Q: Why is clinical research important?
A: Clinical and Investigative research trials are designed to answer specific scientific questions to find better ways to prevent, detect or treat diseases or to improve care for people with diseases. These trials are designed to help determine the safety and effectiveness of new treatments, and represent new possibilities for patients facing a medical illness. Without clinical research, we cannot further the advancement of medicine and patient care.
Q: Who ensures that a trial is conducted ethically?
A: Clinical and investigative research that is conducted at CNI is overseen by an Institutional Review Boards (IRB) such as HCA-HealthONE IRB. The IRB’s main focus is to protect the rights, safety, and welfare of individuals enrolled in clinical trials. Secondly, it is the ultimate responsibility of Principal Investigators (PIs) to oversee the safe and ethical conduct of a clinical trial at their respective clinical sites.
Q: What are the risks involved?
A: The risks that are involved in a clinical trial vary according to the type of research study being conducted as well as the particular area of interest being investigated. The risk/benefit ratio for any clinical trial is monitored continually by the IRB and, in some cases, an independent data safety monitoring board (DSMB) that is adjudicated by the study sponsor. This continual monitoring ensures that any potential risks involved are minimized to ensure the safety of participating subjects.
Q: How long does a clinical study run?
A: The length of a clinical trial depends on what scientific questions are being asked as well as what disease field or condition it is focusing on. For example, at CNI, subjects enrolled in an acute stroke clinical trial will be monitored for an average of 3 months.
Q: How will this benefit me?
A: For the most part, clinical trials may or may not have a direct benefit to participating subjects. Generally, the more people who participate in clinical trials, the faster critical research questions can be answered that will lead to better treatment and prevention options in the future.
Q: Will I be compensated?
A: Compensation for participation in clinical trials varies on the trial that is being conducted. Each trial operates on a specific budget that may or may not allow for this compensation. A clinical trial that is investigating a specific type of experimental drug, device, or procedure will provide that at no cost to the subject.
Q: How do I know if I qualify for a clinical trial?
A: Each clinical trial being conducted has a specific set of inclusion/exclusion criteria that a subject must meet in order to be considered eligible. A subject must meet ALL of the inclusion criteria and NONE of the exclusion criteria in order to participate in a clinical trial. Inclusion/Exclusion criteria vary on the type of clinical trial and specific disease field or clinical condition it is focusing on.
Q: How do I consent to be in a clinical trial?
A: Before any study related procedure can begin, a subject must undergo a process called informed consent. This is a strict requirement set forth by the International Conference on Harmonisation (ICH) and enforced by the federal Food and Drug Administration (FDA). Each clinical trial has a specific document to ensure adequate informed consent. This informed consent document must be read, reviewed, understood and signed by the subject or their designated legal official/proxy decision maker.
Q: In a blinded study, will I find out what treatment I’ve been assigned to?
A: Most clinical trials are conducted using a process called blinding. This is where the subjects and the study doctors will not know the treatment subjects are being assigned to (either active treatment or placebo [non-active] treatment). This process is called randomization and means that subjects are randomly assigned (like flipping a coin). Blinding is necessary to ensure the integrity of the clinical trial being conducted and to lessen the chance of changes in health not attributable to medication or treatment – commonly referred to as the ‘placebo effect.’
Q: Can I withdraw at any point?
A: Participation in any clinical trial is completely voluntary. Enrolled subjects may choose to withdraw participation from the study at any time and for any reason.
Q: What do you do with my medical records?
A: Research subjects in clinical trials using the informed consent process are allowing the Principal Investigator and delegated study staff to access their personal health information (PHI)/medical records for purposes of conducting the clinical trial. PHI/medical records that are collected from subjects enrolled in clinical trials are ALWAYS kept in strict confidence by the study site where the trial is being conducted. These records are ALWAYS kept in a secure location and de-identified whenever possible to ensure each subject’s confidentiality.
Q: What other sites does CNI work with?
A: Research being conducted at CNI is in collaboration with physicians and staff at Swedish Medical Center, Blue Sky Neurology, Colorado Brain and Spine Institute, Neurology Care PC, Summit Headache and Neurologic Institute, Craig Hospital, National Jewish South Denver, Rocky Mountain Ear Center PC, St. Joseph Hospital-SCL Health and Denver Neurological Clinic.
Q: What’s the Principal Investigator’s experience?
A: Principal Investigators (PIs) must have adequate credentials in order to ensure safe and ethical conduct of a clinical trial at their respective sites. At CNI (as well as many sites across the US) this translates to medical doctors (MDs, DOs) who have adequately completed training in protection of human research participants and good clinical practice.
Q: What’s your experience as a research coordinator?
A: The clinical research coordinators at CNI have a combined total of more than 30 years of experience conducting clinical research!