NIH – New Guidance for Clinical Trials

Clinical Trials Involving Human Subjects

The NIH is launching a series of policies to improve the accountability and transparency of clinical research. These upcoming changes will impact all applications involving clinical trials. Learn more about the new requirements, and determine if your study meets the NIH definition of a clinical trial.

Trials That Randomize Groups or Clusters or That Deliver Interventions to Groups

Experiments, including clinical trials, differ in the methods used to assign participants to study conditions or arms and to deliver interventions. The NIH has a new website that provides guidance on research methods related to experiments that randomize groups or clusters or that deliver interventions to groups. The information is relevant for human and animal studies and for basic and applied research. The website includes a calculator to estimate sample size requirements for group- or cluster-randomized trials.