What is a Clinical Trial?
There are many definitions of clinical trials but generally they are health-related research studies in human beings that follow pre-defined protocol. Usually the research is done to determine the safety and effectiveness of a drug or treatment and to discover any side effects.
If someone volunteers to be part of a clinical study there are various kinds of studies to be part of. Drug studies may be a new medication and not tested on people before or it might be an existing medication being used in a new way. Sometimes a new medication or treatment is being compared to the best-known standard of care to see whether it is more effective or causes fewer side effects.
The information obtained during clinical trials helps regulatory authorities around the world determine if they will approve a drug or treatment to use in their country, The information can also guide health professions in the decisions about prescribing medications or other treatments for patients. It also helps determine the proper use of medications both prescribed and over-the-counter.
What is a Phase I Trial?
Phase I studies are the initial studies to determine the drugs basic safety, how it reacts in humans, the side effects associated with the increasing doses and to gain early evidence of effectiveness. Phase I studies may include healthy participants and/or patients.
Why would someone who is a healthy volunteer for a clinical trial?
A healthy volunteer could get a free comprehensive physical exam. Sometimes there is financial compensation. The personal satisfaction of helping is a reason many people participate.
Potential volunteers for Phase 1 studies will also be screened by age, height and weight, medical history, lifestyle habits and availability (some phase 1 studies require overnight stays).
Are there other Clinical Trial Phases?
Yes, there are more phases than just Phase I.
- Phase I – Screening for safety of drug or therapy in a small number of people.
- Phase II – Test the efficacy and safety of the drug or therapy in a larger number of people.
- Phase III – Confirm effectiveness, monitor side effects, compare to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely, on large groups of people usually 1000+ individuals are enrolled in Phase III studies.
- Phase IV – Study drugs or therapies after they are approved and gather more information on drug’s risks, benefits and optimum use.
What happens during a clinical trial?
The process during a clinical trial depends greatly on the kind of study being conducted. The study trial team includes, doctors, nurse practitioners, nurses, study coordinators, and other health care professionals. The study team will check the health of the potential volunteer at the beginning of the trial, give specific instructions for being part of the study, monitor the volunteer carefully for the duration of the trial and stay in touch once it has been completed.
Who funds clinical trials?
Clinical trials are funded, or sponsored by a variety of organizations, foundations, voluntary groups, and pharmaceutical companies, additionally clinical trials can also be sponsored by federal agencies such as the National Institutes of Health, the Department of Defense and the Department of Veteran’s Affairs. Trials can take place in many different settings, such as hospitals, universities, doctors’ offices, or community clinics.
What is a protocol?
A protocol is a study plan on which all clinical trials are based. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions. It describes what types of people may volunteer for the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study.
What is a placebo?
A placebo is an inactive, pill, liquid or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the experimental effectiveness.