Clinical trials are volunteer-based studies that give researchers insights into diseases, so they can develop effective treatments and medications.
This roundtable will be videocast on March 11, 2020. See draft agenda See participant list DRAFT Backgrounder Current State: Most clinical trials funded by NIAMS use traditional randomized clinical trial (RCT) designs, which measure the difference in average outcome between participants assigned to one intervention or another. However, it would be more clinically useful to understand who, within the relevant population, would likely benefit more from (or be harmed by) either intervention. This can be addressed to some extent in an RCT by stratification, but at a significant increase in costs and requiring pre-specification. Other strategies may also provide practical
The NIAMS clinical trials program is designed to support a range of studies from small first-in-human, tolerability or exploratory studies, to larger trials of efficacy or effectiveness. These FAQs apply to investigator-initiated clinical research grants only.
Anyone, an individual or an organization, can donate to the NIAMS. The NIAMS is federally funded and not a fundraising organization; but, the U.S. Congress authorizes NIAMS to accept donations and bequests to support the scientific mission of the Institute. Donations to NIAMS are deposited in a NIAMS “Gift Fund”
The clinical study Principal Investigator (PI) safety monitoring responsibilities with respect to a Data and Safety Monitoring Board (DSMB) or Observational Study Monitoring Board (OSMB) ensure the study is conducted according to the highest scientific and ethical standards. Responsibilities are outlined in bold italics.
The NIH defines a clinical trial as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. Clinical trials range from small
This document outlines the process by which requests for access to existing biospecimens from the OAI resource are processed, evaluated, and approved. Types of Specimen Available Type of Specimen Maximum Allowable Specimen Per Study Serum 0.15 ml (total of serum and plasma per study) EDTA plasma 0.15 ml (total of
Learn about the NIH and NIAMs requirements for data and safety monitoring, guidelines for creating a DSM plan, and types of DSM document review. The DSM may consist of a Data and Safety Monitoring Board (DSMB) or a Safety Officer (SO). The DSM bodies are advisory to the Institute Director
The AMP RA/SLE Program brings together the NIH and medical community to address rheumatoid arthritis and lupus with diagnostic and drug advancements.
PROMIS® developed pediatric measures for the functions, symptoms, behaviors, and feelings shown here. Self-report measures are used for children ages 5-17. Parent proxy-report measures are used for children ages 5-17. Measures are applicable to the general population and to those with chronic conditions.
December 2017 Word Version (DOC – 75 KB) PREFACE Investigators should consider using this template when developing the Data and Safety Monitoring Plan (DSMP) for clinical studies supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). The goal of the DSMP is to provide a general
This document PDF format (747 KB) Prepared by the National Institute of Arthritis and Musculoskeletal and Skin Diseases December 22, 2015 Contents Introduction Chapter 1: Etiology and Prevention Genetics and Genomics Environment Epidemiology Chapter 2: Mechanisms of Disease Immune and Inflammatory Mechanisms Target Organ Damage Chapter 3: New Treatments and