency in the interpretation of clinical trial results. == Motivation == Estimands help align trial objectives with study design, data collection, and analysis by cle...")
  • 21:02, 30 March 2025 Lawrence talk contribs deleted page My New Page (Test page)
  • 14:59, 30 March 2025 Lawrence talk contribs deleted page Sap document (content was: "SAP EXAMPLE. TESTING SUB PAGE", and the only contributor was "Lawrence" (talk))
  • 14:36, 30 March 2025 Lawrence talk contribs created page Frequentist and Bayesian approaches (Created page with "= Frequentist vs Bayesian approaches in trials = Statistical methods play a central role in the design, analysis, and interpretation of randomized controlled trials (RCTs). Two major frameworks—**Frequentist** and **Bayesian**—offer different approaches to understanding uncertainty and making inferences from data. While both are scientifically rigorous, they differ in how they define probability, handle prior information, and guide decision-making. Understanding the...")
  • 14:28, 30 March 2025 Lawrence talk contribs created page Internal and external validity (Created page with "= Internal and external validity = Validity in clinical trials refers to the degree to which the results of a study are true, credible, and applicable. Two essential types of validity are: * '''Internal validity''': Are the observed effects in the study due to the intervention and not other factors? * '''External validity (generalizability)''': Can the study findings be applied to people, settings, or times beyond those studied? Both are critical to the scientific c...")
  • 14:16, 30 March 2025 Lawrence talk contribs created page Quality of life measures (Created page with "= Quality of Life Measures in Clinical Trials = Quality of Life (QoL) measures evaluate the impact of a medical condition or treatment on a patient’s overall well-being, beyond traditional clinical endpoints such as survival or symptom control. These measures are essential in trials where patient-centered outcomes are critical, especially in chronic illness, cancer, mental health, and palliative care. == What is Quality of Life? == QoL refers to a multidimensional c...")
  • 14:05, 30 March 2025 Lawrence talk contribs created page Ethics (Created page with "= Ethics = Clinical trial ethics refers to the principles, guidelines, and oversight mechanisms that ensure research involving human participants is conducted with integrity, respect, and justice. Ethical conduct is critical for protecting participants, maintaining public trust, and producing credible scientific evidence. == Core Ethical Principles == The ethics of clinical research are grounded in widely accepted principles, particularly those from the Belmont Report...")
  • 22:38, 29 March 2025 Lawrence talk contribs created page Informed consent (Created page with "= Informed consent = Informed consent is a foundational ethical and legal requirement in clinical trials. It ensures that participants voluntarily agree to take part in a study after being fully informed of its purpose, procedures, risks, benefits, and alternatives. This process upholds individual autonomy and supports ethically sound research. == Purpose of Informed Consent == The goal of informed consent is to: * Protect the rights, safety, and well-being of partic...")
  • 22:23, 29 March 2025 Lawrence talk contribs created page Phases of trials (Created page with "= Phases of trials = Clinical trials are commonly conducted in phases, each with a distinct purpose, scope, and methodology. Understanding these phases helps clarify where a trial fits within the larger research pipeline, from early safety assessments to widespread implementation. == Phase 0: Exploratory (Microdosing) Trials == Also known as “first-in-human” studies. Phase 0 trials are optional early-phase studies involving very small doses of...")
  • 02:51, 28 March 2025 Lawrence talk contribs created page Multiple testing (Created page with "= Multiple testing = '''Multiple testing''', also known as '''multiplicity''', occurs in randomized controlled trials (RCTs) when multiple statistical comparisons are made. This increases the risk of a '''Type I error''' (false positives), potentially leading to incorrect conclusions about an intervention’s effectiveness or safety. == Why Is Multiple Testing a Concern? == Each statistical test carries a risk of a false positive. As the number of tests increases, so...")
  • 00:08, 28 March 2025 Lawrence talk contribs created page Methodological trials (Created page with "= Methodological Trials = '''Methodological trials''' are studies specifically designed to evaluate the effectiveness, validity, feasibility, or efficiency of research methods, trial designs, or statistical approaches used in clinical and health research. Their purpose is to improve the design, conduct, analysis, and reporting of randomized controlled trials (RCTs) and other research methodologies. == Purpose of Methodological Trials == Methodological trials address a...")
  • 23:50, 27 March 2025 Lawrence talk contribs created page Missing data (Created page with "= Missing data = Missing data in RCTs can compromise the integrity of trial results. It can introduce bias, reduce statistical power, and threaten the overall validity of the conclusions if not appropriately handled. == Impact of Missing Data == Missing data can bias results if its occurrence is related to treatment or outcomes, reduce the trial’s statistical power by decreasing the effective sample size, and undermine the validity of findings when not addressed with...")
