subject: Overview of clinical trial [print this page] Overview of clinical trial Overview of clinical trial
OVERVIEW OF CLINICAL TRIAL
What is a clinical trial?
Clinical trials are usually considered to be biomedical or health-related research studies in human beings that follow a pre-specified protocol for study. Interventional studies are those in which the research subjects are assigned by the investigator to an action or other involvement, and their outcomes are measured. In observational studies individuals are observed and their outcomes are measured by the investigators.
Who can participate in a clinical trial?
All clinical trials have predefined strategy about who can participate. Using various inclusion/exclusion criteria is an important standard of medical research that helps to produce accurate and reliable results. The factors that allow someone to participate in a clinical trial are called "inclusion criteria" and which disallow someone from participating are called "exclusion criteria".
These criteria are based on various factors as age, race, and gender, the type and stage of a disease, details of previous treatment history, and other medical conditions. Before joining a clinical trial, a participant must meet the requirements for the study. Some research projects seek participants with illnesses or conditions to be observed in the clinical trial, while others need healthy participants. Inclusion and exclusion criteria are not used to reject people intentionally. Instead, the criteria are used to recognize appropriate participants and keep them safe and free from toxicity. These criteria help to make certain clues that researchers will be able to answer the questions they plan for research.
What happens during a clinical trial?
The clinical trial process depends on the kind of trial being conducted The clinical trial team includes doctors and nurses as well as various social workers and other health care professionals. They check the health of the contributor at the beginning of the trial, give pre defined specific instructions for participating in the trial, monitor the participant carefully during the trial, and stay in touch after the trial is completed.
Some clinical trials involve more tests and doctors visits than the participant would normally have for an illness or circumstances. For all phases of trials, the participant works with a research team. Clinical trial participation is most victorious when the protocol is carefully followed and there is regular contact with the research staff and participant.
What is informed consent?
Informed consent is the process of education knowledge about the key facts of clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide full information for participants. To help someone to decide whether or not to participate, the doctors and nurses involved in the trial explains the details of the study (both benefit and risk factors). If the participant's native language is not English, translation help can be provided. Then the research team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures, technical details and key contacts. Various risks and potential benefits are also explained in the informed consent document. The participant then solely decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any stage of trial.
What are the benefits and risks of participating in a clinical trial?
Benefits
Clinical trials that are well-designed and well-executed are the best approach for entitled participants to:
Play an active role in there own health care.
Expand access to new research treatments methodology before they are widely available.
Obtain specialist medical care at top health care facilities during the trial.
Risks
There may be unpleasant, serious or even life-threatening side effects towards experimental treatment.
The experimental treatment may not be successful for the participant.
The protocol may require more of their time and attention than would a non-protocol treatment, including trips to the study site, more treatments, hospital stays or even complex dosage requirements.
What are side effects and adverse reactions?
Side effects can be explained as any undesired actions or effects of the experimental drug or treatment method. Negative or adverse effects may include headache, nausea, hair loss, skin irritation, or other physical and mental problems. Experimental treatments must be evaluated for both instant and long-term side effects.
How is the safety of the participant protected?
The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is federally regulated by various regulatory laws with built in safeguards to protect the participants. The trial follows a carefully controlled protocol, a study plan which details what researchers will do in the study. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies. Individual participants' names will remain secret and will not be mentioned in these reports
What is a protocol?
A protocol is a predefined study plan on which all clinical trials are based. The plan is carefully planned to safeguard the safety of the participants as well as to answer specific research based questions. A protocol suggests the types of people can participate in the trial; the schedule of biological tests, procedures and parameters, medications, and dosages; and the duration of the study. While in a clinical trial, participants following a protocol are seen frequently by the research staff to monitor their health and to determine the safety and effectiveness of their treatment.
What are the phases of clinical trials?
Clinical trials are conducted in various phases. The trials at each phase have a different purpose and help scientists to answer different questions on research basis:
In Phase I trials, researchers test an investigational drug or treatment in a small group of people (20-80) for the first time to evaluate its safety and toxicity, determine a safe dosage range, and identify side effects.
In Phase II trials, the investigational study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase III trials, the investigational study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.
In Phase IV trials, post marketing studies performed with additional information including the drug's risks, benefits, and optimal use.
