{"id":18125,"date":"2023-05-05T14:19:03","date_gmt":"2023-05-05T18:19:03","guid":{"rendered":"https:\/\/progclin.com\/?page_id=18125"},"modified":"2023-08-29T12:10:54","modified_gmt":"2023-08-29T16:10:54","slug":"about-clinical-trials","status":"publish","type":"page","link":"https:\/\/progclin.com\/about-clinical-trials\/","title":{"rendered":"About Clinical Trials"},"content":{"rendered":"\t\t
Clinical trials that are well designed and well executed are the best approach for eligible participants to:<\/p>
The risks to clinical trials:<\/p>
Informed consent is the process of learning the key facts about a clinical trial before deciding whether to participate. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether to participate, the doctors and nurses involved in the trial explain the details of the study. Then the research team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures and key contacts. Risks and potential benefits are explained in the informed consent document. The participant then decides whether to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.<\/p><\/div><\/div><\/div>
The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is federally regulated with built in safeguards to protect the participants. The trial follows a carefully controlled protocol, a study plan that 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\u2019 names remain secret, and are never mentioned in these reports.<\/p><\/div><\/div><\/div>
Side effects are any undesired actions or effects of a drug or treatment. Any known side effect is included in the informed consent form and reviewed before the study begins. Experimental treatments must be evaluated for both immediate and long-term side effects.<\/p><\/div><\/div><\/div><\/div><\/div><\/div><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t
People should know as much as possible about the clinical trial and feel comfortable asking the members of the health care team questions about it, including the care expected while in a trial or the cost associated with participating in the trial. The following questions might be helpful for the participant to discuss with the health care team. Some of the answers to these questions are found in the informed consent document.<\/p>
Every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits. An IRB is an independent committee of physicians, statisticians, community advocates and others that ensures that a clinical trial is ethical and the rights of study participants are protected. All institutions that conduct or support biomedical research involving people must, by federal regulation, have an IRB that initially approves and periodically reviews the research. Consider making the following preparations:<\/p>
Yes. Most clinical trials provide short-term treatments related to a designated illness or condition, but do not provide extended or complete primary health care. In addition, by having the health care provider work with the research team, the participant can ensure that other medications or treatments will not conflict with the protocol.<\/p><\/div><\/div><\/div>
Yes. A participant can leave a clinical trial at any time. When withdrawing from the trial, the participant should let the research team know about it, and the reasons for leaving the study.<\/p><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t
Ideas for clinical trials usually come from researchers. After researchers test new therapies or procedures in the laboratory and in animal studies, the treatments with the most promising laboratory results are moved into clinical trials. The trial of a new treatment builds a much clearer picture of its risks and its effectiveness.<\/p><\/div><\/div><\/div>