Find Funding NIH Guide for Grants and Contracts, A. 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” (NOT-OD-15-015). Will the definition of clinical trial create inequities in peer review? Clinical research includes all research involving human participants. An intervention is defined as a manipulation of the subject or subject’s environment for the purpose of modifying one or more health-related biomedical or behavioral processes and/or endpoints. National Institutes of Health (NIH), 9000 Rockville Pike, Bethesda, Maryland 20892. Trial results showed that patients receiving dexamethasone demonstrated a lower mortality rate compared with patients receiving usual care. Studies eliciting opinions or preferences in the absence of an intervention are not considered to be clinical trials. If the study is not designed to assess whether a prospectively assigned intervention modifies a behavioral outcome, the study is not a clinical trial. It depends. Does the study involve human participants? The difference between NIH’s Definition of a Clinical Trial (CT) and what FDA will consider a CT under the requirements of its Investigational New Drug (IND) or Device Exemption (IDE) Process affects a small number of NIH applications proposing certain types of research. The following questions should be used to determine whether a study meets the NIH clinical trial definition: If the answers are all “yes,” the study is a clinical trial. Revised Common Rule §__.102(b): “Clinical trial means 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 the interventions on biomedical or behavioral health-related outcomes.”, https://www.gpo.gov/fdsys/pkg/FR-2017-01-19/pdf/2017-01058.pdf, NIH clinical trial definition: “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.” (Oct 23, 2014), https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html. No; a transient health-related outcome is sufficient for a study to be considered a clinical trial, as long as all other elements of the NIH clinical trial definition are met. The NIH Definition of “Clinical Trial” 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. Is the study designed to evaluate the effect of the intervention on the participants? Yes; in these studies, both the healthcare providers and patients are human participants, and the healthcare providers become part of the intervention. (https://humansubjects.nih.gov/glossary). 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. No; a study must be designed to evaluate the effect of the intervention on the human participant to meet the NIH clinical trial definition. A key element of these stewardship reforms was the development of a clearer, more comprehensive definition of clinical trial. The NIH definition may be broader than other clinical trial definitions because it reflects NIH’s mission and considers all biomedical or behavioral outcomes to be health-related. NIH has a specific definition of what’s considered a clinical trial: 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. Yes; the NIH clinical trial definition specifies that there must be one or more human participants involved in the study. Are studies that propose to evaluate a clinical intervention or to develop a diagnostic tool considered to be clinical trials? We are dealing with a serious problem. For example, a study that evaluates if enrollment in a summer internship program alters the student’s opinions on their educational pathway would not be assessing a health-related biomedical or behavioral outcome. The benefits of transparency and the need to fulfill the ethical obligation to participants is as relevant to these types of trials as to any other type.”. Are measurements the same as interventions? In a continuing effort to help researchers determine whether their proposed study is a clinical trial (CT), NIH has recently enhanced two resources: NIH Definition of Clinical Trial Case Studies and Frequently Asked Questions—NIH Clinical Trial Definition. Our purpose in defining clinical trials as we do is to improve dissemination and transparency. (See Case Study https://grants.nih.gov/policy/clinical-trials/case-studies.htm#case7b). NIH will continue to update case studies, FAQs, tools, and resources to clarify guidance around the NIH clinical trial definition. Phase I device studies may or may not meet the NIH definition of a clinical trial. It depends; studies that involve prospective assignment of human participants to an intervention, which may be a clinical intervention or development of a diagnostic tool, and that are designed to evaluate an effect of the intervention on the participant, where the effect is a biomedical or behavioral health outcome, are clinical trials. In our policy notice on the Dissemination of NIH Funded Clinical Trial Information we stated, “We disagree with commenters who suggested that there is no need for coverage of certain types of trials, such as early exploratory trials, small trials, trials assessing only safety, or trials that terminate before reaching enrollment targets. In this example, the study is designed to compare the functionality of devices, and not the effect of the devices on the participant. (https://humansubjects.nih.gov/glossary) Clinical trials are research studies that involve people and test new ways to prevent, detect, diagnose, or treat diseases. Clinical studies that that are not defined as clinical trials by the NIH definition of clinical trial. Key case in point: using an intervention that does not have a direct therapeutic or clinical outcome, i.e., is not used to achieve a clinical goal or determine a subject’s course of treatment, could now be classified as a CT. This is an unacceptable state of affairs. Español, Get the latest public health information from CDCGet the latest research information from NIHNIH staff guidance on coronavirus (NIH Only). Are studies that are not designed to impact diagnoses or treatment of patients considered to be clinical trials? However, studies that gather opinions from participants after an experimental manipulation or intervention, may be clinical trials. Clinical trials look at new ways to prevent, detect, or treat disease. Are studies designed to compare the diagnostic performance of two approved diagnostic devices considered to be clinical trials? Additionally, NIH staff are prepared to help researchers determine whether their studies meet the NIH clinical trial definition. NIH Definition of a Clinical Trial. Phase I device studies are not classified as applicable clinical trials (ACTs). In a continuing effort to help researchers determine whether their proposed study is a clinical trial (CT), NIH has recently enhanced two resources: NIH Definition of Clinical Trial Case Studies and Frequently Asked Questions—NIH Clinical Trial Definition. They are the primary way that researchers find out if a new treatment, like a new drug or diet or medical device (for example, a pacemaker) is safe and effective in people. 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