Clinical Trial Frequently Asked Questions
People with the condition being studied or healthy people can volunteer to take part in a clinical trial. Each study has specific entry requirements such as age or a medical condition necessary for participation. The doctor in charge of the study must review the volunteers’ medical history to determine if he/she is eligible to participate based on strict study conditions called entry criteria. For full list of inclusion and exclusion criteria for this trial, please visit https://bit.ly/OASIStrial
A medical doctor is usually responsible for carrying out the study according to the study protocol. Before a clinical trial can begin to enroll volunteers an Institutional Review Board (IRB) must approve it. The IRB is a committee made of healthcare experts that review each study to protect patient rights and ensure the safety of research volunteers. The IRB also ensures the research is scientifically sound and is involved in the review of safety issues throughout the study.
One of the documents the RB must review and approve is called an Informed Consent Form. This form is provided to volunteers who are interested in participating in a clinical trial program. The informed consent includes everything a volunteer needs to know about the study such as risk and potential benefits, so that he/she can make an informed decision as to whether or not to participate. The process allows volunteers to ask questions. Volunteers are encouraged to take their time in making a decision before signing the consent and joining the study. You and your family should feel completely comfortable with your decision to participate before you sign the consent.
After a clinical trial is completed, the researchers carefully examine information collected during the study before making decisions about the meaning of the findings and about the need for further testing. After a phase I or I| trial, the researchers decide whether to move on to the next phase or to stop testing the treatment or procedure because it was unsafe or not effective. When a phase Ill trial is completed, the researchers examine the information and decide whether the results have medical importance. Results from clinical trials are often published in peer-reviewed scientific journals. Peer review is a process by which experts review the report before it is published to ensure that the analysis and conclusions are sound. If the results are particularly important, they may be featured in the news, and discussed at scientific meetings and by patient advocacy groups before or after they are published in a scientific journal. Once a new approach has been proven safe and effective in a clinical trial, it may become a new standard of medical practice. Ask the research team members if the study results have been or will be published. Published study results are also available by searching for the study’s official name or Protocol ID number in the National Library of Medicine’s PubMed® database.
There are federal rules in place to help protect the rights and safety of people who take part in clinical trials. Learn about informed consent, institutional review boards (IRB’s), and how trials are closely monitored.
If you are thinking about taking part in a clinical trial, be sure to ask your doctor, “Is there clinical trial that I can join?” If your doctor offers you a trial, here are some questions you may want to ask. Questions provided by NCl. (https://www.cancer.gov/about-cancer/treatment/clinical-trials/questions)
More information on this clinical trial can be found on clinicaltrials.gov. ClinicalTrials.gov Identifier: NCT04720664