Clinical research with human subjects – is a type of scientific research that involves studying the effects of medical treatments, interventions, or devices on human participants.
Definitions
NIH Director's Panel on Clinical Research
- Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. This area of research includes:
- Mechanisms of human disease
- Therapeutic interventions
- Clinical trials
- Development of new technologies
- Epidemiologic and behavioral studies
- Outcomes research and health services research
Excluded from this definition are in vitro studies that utilize human tissues but do not deal directly with patients [1].
Goal of clinical research
The primary goal of clinical research is to gather data and evidence about the safety and effectiveness of new drugs, medical devices, procedures, or healthcare interventions.
Clinical research is conducted to answer specific research questions, often related to the prevention, diagnosis, treatment, or management of medical conditions.
Overview of clinical research conduct
Regulatory approval
Before clinical trials can begin, researchers often need approval from regulatory agencies such as the U.S. Food and Drug Administration (FDA) in the United States. These agencies review study protocols and safety data.
Ethical considerations
Clinical research involving human subjects is conducted under strict ethical guidelines and regulations to ensure the safety and well-being of participants. These guidelines are typically established by ethical review boards and government agencies.
Informed consent
Participants in clinical research must provide informed consent, which means they are fully informed about the study's purpose, procedures, potential risks, and benefits. They have the right to withdraw from the study at any time.
Safety monitoring
Safety is a paramount concern in clinical research. There are mechanisms in place to monitor and report adverse events or side effects promptly. Studies can be stopped if safety concerns arise.
Data collection
Researchers collect data on participants' health and outcomes during the study, often through various measurements, tests, and observations. The data is analyzed to draw conclusions about the intervention's effectiveness.
Phases
Clinical trials are typically conducted in several phases, starting with early-phase trials to evaluate safety and efficacy in a small group of participants, and progressing to larger Phase II and Phase III trials to gather more data on safety and effectiveness. Phase IV trials may follow after a treatment is approved, to monitor long-term outcomes and side effects.
See also
Another relevant pages
Links to this page
- Codex of clinical research (← links)
- Sandbox (← links)
- Phase I clinical trials (← links)
- Clinical study (← links)
- Independent data-monitoring committee (← links)
- Protocol (← links)
- Basic experimental studies involving humans (← links)
- Clinical research regulations in the European Union (← links)
References
- ↑ NIH, 1997, Executive Summary--NIH Director's Panel on Clinical Research Report 12/97, https://grants.nih.gov/grants/NIH_Directors_Panel_Clinical_Research_Report_199712.pdf Accessed May 2024
External links
- NIH, 1996, ADVISORY COMMITTEE TO THE DIRECTOR December 12, 1996 Meeting Minutes, https://acd.od.nih.gov/documents/minutes/12121996minutes.html Accessed May 2024
- CFR, 2018, 45 CFR 46.104 Exempt research, https://www.ecfr.gov/on/2018-07-19/title-45/section-46.104 Accessed May 2024