Q: Who ensures that a trial is conducted ethically?
A: Clinical and Investigative research that is conducted at CNI is overseen by the 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 the Principal Investigator (PI) to oversee the safe and ethical conduct of a clinical trial at their respective clinical site.
Q: What are the risks involved?
A: The risks that are involved in a clinical trial vary according to the type of clinical trial that is being conducted as well as the particular area of interest being investigated by the clinical trial. The risk/benefit ratio for any clinical trial is monitored continually by the IRB and, in some instances, 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: 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 investigational drug, device, or procedure will provide that at no cost to the subject.
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: How will this benefit me?
A: For the most part, clinical trials may or may not have a direct benefit on participating subjects. 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 for people who are affected with disease and other clinical conditions in the future.
Q: How long does a clinical study run?
A: The length of a clinical trial depends on what scientific questions it is seeking to answer 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: What do you do with my medical records?
A: Subjects that agree to participate in a clinical trial through a process called informed consent, 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 that the trial is being conducted at. These records are ALWAYS kept in a secure location and de-identified whenever possible to ensure each subject’s confidentiality.
Q: What’s the Principal Investigator’s experience?
A: Principal Investigators (PI’s) must have adequate credentials in order to ensure safe and ethical conduct of a clinical trial at their respective site. At CNI (as well as many sites across the US) this translates to medical doctors (MD’s, DO’s) 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 experience of more than 10 years conducting clinical research!
Q: How do I know if I qualify for a clinical trial?
A: Each clinical trial that is conducted has a specific set of criteria that a subject must meet in order to be considered eligible to participate. These criteria are called inclusion/exclusion criteria. 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 be provided with and 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 you or your study doctor will not know the treatment that you have been assigned to (either active treatment or placebo [non active] treatment) via a process called randomization (being randomly assigned [like flipping a coin]). Blinding is necessary to ensure the integrity of the clinical trial being conducted and to mitigate 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 are the other sites involved?
A: Research being conducted at CNI is in collaboration with physicians and staff at Swedish Medical Center, Radiology Imaging Associates, Blue Sky Neurosciences, Colorado Brain and Spine Institute, Neurology Care P.C., Summit Headache and Neurologic, Craig Hospital, National Jewish South Denver, C Dermatology, Rocky Mountain Ear Center, P.C., and Denver Neurological Clinic.