  • 23:42, 27 March 2025 Lawrence talk contribs created page Data management plan (DMP) (Created page with "== Data Management Plan (DMP) == A Data Management Plan (DMP) outlines how data will be collected, stored, processed, analyzed, and shared throughout an RCT. A well-structured DMP ensures data integrity, security, compliance, and reproducibility. === 1. Key Components of a Data Management Plan (DMP) === ==== A. Study Overview ==== * '''Title''': Full name of the RCT. * '''Principal Investigator (PI)''': Name, institution, contact details. * '''Study Objectives''': Sum...")
  • 23:34, 27 March 2025 Lawrence talk contribs created page Database creation (Created page with "= Database Creation for Randomized Controlled Trials (RCTs) = A well-designed database is fundamental to the success of any RCT. It ensures reliable data collection, secure storage, efficient management, and regulatory compliance. Proper database planning also supports accurate analysis and valid trial conclusions. == 1. Key Considerations Before Database Creation == Before building the database, trial teams should assess the trial design, outcome variables, and timel...")
  • 23:29, 27 March 2025 Lawrence talk contribs created page Patient and public involvement (Created page with "= Patient and Public Involvement = Patient and Public Involvement (PPI) in RCTs refers to the active engagement of patients, caregivers, and members of the public throughout the research process—not just as participants, but as partners. Involving patients can improve study design, enhance relevance, and strengthen recruitment, retention, and dissemination of findings. == 1. Levels of Patient Involvement == PPI can occur at different levels of intensity and engageme...")
  • 23:22, 27 March 2025 Lawrence talk contribs created page Budgeting (Created page with "= Budgeting for Randomized Controlled Trials (RCTs) = Budgeting for a Randomized Controlled Trial (RCT) requires careful planning to ensure that all necessary resources are accounted for while optimizing efficiency. A well-prepared budget supports the trial’s feasibility, transparency, and funding competitiveness. == 1. Key Budget Categories == === A. Personnel Costs === Personnel often represent the largest portion of an RCT budget. Salaries should be calculated b...")
  • 23:13, 27 March 2025 Lawrence talk contribs created page Challenges and limitations (Created page with "= Challenges and Limitations of Randomized Controlled Trials (RCTs) = Randomized Controlled Trials (RCTs) are considered the gold standard for evaluating the efficacy and safety of interventions. However, despite their methodological strengths, RCTs come with several challenges that can affect their feasibility, ethical soundness, and real-world applicability. == Ethical and Practical Challenges == RCTs often raise ethical questions, especially when withholding a pote...")
  • 23:08, 27 March 2025 Lawrence talk contribs created page Clinical versus statistical significance (Created page with "= Clinical significance vs. statistical significance = In Randomized Controlled Trials (RCTs), interpreting results requires understanding both '''statistical significance''' and '''clinical significance'''. While they are related, they address different questions: one about the likelihood of an effect being real, and the other about whether that effect matters in practice. == 1. Statistical Significance == '''Definition:''' Statistical significance tests whether an o...")
  • 22:20, 27 March 2025 Lawrence talk contribs created page Sensitivity analysis (Created page with "= Sensitivity Analysis = '''Sensitivity analysis''' is a statistical technique used in RCTs to test the robustness of study findings by assessing how results change under different assumptions, data handling methods, or analytical strategies. It helps determine whether the trial’s conclusions remain valid when alternative scenarios are considered. == Objectives of Sensitivity Analysis == 1. '''Assess Robustness''': Test whether the main findings are stable under var...")
  • 22:12, 27 March 2025 Lawrence talk contribs created page Subgroup analysis (Created page with "= Subgroup analysis = '''Subgroup analysis''' in RCTs explores whether treatment effects differ across specific patient groups—such as by age, sex, or disease severity. While such analyses can provide insight into effect heterogeneity, they must be conducted and interpreted carefully to avoid false or misleading conclusions. == 1. When to Conduct Subgroup Analysis == * '''Pre-specified vs. Post-hoc''': Pre-specified subgroup analyses—planned before data collection...")
  • 22:03, 27 March 2025 Lawrence talk contribs created page Per-protocol analysis (Created page with "= Per-Protocol (PP) Analysis = '''Per-Protocol (PP) Analysis''' evaluates the effect of an intervention among participants who fully adhered to the assigned treatment protocol. In contrast to Intention-to-Treat (ITT) analysis, which includes all randomized participants regardless of adherence, PP analysis estimates the efficacy of an intervention under ideal conditions. == 1. When to Use Per-Protocol Analysis == PP analysis is particularly useful in specific scenarios...")
