Our main purpose in defining the clinical trials is to improve dissemination & transparency. The bottom line is if public is going to be spent to conduct experiments on people, you are expected to report the results.
Clinical trials are clinical research studies. Clinical research includes all the research involving the human participants in general. It does not include secondary studies using existing biological specimens or data collected without identifiers or data that are publicly available.
Clinical trials are clinical research studies involving human participants assigned to an intervention in which the study is designed to evaluate the effect(s) of the intervention on the participant and the effect being evaluated is a health-related biomedical or behavioral outcome.
How do we determine whether a particular trial is a Clinical Trial?
The following questions needs to be asked to evaluate whether the particular trial is a clinical trial.
- Does the study involve human participants?
- Are the participants prospectively assigned to an intervention?
- Is the study designed to evaluate the effect of intervention on the participants?
- Is the effect being evaluated as a health related bio medical of behavioral outcome?
So if all these questions answers a Yes it’s a clinical trial for sure, and if no then its not.
Fast facts on Clinical Trials
- Clinical trials aim to find out whether a medical strategy, treatment, or device is safe and effective for humans to use or consume.
- Trials consist of four phases, and they can focus on: treatment, prevention, diagnostic, screening, supportive care, health services research, and basic science.
- A research team will likely include doctors, nurses, social workers, health care professionals, scientists, data managers, and clinical trial coordinators.
- Participation can involve both risks and benefits. Participants must read and sign the “informed consent” document before joining a trial.
- Risks are controlled and monitored, but the nature of medical research studies means that some risks are unavoidable.
Finally the outcome of a Clinical Trial determines if a new Medical Strategy, treatment or a device
- Has positive effects on a patients prognosis
- Causes unforeseen harms
- Has no positive benefits or has a negative effect
Clinical trials can provide valuable information regarding the cost-effectiveness of a treatment, the clinical value of a diagnostic test, and how a treatment improves quality of life.