Asking questions make a difference.
Why join a clinical trial?
By participating in a clinical trial, volunteers play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research.
What is our aim?
Novel Research’s primary concern is to inform our patients about the purpose of clinical trials. Listed below are the frequent questions and answers to explain what, how and who are able to participate in clinical research.
What is a clinical trial?
A clinical trial (also called a research study) is a study in which people volunteer to test new drugs. By conducting clinical trials, we learn whether new drugs (also called study drugs) are safe and effective for people to use. Old drugs may also be tested for new indications and treatments. These research studies are needed for developing new drugs for diseases and conditions like high blood pressure, diabetes, high cholesterol, etc. Once the new drug or study drug is found to be safe and effective, they may become available for doctors to prescribe.
Who can participate in a clinical trial?
All clinical trials have certain requirements which must be met in order to be eligible to participate in a research study. These requirements include factors such as age, gender, type of disease, current medication use and other medical conditions.
How does a clinical trial work?
Clinical trials are supervised by qualified doctors and researchers who work as a team with other doctors, nurses and health care professionals to conduct the research study. If someone is interested in participating in a clinical trial the volunteer will meet with someone from the study team who will explain and discuss the study. If after the discussion the volunteer wants to participate in the study, the study team member will give him/her an informed consent document to read and sign. The informed consent describes what the participant/volunteer can expect from participation in the study, such as the frequency of the study visits, what procedures will be done during the study, any potential benefits and possible risks or side effects of participating in the study. It is very important that the volunteer take his/her time to read the informed consent document carefully. If any questions regarding the document arise, the volunteer should discuss them with the study doctor and study coordinator. Once all the questions have been answered and the volunteer understands and is satisfied with the information, the site staff will ask the volunteer to sign the informed consent document. A signed copy is then given to the volunteer and the original is kept at the center. After signing the informed consent, information will be obtained from the volunteer to identify if he/she meets the requirements for study enrollment. Once eligibility is confirmed he/she will be enrolled in the study. Due to the various indications many studies have different requirements, but generally during the study the list below is what is expected to occur: The volunteer will be randomly assigned to a group of patients that are given the study drug or to a group that is given a placebo ( a placebo is an inactive product, like a sugar pill)