  • 21:58, 27 March 2025 Lawrence talk contribs created page Intention-to-treat analysis (Created page with "= Intention-to-Treat (ITT) Analysis = '''Intention-to-Treat (ITT) Analysis''' is a fundamental principle in the analysis of randomized controlled trials (RCTs). It ensures that all participants are analyzed in the group to which they were originally randomized, regardless of their adherence to the intervention, withdrawal, or deviations from the protocol. ITT is widely regarded as the gold standard approach for preserving the benefits of randomization and minimizing bia...")
  • 21:37, 27 March 2025 Lawrence talk contribs created page Analysis (Created page with "= Analysis of trials = When planning the analysis of a Randomized Controlled Trial (RCT), several key considerations must be taken into account to ensure the results are robust, valid, and reliable. Below are the main factors to consider: == 1. Defining the Research Question & Hypothesis == * Clearly state the primary objective and hypothesis (e.g., superiority, non-inferiority, or equivalence). * Specify secondary outcomes and exploratory analyses. == 2. Study Design...")
  • 21:27, 27 March 2025 Lawrence talk contribs created page Qualitative data (Created page with "= Incorporating Qualitative Data in Randomized Controlled Trials (RCTs) = Integrating '''qualitative data''' into Randomized Controlled Trials (RCTs) enhances understanding of how and why interventions work—or fail to work—by examining participant experiences, implementation challenges, and contextual influences. This mixed-methods approach complements quantitative findings and strengthens trial design, interpretation, and applicability in real-world settings. == 1...")
  • 21:21, 27 March 2025 Lawrence talk contribs created page Expertise-based trials (Created page with "= Expertise-Based Randomized Controlled Trials (EBRCTs) = An '''expertise-based randomized controlled trial (EBRCT)''' is a trial design where participants are randomized to treatment groups based on the expertise of the clinician delivering the intervention. Unlike traditional RCTs—where the same clinicians may deliver multiple treatments—EBRCTs assign participants to clinicians who specialize in only one of the interventions. This approach is particularly useful i...")
  • 17:59, 27 March 2025 Lawrence talk contribs created page Sample size (Created page with "= Sample size = Determining an appropriate sample size is a critical step in designing a randomized controlled trial (RCT). A well-calculated sample size ensures that the study has sufficient statistical power to detect a clinically meaningful effect, while also considering ethical, financial, and logistical constraints. This page outlines the main factors influencing sample size decisions in RCTs. == Statistical Considerations == Sample size determination starts with...")
  • 16:40, 27 March 2025 Lawrence talk contribs created page Run-in periods (Created page with "= Run-in periods = A '''run-in period''' is a phase that occurs before randomization in a randomized controlled trial (RCT), during which all participants receive a specified intervention—this could be an active treatment, a placebo, or no intervention at all. This pre-randomization period is used strategically to improve the quality and efficiency of the trial. By observing participants during the run-in, researchers can exclude those who are unlikely to comply with...")
  • 16:07, 27 March 2025 Lawrence talk contribs deleted page Systematic Review (content was: "#REDIRECT Systematic review", and the only contributor was "Lawrence" (talk))
  • 16:06, 27 March 2025 Lawrence talk contribs created page Systematic review (Created page with "= Systematic review = Conducting a '''systematic review''' before launching a randomized controlled trial (RCT) is a critical step to ensure that the new study is scientifically necessary, methodologically sound, and ethically appropriate. Systematic reviews synthesize all available high-quality evidence on a particular topic, helping researchers identify what is already known and what gaps remain. == 1. Identifies Knowledge Gaps == A systematic review enables researc...")
  • 16:06, 27 March 2025 Lawrence talk contribs moved page Research Question to Research question without leaving a redirect (Misspelled title)
  • 16:00, 27 March 2025 Lawrence talk contribs deleted page Systematic review (Author request: content was: "#REDIRECT Systematic review", and the only contributor was "Lawrence" (talk))
  • 15:58, 27 March 2025 Lawrence talk contribs moved page Systematic Review to Systematic review (Misspelled title)
  • 15:58, 27 March 2025 Lawrence talk contribs deleted page Systematic review (content was: "== Importance of Conducting a Systematic Review Before a Randomized Controlled Trial (RCT) == Conducting a systematic review before an RCT is essential for ensuring the trial is scientifically justified, methodologically sound, and ethically responsible. === 1. Identifies Knowledge Gaps === * A systematic review summarizes existing evidence, helping researchers determine...", and the only contributor was "Lawrence" (talk))
  • 15:57, 27 March 2025 Lawrence talk contribs moved page Systematic Review to Systematic review (Misspelled title)
  • 15:55, 27 March 2025 Lawrence talk contribs created page Patient-reported outcomes (Created page with "= Patient-reported outcomes = '''Patient-reported outcomes (PROs)''' are measurements of a patient’s health status, quality of life, or symptoms directly reported by the patient, without interpretation by clinicians or researchers. In randomized controlled trials (RCTs), PROs play a vital role in capturing the impact of interventions from the patient’s perspective, complementing clinical or laboratory outcomes. == Importance of PROs in RCTs == PROs provide unique...")
