What is a clinical trial?
Clinical trials are scientific and medical studies done on human volunteers to test the safety and effectiveness of new drugs and medical treatments.
Why conduct clinical trials?
Clinical trials are an invaluable part of developing and discovering new drugs and their safety for use in humans. Without clinical trials we would not have the opportunity to investigate better treatments for those who need them.
What is a protocol in clinical trials?
A clinical trial protocol is a set of guidelines for how the trial will be conducted, monitored and reported on. Everyone participating in a clinical trial is expected to follow the protocol so that results can be consistent.
What are clinical trial phases?
Clinical trial phases are various phases of research that new drugs go through before being approved for use by the general public. Phase I – IV are the phases that drugs go through with the number of participants generally increasing with each phase.
Who can participate in clinical trials?
Each clinical trial has a set of criteria that needs to be met before someone can be approved for participation. If a volunteer meets those criteria they may be chosen to participate. Healthy people can also participate in clinical trials.
What are some of the ethical issues related to clinical trials?
Organizations that conduct clinical trials are held accountable to several outside agencies to ensure they are acting ethically. Many also govern themselves by ethical principles. These include no harm to the patients, showing respect for each participant through informed consent and objectively weighing the risk/benefit ratio.
What are the rights of participants in clinical trials?
All participants in clinical trials have the right to informed consent and they can withdraw from the trial at any time. Informed consent is not a contract that they are obliged to fulfill.
How is the privacy of participants protected in clinical trials?
When someone agrees to participate in a clinical trial they are usually asked to tell their regular doctor. Beyond that though, their participation is strictly confidential. During and after the clinical trials the people running the trial are not allowed to reveal anything that would allow clinical investigators to identify participants.
Who pays for clinical trials?
Sponsors cover the costs of clinical trials. Sponsors are often a government agency, a private organization or a pharmaceutical company.
Will I get paid to participate in a clinical trial?
Clinical trials participants don’t pay for the treatments they receive and they may receive compensation for their time, travel and inconvenience. Compensation should be clearly outlined prior to the trial beginning.
What are the benefits of participating in clinical trials?
Participation in clinical trials can be a rewarding experience. It gives those with an illness access to experts and new treatments. Volunteers and clinical trials help advance medical research and treatments.
Are there risks to participating in a clinical trial?
Every measure is taken to ensure the safety of participants during clinical trials. There can be some risks involved though. Potential risks should be discussed with participants and disclosed in the informed consent document.
What type of information is published about clinical trials?
The results of clinical trials may be published in medical journals. The information published usually includes the results of the trial regarding the drug or treatment being tested.
What happens to participants when a clinical trial ends?
In many cases when a clinical trials ends the participants go back to their former health care provider. In some cases though when a new drug has proven successful they will be able to continue the medication. The records from clinical trials are required to be kept, but participant’s confidentiality remains strictly protected.