+ 1. What is a clinical trial?
They are generally considered to be biomedical or health-related research studies in human beings that follow a pre-defined protocol. There are Interventional and Observational studies. Interventional studies are those in which the research subjects are assigned by the investigator to a treatment or other intervention, and their outcomes are measured. Observational studies are those in which individuals are observed and their outcomes are measured by the investigators.
+ 2. What is the reason for participation in clinical trials?
Participants can help others by contributing to medical research. Clinical trials can play a great role in the Participant's own health care and they can gain access to new research treatments before it is available on the market.
+ 3. What are the benefits of participating in clinical trials?
Clinical trials that are well-executed and well-designed for participants to:
+ 4. What are the risks of participating in a clinical trial?
There are risks to clinical trials.
+ 5. Who can participate in clinical trials?
Before joining a clinical trial, a participant must qualify for the study. All clinical trials have guidelines about who can participate. There are an inclucion and exclusion creteria that is an important principle of medical research. These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. The criteria are used to identify appropriate participants and keep them safe.
Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants.
+ 6. What is the prosess while on a clinical trail?
The clinical trial process depends on the kind of trial being conducted. The clinical trial team includes doctors and nurses as well as clinical trail professionals and other health care professionals. They check the health of the participant at the beginning of the trial, give 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, procedures and doctor visits than the participant would normally have for an illness or condition.
Clinical trial participation is most successful when the study protocol is carefully followed and there is frequent contact with the research staff.
+ 7. What are side effects and adverse reactions?
Side effects are any undesired reactions or effects of the experimental drug or treatment. Like any other medications, it is possible that the adverse effects or side effects may include headache, nausea, muscle cramps, skin rashes or other physical problems. Experimental treatments must be evaluated for both immediate and long-term side effects.
+ 8. What should I consider before participating in a trial?
People should know as much as possible about the clinical trial the want to participant in. You should feel comfortable asking the members of the health care team questions about the clinical trail, the care expected while in a trial, how many visits are required and the costs of the trial. Most of the answers to the participant's questions are found in the informed consent document.
+ 9. 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.
A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a clinical trial, participants following a protocol are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment.
+ 10. What is Informed Consent?
Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants.
The doctors and nurses involved in the trial explain the details of the study. If the participant's native language is not English, translation assistance 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, and contacts.
Risks and potential benefits are also explained in the informed consent document. The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.
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