  • 15:19, 27 March 2025 Lawrence talk contribs created page Trial outcomes (Created page with "= Trial outcomes = Selecting and measuring appropriate outcomes is a critical aspect of designing a randomized controlled trial (RCT). Outcomes provide the data needed to evaluate whether an intervention works, how it works, and what its risks may be. Carefully chosen outcomes enhance the trial’s scientific validity, ethical justification, and relevance to clinical practice. == Defining Primary and Secondary Outcomes == The '''primary outcome''' is the main result t...")
  • 15:03, 27 March 2025 Lawrence talk contribs created page Trial controls (Created page with "= Trial controls = In randomized controlled trials (RCTs), the control group plays a vital role in determining the true effect of an intervention. By providing a point of comparison, control groups help isolate treatment effects from placebo responses, natural progression, or other confounding factors. The selection of an appropriate control depends on ethical considerations, trial objectives, and practical feasibility. Below are the most commonly used types of control...")
  • 14:55, 27 March 2025 Lawrence talk contribs moved page TiDieR to TIDieR without leaving a redirect (Misspelled title)
  • 14:51, 27 March 2025 Lawrence talk contribs created page TiDieR (Created page with "= TIDier = The '''Template for Intervention Description and Replication (TIDieR)''' checklist is a structured reporting tool developed to improve the transparency, reproducibility, and usability of health interventions. As an extension of the CONSORT and SPIRIT guidelines, TIDieR provides a systematic framework for detailing the components of an intervention, enabling researchers, clinicians, and policymakers to understand, replicate, and apply interventions in...")
  • 14:35, 27 March 2025 Lawrence talk contribs created page Trial interventions (Created page with "= Trial interventions = Designing the intervention for a randomized controlled trial (RCT) is a critical step that requires careful consideration to ensure the intervention is feasible, consistent, replicable, and effective. Whether the intervention involves a drug, device, behavioral strategy, or complex care model, its definition and delivery can substantially impact the trial's internal validity and applicability. == Defining the Intervention == The intervention mu...")
  • 14:06, 27 March 2025 Lawrence talk contribs created page First-in-man trials (Created page with "= First-in-man trials = A '''First-in-Man (FIM) trial'''—also known as a '''First-in-Human (FIH) trial'''—is the first clinical study in which a new investigational drug, biologic, or medical device is administered to human participants. These trials follow extensive preclinical testing and are typically classified as Phase 1 trials. The primary focus of FIM trials is to assess safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) before proceeding...")
  • 14:03, 27 March 2025 Lawrence talk contribs created page Vanguard trials (Created page with "= Vanguard Trials = A '''vanguard trial'''—also referred to as a pilot trial embedded within a larger trial, i.e., '''internal pilot'''—is a type of feasibility study conducted as the initial phase of a definitive randomized controlled trial (RCT). Its purpose is to test the feasibility of the main trial’s methods before fully launching it. Unlike standalone pilot trials, the data collected in a vanguard trial can be incorporated into the main trial if predefined...")
  • 19:46, 26 March 2025 Lawrence talk contribs created page Group sequential trials (Created page with "= Group sequential trials = A '''Group Sequential Trial''' is an adaptive randomized controlled trial (RCT) design that incorporates pre-planned interim analyses at defined time points before the trial concludes. This approach enables researchers to stop the trial early for efficacy, futility, or safety concerns. By doing so, group sequential designs can conserve resources, minimize participant exposure to ineffective treatments, and accelerate regulatory decision-makin...")
  • 19:33, 26 March 2025 Lawrence talk contribs created page Regulated trials (Created page with "= Regulated trials = A '''regulated trial''' is a clinical trial that is subject to the oversight of national or international regulatory authorities. These include agencies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), Health Canada, and others. Regulated trials typically involve investigational drugs, biologics, medical devices, or advanced therapy medicinal products (ATMPs), and must comply with rigorous standards to ensure...")
  • 19:29, 26 March 2025 Lawrence talk contribs created page Non-inferiority trials (Created page with "= Non-Inferiority Trials = A '''non-inferiority trial''' is designed to determine whether a new intervention is not unacceptably worse than an existing standard treatment, based on a predefined threshold known as the non-inferiority margin. These trials are especially important when the new treatment may be slightly less effective but offers other clinical or logistical advantages—such as fewer side effects, lower cost, or easier administration. == Defining the Non-I...")
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