Clinical Trials

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)

More on the process

Medical history of the volunteer will be reviewed and documented. The Principal or Sub-Investigator will perform a physical exam Blood samples will be collected as well as a urine sample for study specific tests. EKG, vital signs, height and weight will be captured A discussion on the required study visits will be completed During the length of the research study the health of the volunteer will be checked and monitored.

What Questions Should The Volunteer/Participant Ask The Research Team?

It is important that the volunteer knows as much as possible about the clinical trial so that he/she can make an informed decision as to whether or not he/she wants to participate in the study. Here are some questions that may be asked to the study doctor:

  • What is the purpose of this research study?

    Before agreeing to participate in a research study the volunteer should be sure he/she understands the purpose of the research study.

  • How long is the study?

    Before enrolling in a research study the volunteer should know the expected duration of the study, how many visits and how frequent the study visits will be.

  • What kinds of tests and procedures are involved in the study?

    Before agreeing to participate in a research study the volunteer should know what types of tests and procedures will be done.

  • Is there a chance of receiving a placebo?

    Before enrolling in a research study the volunteer should know if the study includes the possibility of receiving a placebo. He/she should also be sure that they understand what a placebo is.

  • Can participation in the study be stopped at any time?

    As a research volunteer he/she can withdraw at any time. If the volunteer decides to withdraw from the study he/she should inform the study coordinator or study doctor of their choice. The volunteer may be asked to return to the research center one more time to perform end of study procedures. At that time, he/she should return all of the study medication and supplies.

  • Will the records be kept confidential?

    Before enrolling in a research study the volunteer should ask who will have access to health records. In research, it is common for the sponsor of the study to review records. Records may also be reviewed by the US Food and Drug Administration (FDA) as well as an Institutional Review Board (IRB).

  • How do the risks, side effects and benefits in the study compare with the current treatment?

    Before agreeing to enroll in a research study he/she should understand what the risks, side effects and benefits are of taking the study medication versus those of other available treatment options.

  • Are there alternative treatments available?

    Before enrolling in a research study the volunteer should be made aware that other treatment options are available.

  • Who will pay medical expenses if the volunteer is injured as a result of their participation in the study and who should be contacted if injury occurs?

    In research, study related injuries are typically treated at no expense to the research volunteer. If a research related injury occurs the volunteer should notify the study coordinator or study doctor as soon as possible. The answers to these questions can also be found in the informed consent. When considering whether or not to participate in a research study, it is suggested that the copy given of the informed consent should be used for review and to be discussed with the primary care physician, family and friends of the participant.

  • Are Clinical Trials Safe?

    Researchers, doctors, and other health professionals conduct clinical trials according to strict rules set by the Food and Drug Administration (FDA). The FDA created these rules to protect clinical trial participants and to make sure they are treated as safely as possible. Clinical trials are also overseen by medical ethics groups to ensure that study participants are treated appropriately.

  • What Are The Benefits of Participating In A Clinical Trial?

    By participating in a clinical trial the participant will: •Get study related materials and medical care during the trial •Have access to new research treatments •Help others by contributing to medical research

  • What Are The Risks of Participating In A Clinical Trial?

    In clinical trials, some of the risks are known and some are unknown. Some risks are: •There may be unpleasant, serious, or even life-threatening side effects resulting from the study treatment •The study treatment may not be effective for the participant •The study may require more time and attention than the standard treatment requires such as, more visits to the clinic, keeping a treatment diary, and be subjected to additional tests.

  • Where Can I Get More Information About Clinical Trials?

    There are several organizations that offer information about clinical trials. Listed below are the organizations:
    www.fda.gov
    www.clinicaltrials.gov.
    www.centerwatch.com