Frequently asked questions about clinical trials
Here are some answers to frequently asked questions about clinical trials at Duke.
Who sponsors clinical research?
Clinical trials may be funded by the federal government (through the National Institutes of Health or other organizations), physicians, medical centers, foundations, or pharmaceutical companies.
Trials normally take place at Duke University Medical Center. Patients usually receive free or subsidized care for the duration of the trial, but sometimes participants are required to pay for treatment or tests. Insurance may or may not cover care received during a clinical trial.
What are the risks of participation?
It is important to realize that there are some risks to participating in a clinical trial. They may include:
- Unpleasant or even serious side effects
- Ineffective, experimental treatment
- Inconvenience resulting from trips to the study site, hospital stays, complex dosage requirements, etc.
How is my safety protected?
Trial practitioners must abide by the same ethical and legal codes they follow during routine care. Certain federal regulations also apply specifically to clinical research.
The process starts with a study protocol, which is a plan that must meet certain safety standards to be approved by Duke’s Institutional Review Board (IRB). Our IRB often requires researchers to report back periodically throughout the course of the trial to ensure patient safety.
The IRB also carefully reviews the consent form for the study to ensure that it meets all the criteria of the federal regulations that govern clinical trials.
When researchers publish the results of the trial, individuals’ names are kept secret to maintain patient privacy.
What is informed consent?
Informed consent is the process of learning key information about a clinical trial before deciding whether to participate. The informed consent process involves talking to a doctor, nurse, or other researcher about the trial and reviewing the consent form document with him or her.
During the consent process, you will learn about the study’s purpose, the activities you will undergo, how long you will be in the study, any potential benefits or risks (bad effects) you may experience as a result of the study, and other aspects of the study.
In addition, you will be encouraged to ask any questions you may have about the study. If you decide to participate after going through the consent process, then you will be asked to sign the consent form.
Can a participant leave a trial once it has begun?
As a research participant, you have the right to withdraw from a study at any time. You can withdraw, or decide not to participate at all, without affecting your access to health care at Duke.
What happens when a clinical trial is over?
After a clinical trial has come to a conclusion, researchers analyze the results to determine what they mean. After a phase I or II trial, they need to decide whether to advance to the next phase or discontinue testing.
After a study has completed phase III, researchers assess the medical importance of the data and publish the results in a scientific journal. If the results show that the new treatment or drug is safe and effective, it may become standard practice in medical centers across the country.
Where can I learn more about what to consider before volunteering to be in a clinical trial?
Who can I call to discuss problems, concerns, and questions or to obtain information or offer input?
The Institutional Review Board Office at 919-668-5111 can be contacted to discuss problems, concerns and questions or to obtain information or offer input.