Before entering into any clinical trial, there are certain things you need to be aware of. The National Library of Medicine suggests several questions you should ask and fully understand before entering into any clinical trial.
1. What do researchers hope to learn from this study?
Clinical trials are developed for different reasons. Some study the effectiveness of certain meds while others study which doses are safe. Know the purpose of the study prior to signing on.
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2. Has the item or intervention been studied before?
Most medical interventions or drugs must be studied in a controlled setting many times before being approved for use in the general population. Make sure you know if the intervention has been studied before and if it is in use currently.
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3. What is being studied?Clinical trials are conducted on many different aspects of medical care. Medicines, diagnostic techniques, and treatments all need clinical trials before being approved for widespread use. Know what is being studied in your trial.
4. Who will be in charge of my care during the trial?Most often your doctor will continue to manage your care during a clinical trial. However, many times different practitioners will join your health care team or participate in your care during the trial. Know your healthcare team prior to any clinical trial.
5. Will my care change during the trial?Make sure you understand how your routine care will change during the clinical trial. Will you have more frequent visits? Will blood be drawn? Will there be hospital stays? While your overall care most likely will not change, many times things will be added to your care routine. Make sure you know what they are.
6. Are there any expected side effects? What are the risks and benefits?Many medicines are treatment regimens have some side effects you should know about. Be aware of what to look for and what to do if you experience them. Also know if there are any benefits to being involved with the study or if there are any risks as a result of the trial.
7. How long will the trial last?Sometimes trials involve one day or one blood draw. Often, especially in drug trials, the trial will last for several months or even years. Know the expected duration of your trial before signing on.
8. Who pays for the study? Will I be paid?Many times the study will include payment to your for your trouble and your time. In addition, trials often pay for doctors visits, medications, blood work or diagnostics that are part of the study. Know exactly who pays what and if you are getting paid.
9. Can I be forced or asked to leave the study?While investigators do everything in their power to make certain you complete the study, at times you may be asked to leave the study. If their is a change in your health status that makes it dangerous for you to participate or if you are unable to follow the prescribed protocol you may be asked to discontinue the study. Ask about conditions that would necessitate your leaving the study prior to its completion.
10. Can I learn the results of the study?When the clinical trial is completed, the data is analyzed and conclusions are made. Ask the investigator how you can learn the results of the study once it is completed.